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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-000473-20 | EudraCT Number |
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This low interventional study, whose unique intervention was to measure the blood level of a biomarker called NT-proBNP in chronic heart failure patients daily followed-up by Primary Care Physicians (PCPs) in Europe, assessed if the cardiologist referral guided by NT-proBNP measurement in patients who were currently judged by PCPs as being stable, would lead to optimization of HF treatment, defined in adherence to treatment recommendations of the current European Society of Cardiology guidelines for the treatment of heart failure.
In the majority of European countries, the primary management of chronic heart failure patients was performed by General Practitioners in collaboration with cardiologists (specialists). Previous studies had shown that many patients suffering from CHF do not receive optimal pharmacological and/or device treatment for their disease. An increase in natriuretic peptides (BNP, NT-proBNP) was associated with increased risk of cardiovascular events in heart failure patients. The purpose of the present study was to assess if a referral of clinical stable chronic heart failure patients with reduced ventricular ejection fraction (EF < or = 40%) and NT-proBNP level > or = 600 pg/mL to a specialist (cardiologist) led to treatment optimization, defined as adherence to the treatment recommendations according to the European Society of Cardiology (ESC) guidelines. In addition, data obtained in this study was used to describe demographic, clinical (including NT-proBNP levels) and treatment characteristics of CHF patients who were managed in the primary care setting across Europe..
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients' heart failure and non-heart failure | Other | No treatments are stipulated by this protocol - patients' HF and non-HF treatments will be observed throughout the study. The patients' treatment is entirely in the discretion of the primary care physicians |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard care | Procedure | Patients will receive the treatment that their primary care physician has decided to prescribe for their disease |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Clinically Stable Patients Whose Therapy Regimen Adheres to ESC Guideline Recommendations for Drug Types (Level 1) and Drug Type and Dose (Level 2) at Visit 1 (Before Referral to a Cardiologist) | Assessment of treatment regimen with respect to ESC guideline adherence at Visit 1 before referral to cardiologist. ESC Criteria for adherence: Drug Types: Treatment with (1) ACEi or (1) ARB in combination with (1) beta-blocker and (1) MRA for patients w/an LVEF ≤ 35% at V1. Treatment w/(1) ACEi or (1) ARB, in combination with (1) beta-blocker+ without treatment with an MRA for patients with an LVEF > 35% at visit 1. Drug type & dose: Guideline adherent with respect to drug types and dosage of all respective guideline drugs ≥ 50% of the recommended target dose. | Baseline (Visit 1) |
| Adherence to ESC Guideline at Visit 2 (After Referral to a Cardiologist, Month 6), for Follow-up Set: Drug Type and Drug Type and Dose | Assessment of patients' adherence at Visit 2, for patients who were already adherent at Visit 1, and those who were not adherent at Visit 1, for both drug type and drug type and dose. ESC Criteria for adherence: Drug Types: Treatment with (1) ACEi or (1) ARB in combination with (1) beta-blocker and (1) MRA for patients w/an LVEF ≤ 35% at V1. Treatment w/(1) ACEi or (1) ARB, in combination with (1) beta-blocker+ without treatment with an MRA for patients with an LVEF > 35% at visit 1. Drug type & dose: Guideline adherent with respect to drug types and dosage of all respective guideline drugs ≥ 50% of the recommended target dose. | Month 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Heart Failure | The duration of Heart Failure was collected at Baseline (Visit 1). | Baseline (Visit 1) |
| Number of Patients With Current Use of Concomitant Compound | Use of concomitant compounds were collected at baseline (Visit 1) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Kluisbergen | Belgium | 9690 | Belgium | ||
| Novartis Investigative Site |
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
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The enrolled set consisted of 1415 patients. 861 patients were referred to a cardiologist within this study and Based on findings from the interim-analysis, Novartis decided to terminate the study prematurely in March 2018.
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| ID | Title | Description |
|---|---|---|
| FG000 | Enrolled Patients | Adult male and female patients with chronic heart failure with reduced ejection fraction (LVEF ≤ 40%) who were managed in a primary care setting in sites across Europe. Patients who were considered clinically stable with NT-proBNP levels > 600 pg/ml were described and analyzed in the Follow-Up set. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Enrolled Set |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 15, 2016 | Mar 21, 2019 |
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| Baseline (Visit 1) |
| Number of Follow-Up Patients With Current Use of Concomitant Compound at Visit 2 | Use of concomitant compounds were collected at 6 months (Visit 2) | 6 months (Visit 2) |
| Percentages of Clinically Stable Patients for Whom the Cardiologist and/or Primary Care Physician Optimizes Treatment Post Referral, Stratified According to Key Baseline Characteristics | For patients who enter the prospective period of the study the post-referral treatment choice of cardiologists and/or primary care physicians was documented; for patients, for whom the cardiologist and/or primary care physician chose to prescribe a novel Heart Failure treatment, the treatment was assessed, if it fulfills the definition of adherence to European Society of Cardiology (ESC) guideline recommendation. The proportion of patients for whom an ESC guideline adherent treatment was de novo prescribed was assessed stratified according to different parameters. | 6 months |
| Number of Patients With Different NT-proBNP Level Categories | NT-proBNP levels (pg/ml) was measured at baseline in all consecutive patients who satisfy the inclusion and exclusion criteria. Measurements were performed on-site by means of a handheld device provided for the purposes of the study. NT-proBNP level categories could be 600 -799 pg/ml, 800 - 999 pg/ml, 1000 - 1200 pg/ml, > 1200 pg/ml). | One measurement in all consecutive patients at baseline (Visit 1) |
| Percentages of Clinically Stable Patients | Clinically stable patients in this study were defined as those patients for whom the primary care physician did not see a necessity (based on signs and symptoms of HF) to change the current pharmacological and/or device treatment of HF and who were on stable pharmacological and/or device treatment for HF for at least 3 months prior to inclusion. | Baseline (Visit 1) |
| Number of Patients by Cardiologist Prescription Practice Per Country/Region | The cardiologists' suggestions for pharmacological and/or device therapy for the treatment of clinically stable CHF patients was documented and assessed by means of descriptive statistical measures stratified by country/region 6 months after baseline. | 6 months |
| Change of NT-proBNP Levels in Clinically Stable Chronic Heart Failure Patients With and Without Treatment Optimization 10 Months After Baseline | At 10 months after baseline (end of study) NT-proBNP was assessed in clinically stable CHF patients with baseline NT-proBNP levels ≥ 600 pg/ml. Thus, for those patients two NT-proBNP measurements were available: at baseline and 10 months later. The individual change of NT-proBNP between both time points were assessed in accordance to the patients' treatment history during the study, i.e. baseline Heart Failure treatment and therapeutic decision taken 6 months after baseline. | 10 months |
| Change in EuroQol Five Dimensions Questionnaire (EQ-5D) Total and Individual Sub-scores at Visit 1 (Baseline), Visit 2 (6 Months) and Visit 3 (10 Months) | Quality of life (QoL) was assessed by EQ-5D including the dimensions mobility, self-care, usual activity, pain/discomfort, anxiety/depression. A utility index based on UK value sets was built to summarize the information of these five dimensions into a single scale. The utility index can range between -0.281 and 1.0 where a higher number indicates a better health status. In addition, a visual analog scale (VAS) was applied with a possible range between 0 (=worst imaginable health state) and 100 (=best imaginable health state). Scores collected for all patients at baseline (Visit 1) and at Visit 2 and Visit 3 (only patients who entered the prospective period of the study, i.e. clinically stable patients with a NT-proBNP level ≥ 600 pg/ml) were asked to fill out the EuroQol 5D (EQ-5D) quality of life (QoL) questionnaire validated for heart failure (HF). | Baseline (Visit 1), 6 months (Visit 2), 10 months (Visit 3) |
| Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Total and Individual Sub-scores at Visit 1 (Baseline), Visit 2 (6 Months) and Visit 3 (10 Months) | The KCCQ is a self-administered questionnaire. It contains 23 items, covering physical function, clinical symptoms, social function, self-efficacy and knowledge, and quality of life, each with different Likert scale wording, including limitations, frequency, bother, change in condition, understanding, levels of enjoyment and satisfaction. Scores are transformed to a range of 0-100, in which higher scores reflect better health status. A positive change from baseline indicates improvement. Scores were collected for all patients at baseline and Visit 2 and Visit 3 (only patients who had entered the prospective period of the study (clinically stable patients with a NT-proBNP level ≥ 600 pg/ml) were asked to complete Kansas City Cardiomyopathy Questionnaire (KCCQ) validated for Heart Failure. | Baseline (Visit 1), 6 months (Visit 2), 10 months (Visit 3) |
| Number of Patients in Different Living Conditions | Living conditions were collected at Baseline (Visit 1). | Baseline (Visit 1) |
| Number of Patients in Different Employment Status | Employment status was collected at Baseline (Visit 1). | Baseline (Visit 1) |
| Number of Patients With Smoking Status | Smoking status was collected at baseline (visit 1). | Baseline (Visit 1) |
| Number of Patients From Different Geographical Regions | Geographic regions were collected at Baseline (Visit 1). | Baseline (visit 1) |
| Number of Patients With Health Insurance Status | Health insurance status was collected at Baseline (Visit 1). | Baseline (Visit 1) |
| Number of Patients at Different Educational Level | Educational level was collected at Baseline (Visit 1). | Baseline (Visit 1) |
| Number of Patients Per Primary Etiology of Heart Failure | The primary etiology of Heart Failure was collected at Baseline (Visit 1). | Baseline (Visit 1) |
| Number of Patients With Heart Failure (HF)-Related Hospitalizations in the Previous 12 Months Prior to Baseline, and During the Study | HF-related hospitalizations was collected in the previous 12 months prior to baseline at baseline visit, at 6 and 10 months post-baseline. | Baseline (Visit 1), 6 months, 10 months |
| Percentage of Patients With Cardiovascular and Non-cardiovascular Co-morbidities | Cardiovascular and non-cardiovascular co-morbidities were collected at baseline (Visit 1) | Baseline (Visit 1) |
| Mean Dose of Previously Taken and Current Use of Concomitant Medications | Mean Dose of previously taken and current use of concomitant medications was to be collected at Visit 1, 6 months, 10 months post-baseline | Baseline (Visit 1), 6 months, 10 months |
| Number of Heart Failure (HF) Treatment Combinations | The types and number of participants with HF treatment combinations were collected at Baseline (Visit 1). | Baseline (Visit 1) |
| Duration of Treatment With Device Type | The duration of treatment with device type was collected at baseline (Visit 1) | Baseline (Visit 1) |
| Duration of Previously Taken and Currently Use of Most Common Non-Heart Failure Concomitant Compounds | Duration of most common previously taken and current use of most common Non-HF concomitant compounds were collected | Baseline (Visit 1) |
| Number of Patients by Primary Care Physicians' Prescription Practice Per Country/Region | For clinically stable CHF patients, the primary care physicians' prescription of pharmacological and device treatment for HF was to be documented prior to baseline and post cardiologist-referral. At the post-referral visit the degree of implementation of cardiologist-recommendations and the medical decision making (e.g. reasons for non-implementation) were to be documented. | Baseline (Visit 1) |
| Binkom |
| BEL |
| 3211 |
| Belgium |
| Novartis Investigative Site | Gozée | BEL | 6534 | Belgium |
| Novartis Investigative Site | Linkebeek | BEL | 1630 | Belgium |
| Novartis Investigative Site | Oostham | BEL | 3945 | Belgium |
| Novartis Investigative Site | Zichem | BEL | 3271 | Belgium |
| Novartis Investigative Site | Aarschot | 3200 | Belgium |
| Novartis Investigative Site | Alveringem | 8691 | Belgium |
| Novartis Investigative Site | Boezinge | 8904 | Belgium |
| Novartis Investigative Site | Bruxe | 1080 | Belgium |
| Novartis Investigative Site | Buggenhout, Belgium | 9255 | Belgium |
| Novartis Investigative Site | Deinze | 9800 | Belgium |
| Novartis Investigative Site | Deurne | 2100 | Belgium |
| Novartis Investigative Site | Diksmuide | 8600 | Belgium |
| Novartis Investigative Site | Ezemaal-Neerwinden | 3400 | Belgium |
| Novartis Investigative Site | Hasselt | 3500 | Belgium |
| Novartis Investigative Site | Hasselt, Belgium | 3500 | Belgium |
| Novartis Investigative Site | Herzele | 9550 | Belgium |
| Novartis Investigative Site | Landen | 3400 | Belgium |
| Novartis Investigative Site | Leefdaal | 3060 | Belgium |
| Novartis Investigative Site | Linkebeek | 1630 | Belgium |
| Novartis Investigative Site | Lommel | 3920 | Belgium |
| Novartis Investigative Site | Maasmechelen | 3630 | Belgium |
| Novartis Investigative Site | Mont-sur-Marchienne | 6032 | Belgium |
| Novartis Investigative Site | Nazareth | 9810 | Belgium |
| Novartis Investigative Site | Oosteeklo | 9988 | Belgium |
| Novartis Investigative Site | Ostend | Belgium |
| Novartis Investigative Site | Oudenaarde | 9700 | Belgium |
| Novartis Investigative Site | Saint-Médard | 6887 | Belgium |
| Novartis Investigative Site | Stoumont | 4987 | Belgium |
| Novartis Investigative Site | Tessenderlo | 3980 | Belgium |
| Novartis Investigative Site | Thuilles | 6536 | Belgium |
| Novartis Investigative Site | Tielt-Winge | 3390 | Belgium |
| Novartis Investigative Site | Tremelo | 3120 | Belgium |
| Novartis Investigative Site | Vilvoorde | 1800 | Belgium |
| Novartis Investigative Site | Waregem | 8790 | Belgium |
| Novartis Investigative Site | HRV | Croatia | 10000 | Croatia |
| Novartis Investigative Site | HRV | Croatia | 31000 | Croatia |
| Novartis Investigative Site | HRV | Croatia | 44320 | Croatia |
| Novartis Investigative Site | Rijeka | HRV | 51000 | Croatia |
| Novartis Investigative Site | Višnjevac | HRV | 31220 | Croatia |
| Novartis Investigative Site | Zagreb | HRV | 10000 | Croatia |
| Novartis Investigative Site | Bizovac | 31222 | Croatia |
| Novartis Investigative Site | HRV | 42000 | Croatia |
| Novartis Investigative Site | Krasica | 51224 | Croatia |
| Novartis Investigative Site | Osijek | 31000 | Croatia |
| Novartis Investigative Site | Rijeka | 51000 | Croatia |
| Novartis Investigative Site | Slavonski Brod | 35000 | Croatia |
| Novartis Investigative Site | Velika Kopanica | 35221 | Croatia |
| Novartis Investigative Site | Viškovo | 51216 | Croatia |
| Novartis Investigative Site | Zagreb | 10000 | Croatia |
| Novartis Investigative Site | Nicosia | 2048 | Cyprus |
| Novartis Investigative Site | Nicosia | 2540 | Cyprus |
| Novartis Investigative Site | Præstø | 4720 | Denmark |
| Novartis Investigative Site | Skive | 7800 | Denmark |
| Novartis Investigative Site | Sõmeru | EST | 44201 | Estonia |
| Novartis Investigative Site | Paide | 72713 | Estonia |
| Novartis Investigative Site | Tallinn | 10138 | Estonia |
| Novartis Investigative Site | Tallinn | 11911 | Estonia |
| Novartis Investigative Site | Tallinn | 13415 | Estonia |
| Novartis Investigative Site | Breteuil Sur Seine | France | 27160 | France |
| Novartis Investigative Site | Arras | 62000 | France |
| Novartis Investigative Site | Bersée | 59254 | France |
| Novartis Investigative Site | Cannes | 06400 | France |
| Novartis Investigative Site | Chantepie | 35135 | France |
| Novartis Investigative Site | Colombiers | 31770 | France |
| Novartis Investigative Site | Coursan | 11110 | France |
| Novartis Investigative Site | Erquy | 22430 | France |
| Novartis Investigative Site | La Seyne-sur-Mer | 83500 | France |
| Novartis Investigative Site | Laval | 53000 | France |
| Novartis Investigative Site | Les Pennes-Mirabeau | 13170 | France |
| Novartis Investigative Site | Nègrepelisse | 82800 | France |
| Novartis Investigative Site | Orthez | 64300 | France |
| Novartis Investigative Site | Paris | 75010 | France |
| Novartis Investigative Site | Paris | 75020 | France |
| Novartis Investigative Site | Rosiers d'Egleton | 19300 | France |
| Novartis Investigative Site | Saint-Orens-de-Gameville | 31650 | France |
| Novartis Investigative Site | Salles | 33770 | France |
| Novartis Investigative Site | Six-Fours-les-Plages | 83140 | France |
| Novartis Investigative Site | Strasbourg | 67200 | France |
| Novartis Investigative Site | Balatonkeresztúr | 8647 | Hungary |
| Novartis Investigative Site | Budapest | 1136 | Hungary |
| Novartis Investigative Site | Csongrád | 6640 | Hungary |
| Novartis Investigative Site | Érd | 2030 | Hungary |
| Novartis Investigative Site | Felsőrajk | 8767 | Hungary |
| Novartis Investigative Site | Hosszúhetény | 7694 | Hungary |
| Novartis Investigative Site | Kecskemét | 6000 | Hungary |
| Novartis Investigative Site | Korondi | 6726 | Hungary |
| Novartis Investigative Site | Nyíregyháza | 4400 | Hungary |
| Novartis Investigative Site | Pécs | 7632 | Hungary |
| Novartis Investigative Site | Szabadsag | 6756 | Hungary |
| Novartis Investigative Site | Szeged-Szoreg | H-6771 | Hungary |
| Novartis Investigative Site | Székesfehérvár | 8000 | Hungary |
| Novartis Investigative Site | Törökbálint | 2045 | Hungary |
| Novartis Investigative Site | Zákányszék | 6787 | Hungary |
| Novartis Investigative Site | Beersheba | 8477713 | Israel |
| Novartis Investigative Site | Grumello del Monte | BG | 24064 | Italy |
| Novartis Investigative Site | Gatteo | FC | 47043 | Italy |
| Novartis Investigative Site | Jelgava | LVA | LV-3001 | Latvia |
| Novartis Investigative Site | Riga | LVA | LV 1010 | Latvia |
| Novartis Investigative Site | Riga | 1012 | Latvia |
| Novartis Investigative Site | Riga | LV-1006 | Latvia |
| Novartis Investigative Site | Riga | LV-1021 | Latvia |
| Novartis Investigative Site | Kaunas | LTU | LT 45488 | Lithuania |
| Novartis Investigative Site | Kaunas | LTU | LT 50161 | Lithuania |
| Novartis Investigative Site | Klaipėda | LTU | 92304 | Lithuania |
| Novartis Investigative Site | Alytus | LT-62386 | Lithuania |
| Novartis Investigative Site | Kaunas | LT-49387 | Lithuania |
| Novartis Investigative Site | Kaunas | LT-49449 | Lithuania |
| Novartis Investigative Site | Vilnius | LT-08661 | Lithuania |
| Novartis Investigative Site | Xaghra | Gozo | XRA 2405 | Malta |
| Novartis Investigative Site | Xewkija | Gozo | VCT 110 | Malta |
| Novartis Investigative Site | Rabat | Malta |
| Novartis Investigative Site | Ostereidet | Norway | 5993 | Norway |
| Novartis Investigative Site | Flisa | 2270 | Norway |
| Novartis Investigative Site | Hamar | 2317 | Norway |
| Novartis Investigative Site | Hønefoss | 3515 | Norway |
| Novartis Investigative Site | Kirkenær | 2260 | Norway |
| Novartis Investigative Site | Lierskogen | N-3420 | Norway |
| Novartis Investigative Site | Lørenskog | 1473 | Norway |
| Novartis Investigative Site | Løten | 2340 | Norway |
| Novartis Investigative Site | Noetteroey | 3163 | Norway |
| Novartis Investigative Site | Skien | 3734 | Norway |
| Novartis Investigative Site | Chełm | POL | 22-100 | Poland |
| Novartis Investigative Site | Kartuzy | POL | 83-300 | Poland |
| Novartis Investigative Site | Warsaw | POL | 00-874 | Poland |
| Novartis Investigative Site | Bialystok | 15-746 | Poland |
| Novartis Investigative Site | Bialystok | 15-867 | Poland |
| Novartis Investigative Site | Bielawa | 58-260 | Poland |
| Novartis Investigative Site | Bydgoszcz | 85-021 | Poland |
| Novartis Investigative Site | Dzierżoniów | 58-200 | Poland |
| Novartis Investigative Site | Katowice | 40-018 | Poland |
| Novartis Investigative Site | Krakow | 30 415 | Poland |
| Novartis Investigative Site | Krakow | 30-664 | Poland |
| Novartis Investigative Site | Krakow | 31-061 | Poland |
| Novartis Investigative Site | Lublin | 20-094 | Poland |
| Novartis Investigative Site | Miasteczko Śląskie | 42-610 | Poland |
| Novartis Investigative Site | Poznan | 61-388 | Poland |
| Novartis Investigative Site | Warsaw | 01-493 | Poland |
| Novartis Investigative Site | Warsaw | 01-887 | Poland |
| Novartis Investigative Site | Warsaw | 03 185 | Poland |
| Novartis Investigative Site | Wieleń | 64-730 | Poland |
| Novartis Investigative Site | Wroclaw | 54-703 | Poland |
| Novartis Investigative Site | Zgierz | 95-100 | Poland |
| Novartis Investigative Site | Seixal | Bairro Novo | 2840 481 | Portugal |
| Novartis Investigative Site | Cantanhede | 3060 123 | Portugal |
| Novartis Investigative Site | Leça da Palmeira | 4450 586 | Portugal |
| Novartis Investigative Site | Lisbon | 1200 375 | Portugal |
| Novartis Investigative Site | Lisbon | 1250 210 | Portugal |
| Novartis Investigative Site | Lisbon | 1800 192 | Portugal |
| Novartis Investigative Site | Oeiras | 2780 163 | Portugal |
| Novartis Investigative Site | Kazan' | 420012 | Russia |
| Novartis Investigative Site | Moscow | 121374 | Russia |
| Novartis Investigative Site | Moscow | 121552 | Russia |
| Novartis Investigative Site | Moscow | 127015 | Russia |
| Novartis Investigative Site | Moscow | 127206 | Russia |
| Novartis Investigative Site | Petrozavodsk | 185019 | Russia |
| Novartis Investigative Site | Saint Petersburg | 197110 | Russia |
| Novartis Investigative Site | Saint Petersburg | 199106 | Russia |
| Novartis Investigative Site | Ufa | 450000 | Russia |
| Novartis Investigative Site | Vladivostok | 690002 | Russia |
| Novartis Investigative Site | Yaroslavl | 150047 | Russia |
| Novartis Investigative Site | Ivančna Gorica | 1295 | Slovenia |
| Novartis Investigative Site | Kranj | 4000 | Slovenia |
| Novartis Investigative Site | Ljubljana | 1000 | Slovenia |
| Novartis Investigative Site | Maribor | 2000 | Slovenia |
| Novartis Investigative Site | Pesnica | 2211 | Slovenia |
| Novartis Investigative Site | Slovenske Konjice | 3210 | Slovenia |
| Novartis Investigative Site | Spodnji Duplek | 2241 | Slovenia |
| Novartis Investigative Site | Vrhnika | 1360 | Slovenia |
| Novartis Investigative Site | Žalec | 3310 | Slovenia |
| Novartis Investigative Site | Cambre | A Coruna | 15660 | Spain |
| Novartis Investigative Site | Porto do Son | A Coruña | 15970 | Spain |
| Novartis Investigative Site | Petrel | Alicante | 03610 | Spain |
| Novartis Investigative Site | El Parador de Las Hortichiuela | Almeria | 04720 | Spain |
| Novartis Investigative Site | Alcúdia | Balearic Islands | 07400 | Spain |
| Novartis Investigative Site | El Cañaveral | Caceres | 10820 | Spain |
| Novartis Investigative Site | Puerto Real | Cadiz | 11510 | Spain |
| Novartis Investigative Site | Burriana | Castellon | 12530 | Spain |
| Novartis Investigative Site | Telde | Las Palmas de Gran Canaria | 35215 | Spain |
| Novartis Investigative Site | Parla | Madrid | 28982 | Spain |
| Novartis Investigative Site | A Estrada | Pontevedra | 36681 | Spain |
| Novartis Investigative Site | Monteporeiro | Pontevedra | 36162 | Spain |
| Novartis Investigative Site | Oviedo | Principality of Asturias | 33009 | Spain |
| Novartis Investigative Site | Oviedo | Principality of Asturias | 33013 | Spain |
| Novartis Investigative Site | A Coruña | 15007 | Spain |
| Novartis Investigative Site | Alicante | 03540 | Spain |
| Novartis Investigative Site | Madrid | 28030 | Spain |
| Novartis Investigative Site | Madrid | 28032 | Spain |
| Novartis Investigative Site | Madrid | 28033 | Spain |
| Novartis Investigative Site | Panxón | 36340 | Spain |
| COMPLETED |
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| NOT COMPLETED |
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| Follow-Up Set |
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| ID | Title | Description |
|---|---|---|
| BG000 | Enrolled Patients | Adult male and female patients with chronic heart failure with reduced ejection fraction (LVEF ≤ 40%) who were managed in a primary care setting in sites across Europe. Patients who were considered clinically stable an with NT-proBNP levels > 600 pg/ml were referred to a cardiologist for evaluation and were in the follow-up set. |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
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| Age, Continuous | Mean | Standard Deviation | Years |
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| Age, Customized | Enrolled Set | Number | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
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| Primary | Number of Clinically Stable Patients Whose Therapy Regimen Adheres to ESC Guideline Recommendations for Drug Types (Level 1) and Drug Type and Dose (Level 2) at Visit 1 (Before Referral to a Cardiologist) | Assessment of treatment regimen with respect to ESC guideline adherence at Visit 1 before referral to cardiologist. ESC Criteria for adherence: Drug Types: Treatment with (1) ACEi or (1) ARB in combination with (1) beta-blocker and (1) MRA for patients w/an LVEF ≤ 35% at V1. Treatment w/(1) ACEi or (1) ARB, in combination with (1) beta-blocker+ without treatment with an MRA for patients with an LVEF > 35% at visit 1. Drug type & dose: Guideline adherent with respect to drug types and dosage of all respective guideline drugs ≥ 50% of the recommended target dose. | Enrolled and Follow-up Set included. Due to missing left ventricular ejection fraction (LVEF) values, some patients could not be classified. | Posted | Number | Participants | Baseline (Visit 1) |
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| Primary | Adherence to ESC Guideline at Visit 2 (After Referral to a Cardiologist, Month 6), for Follow-up Set: Drug Type and Drug Type and Dose | Assessment of patients' adherence at Visit 2, for patients who were already adherent at Visit 1, and those who were not adherent at Visit 1, for both drug type and drug type and dose. ESC Criteria for adherence: Drug Types: Treatment with (1) ACEi or (1) ARB in combination with (1) beta-blocker and (1) MRA for patients w/an LVEF ≤ 35% at V1. Treatment w/(1) ACEi or (1) ARB, in combination with (1) beta-blocker+ without treatment with an MRA for patients with an LVEF > 35% at visit 1. Drug type & dose: Guideline adherent with respect to drug types and dosage of all respective guideline drugs ≥ 50% of the recommended target dose. | Follow-Up set | Posted | Number | Percentage of Patients | Month 6 |
|
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| Secondary | Duration of Heart Failure | The duration of Heart Failure was collected at Baseline (Visit 1). | Enrolled Set and Follow-Up Set | Posted | Number | Participants | Baseline (Visit 1) |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Number of Patients With Current Use of Concomitant Compound | Use of concomitant compounds were collected at baseline (Visit 1) | Enrolled Set and Follow-Up Set | Posted | Number | Participants | Baseline (Visit 1) |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Number of Follow-Up Patients With Current Use of Concomitant Compound at Visit 2 | Use of concomitant compounds were collected at 6 months (Visit 2) | Follow-Up Set | Posted | Number | Participants | 6 months (Visit 2) |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Percentages of Clinically Stable Patients for Whom the Cardiologist and/or Primary Care Physician Optimizes Treatment Post Referral, Stratified According to Key Baseline Characteristics | For patients who enter the prospective period of the study the post-referral treatment choice of cardiologists and/or primary care physicians was documented; for patients, for whom the cardiologist and/or primary care physician chose to prescribe a novel Heart Failure treatment, the treatment was assessed, if it fulfills the definition of adherence to European Society of Cardiology (ESC) guideline recommendation. The proportion of patients for whom an ESC guideline adherent treatment was de novo prescribed was assessed stratified according to different parameters. | Follow-Up Set | Posted | Number | Percentage of Patients | 6 months |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Number of Patients With Different NT-proBNP Level Categories | NT-proBNP levels (pg/ml) was measured at baseline in all consecutive patients who satisfy the inclusion and exclusion criteria. Measurements were performed on-site by means of a handheld device provided for the purposes of the study. NT-proBNP level categories could be 600 -799 pg/ml, 800 - 999 pg/ml, 1000 - 1200 pg/ml, > 1200 pg/ml). | Enrolled Set and Follow-Up Set | Posted | Number | Participants | One measurement in all consecutive patients at baseline (Visit 1) |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Percentages of Clinically Stable Patients | Clinically stable patients in this study were defined as those patients for whom the primary care physician did not see a necessity (based on signs and symptoms of HF) to change the current pharmacological and/or device treatment of HF and who were on stable pharmacological and/or device treatment for HF for at least 3 months prior to inclusion. | Enrolled Set | Posted | Number | Percentage of Participants | Baseline (Visit 1) |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Number of Patients by Cardiologist Prescription Practice Per Country/Region | The cardiologists' suggestions for pharmacological and/or device therapy for the treatment of clinically stable CHF patients was documented and assessed by means of descriptive statistical measures stratified by country/region 6 months after baseline. | Follow-Up Set | Posted | Number | Number of Participants | 6 months |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Change of NT-proBNP Levels in Clinically Stable Chronic Heart Failure Patients With and Without Treatment Optimization 10 Months After Baseline | At 10 months after baseline (end of study) NT-proBNP was assessed in clinically stable CHF patients with baseline NT-proBNP levels ≥ 600 pg/ml. Thus, for those patients two NT-proBNP measurements were available: at baseline and 10 months later. The individual change of NT-proBNP between both time points were assessed in accordance to the patients' treatment history during the study, i.e. baseline Heart Failure treatment and therapeutic decision taken 6 months after baseline. | Follow-Up Set | Posted | Mean | Standard Deviation | pg/mL | 10 months |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Change in EuroQol Five Dimensions Questionnaire (EQ-5D) Total and Individual Sub-scores at Visit 1 (Baseline), Visit 2 (6 Months) and Visit 3 (10 Months) | Quality of life (QoL) was assessed by EQ-5D including the dimensions mobility, self-care, usual activity, pain/discomfort, anxiety/depression. A utility index based on UK value sets was built to summarize the information of these five dimensions into a single scale. The utility index can range between -0.281 and 1.0 where a higher number indicates a better health status. In addition, a visual analog scale (VAS) was applied with a possible range between 0 (=worst imaginable health state) and 100 (=best imaginable health state). Scores collected for all patients at baseline (Visit 1) and at Visit 2 and Visit 3 (only patients who entered the prospective period of the study, i.e. clinically stable patients with a NT-proBNP level ≥ 600 pg/ml) were asked to fill out the EuroQol 5D (EQ-5D) quality of life (QoL) questionnaire validated for heart failure (HF). | Enrolled Set for Visit 1 (Baseline) and Follow-Up Set (Visit 2 and 3) for those clinically stable patients who entered the prospective period of the study | Posted | Median | Full Range | Scores on a scale | Baseline (Visit 1), 6 months (Visit 2), 10 months (Visit 3) |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Total and Individual Sub-scores at Visit 1 (Baseline), Visit 2 (6 Months) and Visit 3 (10 Months) | The KCCQ is a self-administered questionnaire. It contains 23 items, covering physical function, clinical symptoms, social function, self-efficacy and knowledge, and quality of life, each with different Likert scale wording, including limitations, frequency, bother, change in condition, understanding, levels of enjoyment and satisfaction. Scores are transformed to a range of 0-100, in which higher scores reflect better health status. A positive change from baseline indicates improvement. Scores were collected for all patients at baseline and Visit 2 and Visit 3 (only patients who had entered the prospective period of the study (clinically stable patients with a NT-proBNP level ≥ 600 pg/ml) were asked to complete Kansas City Cardiomyopathy Questionnaire (KCCQ) validated for Heart Failure. | Enrolled Set for Visit 1 (Baseline) and Follow-Up Set (Visit 2 and 3) for those clinically stable patients who entered the prospective period of the study | Posted | Median | Full Range | Utility Index Score | Baseline (Visit 1), 6 months (Visit 2), 10 months (Visit 3) |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Number of Patients in Different Living Conditions | Living conditions were collected at Baseline (Visit 1). | Enrolled Set and Follow-Up Set | Posted | Number | Number of Participants | Baseline (Visit 1) |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Number of Patients in Different Employment Status | Employment status was collected at Baseline (Visit 1). | Enrolled Set and Follow-Up Set | Posted | Number | Number of Participants | Baseline (Visit 1) |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Number of Patients With Smoking Status | Smoking status was collected at baseline (visit 1). | Enrolled Set and Follow-Up Set | Posted | Number | Number of Participants | Baseline (Visit 1) |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Number of Patients From Different Geographical Regions | Geographic regions were collected at Baseline (Visit 1). | Enrolled Set | Posted | Number | Number of Participants | Baseline (visit 1) |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Number of Patients With Health Insurance Status | Health insurance status was collected at Baseline (Visit 1). | Enrolled Set and Follow-Up Set | Posted | Number | Number of Participants | Baseline (Visit 1) |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Number of Patients at Different Educational Level | Educational level was collected at Baseline (Visit 1). | Enrolled Set and Follow-Up Set | Posted | Number | Number of Participants | Baseline (Visit 1) |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Number of Patients Per Primary Etiology of Heart Failure | The primary etiology of Heart Failure was collected at Baseline (Visit 1). | Enrolled Set and Follow-Up Set | Posted | Number | Number of Participants | Baseline (Visit 1) |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Number of Patients With Heart Failure (HF)-Related Hospitalizations in the Previous 12 Months Prior to Baseline, and During the Study | HF-related hospitalizations was collected in the previous 12 months prior to baseline at baseline visit, at 6 and 10 months post-baseline. | Enrolled Set and Follow-Up Set | Posted | Number | Number of Participants | Baseline (Visit 1), 6 months, 10 months |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Patients With Cardiovascular and Non-cardiovascular Co-morbidities | Cardiovascular and non-cardiovascular co-morbidities were collected at baseline (Visit 1) | Enrolled Set and Follow-Up Set | Posted | Number | Percentage of Participants | Baseline (Visit 1) |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Mean Dose of Previously Taken and Current Use of Concomitant Medications | Mean Dose of previously taken and current use of concomitant medications was to be collected at Visit 1, 6 months, 10 months post-baseline | Enrolled Set and Follow-Up Set (Mean dose of concomitant medications was not collected/provided and could not be alternately computed based upon the information listed). | Posted | Baseline (Visit 1), 6 months, 10 months |
|
| |||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Heart Failure (HF) Treatment Combinations | The types and number of participants with HF treatment combinations were collected at Baseline (Visit 1). | Follow-Up Set: Patients who were considered clinically stable and had NT-proBNP levels > 600 pg/ml who were referred to a cardiologist at Baseline (Visit 1) for evaluation. | Posted | Number | Number of Participants | Baseline (Visit 1) |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Duration of Treatment With Device Type | The duration of treatment with device type was collected at baseline (Visit 1) | Follow-Up Set (Data was not collected for this endpoint) | Posted | Baseline (Visit 1) |
|
| |||||||||||||||||||||||||||||||||||||||
| Secondary | Duration of Previously Taken and Currently Use of Most Common Non-Heart Failure Concomitant Compounds | Duration of most common previously taken and current use of most common Non-HF concomitant compounds were collected | Follow-Up Set | Posted | Number | Percentage of participants | Baseline (Visit 1) |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Number of Patients by Primary Care Physicians' Prescription Practice Per Country/Region | For clinically stable CHF patients, the primary care physicians' prescription of pharmacological and device treatment for HF was to be documented prior to baseline and post cardiologist-referral. At the post-referral visit the degree of implementation of cardiologist-recommendations and the medical decision making (e.g. reasons for non-implementation) were to be documented. | Follow-Up Set (Data was not collected for this endpoint.) | Posted | Baseline (Visit 1) |
|
|
Adverse Events were collected from FPFV to LPLV up to 2 years.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Enrolled Set | Adult male and female patients with chronic heart failure with reduced ejection fraction (LVEF ≤ 40%) who were managed in a primary care setting in sites across Europe. | 32 | 1,415 | 117 | 1,415 | 187 | 1,415 |
| EG001 | Follow-Up Set | Patients who were considered clinically stable and with NT-proBNP levels > 600 pg/ml who were referred to a cardiologist at Visit 1 for evaluation were in the follow-up set. | 30 | 861 | 114 | 861 | 181 | 861 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Angina unstable | Cardiac disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Arrhythmia | Cardiac disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Atrioventricular block | Cardiac disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Cardiac failure acute | Cardiac disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Cardiac failure chronic | Cardiac disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Ventricular extrasystoles | Cardiac disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Ventricular tachycardia | Cardiac disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Gastric haemorrhage | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Gastric ulcer | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Melaena | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Short-bowel syndrome | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Death | General disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Soft tissue inflammation | General disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Sudden cardiac death | General disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Sudden death | General disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Ulcer haemorrhage | General disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Bacterial infection | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Epididymitis | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Erysipelas | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Intestinal gangrene | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Orchitis | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Otitis externa | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment |
| |
| Electric shock | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment |
| |
| Fracture | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment |
| |
| Head injury | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment |
| |
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment |
| |
| Subarachnoid haemorrhage | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment |
| |
| Wrist fracture | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment |
| |
| International normalised ratio increased | Investigations | MedDRA (20.1) | Systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Fluid overload | Metabolism and nutrition disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Lumbar spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Brain neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (20.1) | Systematic Assessment |
| |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (20.1) | Systematic Assessment |
| |
| Neuroendocrine tumour | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (20.1) | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Device malfunction | Product Issues | MedDRA (20.1) | Systematic Assessment |
| |
| Delirium | Psychiatric disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Endometrial hyperplasia | Reproductive system and breast disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Uterovaginal prolapse | Reproductive system and breast disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Orthopnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Pulmonary mass | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Ischaemic skin ulcer | Skin and subcutaneous tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Homicide | Social circumstances | MedDRA (20.1) | Systematic Assessment |
| |
| Aortic valve repair | Surgical and medical procedures | MedDRA (20.1) | Systematic Assessment |
| |
| Cardiac ablation | Surgical and medical procedures | MedDRA (20.1) | Systematic Assessment |
| |
| Cardiac pacemaker insertion | Surgical and medical procedures | MedDRA (20.1) | Systematic Assessment |
| |
| Cardiac resynchronisation therapy | Surgical and medical procedures | MedDRA (20.1) | Systematic Assessment |
| |
| Cardioversion | Surgical and medical procedures | MedDRA (20.1) | Systematic Assessment |
| |
| Circulatory collapse | Vascular disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Peripheral artery thrombosis | Vascular disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Vasculitis | Vascular disorders | MedDRA (20.1) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Arteriosclerosis coronary artery | Cardiac disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Cardio-respiratory arrest | Cardiac disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Hypertensive cardiomyopathy | Cardiac disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Tachyarrhythmia | Cardiac disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Tinnitus | Ear and labyrinth disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Accommodation disorder | Eye disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Diplopia | Eye disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Sudden visual loss | Eye disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Visual acuity reduced | Eye disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Abdominal wall haematoma | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Anal haemorrhage | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Cheilitis | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Enterocolitis | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Functional gastrointestinal disorder | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Gastric ulcer | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Gastroduodenitis | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Gastrointestinal angiodysplasia | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Haematochezia | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Melaena | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Oesophagitis | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Adverse drug reaction | General disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Localised oedema | General disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Thirst | General disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Hepatic cirrhosis | Hepatobiliary disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Erysipelas | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Gingivitis | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Onychomycosis | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Otitis media acute | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Pulpitis dental | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Pyuria | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Skin infection | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Tracheobronchitis | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Viral sinusitis | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment |
| |
| Epicondylitis | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment |
| |
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment |
| |
| Limb injury | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment |
| |
| Rib fracture | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA (20.1) | Systematic Assessment |
| |
| Blood creatinine abnormal | Investigations | MedDRA (20.1) | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA (20.1) | Systematic Assessment |
| |
| Blood iron decreased | Investigations | MedDRA (20.1) | Systematic Assessment |
| |
| Blood pressure abnormal | Investigations | MedDRA (20.1) | Systematic Assessment |
| |
| Blood pressure diastolic increased | Investigations | MedDRA (20.1) | Systematic Assessment |
| |
| Haemoglobin increased | Investigations | MedDRA (20.1) | Systematic Assessment |
| |
| N-terminal prohormone brain natriuretic peptide increased | Investigations | MedDRA (20.1) | Systematic Assessment |
| |
| Prostatic specific antigen increased | Investigations | MedDRA (20.1) | Systematic Assessment |
| |
| Vitamin B12 decreased | Investigations | MedDRA (20.1) | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA (20.1) | Systematic Assessment |
| |
| Weight increased | Investigations | MedDRA (20.1) | Systematic Assessment |
| |
| Diabetic metabolic decompensation | Metabolism and nutrition disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Dyslipidaemia | Metabolism and nutrition disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Gout | Metabolism and nutrition disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Obesity | Metabolism and nutrition disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Type 2 diabetes mellitus | Metabolism and nutrition disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Cervical spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Gouty arthritis | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Joint range of motion decreased | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Osteitis | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Osteoporosis | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Rotator cuff syndrome | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Spinal pain | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Temporomandibular joint syndrome | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Tendon disorder | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Tendonitis | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Torticollis | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (20.1) | Systematic Assessment |
| |
| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (20.1) | Systematic Assessment |
| |
| Carotid artery stenosis | Nervous system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Cervical radiculopathy | Nervous system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Leukoencephalopathy | Nervous system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Anxiety disorder | Psychiatric disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Bipolar disorder | Psychiatric disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Hallucination, visual | Psychiatric disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Nightmare | Psychiatric disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Chronic kidney disease | Renal and urinary disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Nephropathy | Renal and urinary disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Nocturia | Renal and urinary disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Pollakiuria | Renal and urinary disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Renal colic | Renal and urinary disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Bronchiectasis | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Catarrh | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Chronic respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Dyspnoea at rest | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Dyspnoea paroxysmal nocturnal | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Nocturnal dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Orthopnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Rales | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Blister | Skin and subcutaneous tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Decubitus ulcer | Skin and subcutaneous tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Ingrowing nail | Skin and subcutaneous tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Cataract operation | Surgical and medical procedures | MedDRA (20.1) | Systematic Assessment |
| |
| Coronary angioplasty | Surgical and medical procedures | MedDRA (20.1) | Systematic Assessment |
| |
| Dental operation | Surgical and medical procedures | MedDRA (20.1) | Systematic Assessment |
| |
| Intraocular lens implant | Surgical and medical procedures | MedDRA (20.1) | Systematic Assessment |
| |
| Aortic aneurysm | Vascular disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Peripheral arterial occlusive disease | Vascular disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Peripheral vascular disorder | Vascular disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Thrombophlebitis | Vascular disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Varicose vein | Vascular disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Venous thrombosis | Vascular disorders | MedDRA (20.1) | Systematic Assessment |
|
The recruitment was to be regarded as completed once approx. 2400 patients had entered the prospective period. However it was decided by Novartis to terminate the study prematurely, in March 2018.
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | 862-778-8300 | Novartis.email@novartis.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 22, 2018 | Mar 21, 2019 | SAP_001.pdf |
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
Not provided
Not provided
| Physician Decision |
|
| Adverse Event |
|
| Death |
|
| Relocation |
|
| ≥75 years to <85 years |
|
| ≥85 years |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Patients missing LVEF values |
|
|
|
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| Diuretics - without mineral corticoid antagonists |
| |||||
| Beta blocking agents |
| |||||
| Agents acting on the renin-angiotensin system |
| |||||
| Diuretics - mineral corticoid antagonists |
| |||||
| Antithrombotic agents |
| |||||
| Cardiac therapy |
| |||||
| Lipid modifying agents |
| |||||
| Mineral supplements |
| |||||
| Calcium channel blockers |
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|
Patients who were considered clinically stable and with NT-proBNP levels > 600 pg/ml who were referred to a cardiologist at Visit 1 for evaluation were in the follow-up set. |
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