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| ID | Type | Description | Link |
|---|---|---|---|
| 2019-002946-19 | EudraCT Number |
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| Name | Class |
|---|---|
| Eli Lilly and Company | INDUSTRY |
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This is a study in adults who are in hospital for acute heart failure. The purpose of this study is to find out whether starting to take a medicine called empagliflozin soon after first being treated in hospital helps people with acute heart failure.
Participants are in the study for about 3 months. At the beginning, participants are still in hospital. Later, they visit the hospital about 3 times and get 1 phone call. Participants are put into 2 groups by chance. One group takes 1 empagliflozin tablet a day. The other group takes
1 placebo tablet a day. Placebo tablets look like empagliflozin tablets but do not contain any medicine. Empagliflozin belongs to a class of medicines known as SGLT-2 inhibitors. It is used to treat type 2 diabetes.
During the study, the doctors check whether participants have additional heart failure events like needing to go to the hospital again because of heart failure. The participants answer questions about how their heart failure affects their life. We then compare the results between the empagliflozin and placebo groups. The doctors also regularly check the general health of the participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Empagliflozin | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Empagliflozin | Drug | Film-coated tablet |
| |
| Placebo to Empagliflozin |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Pairwise Comparisons With Wins of Clinical Benefit, a Composite of Death, Number of Heart Failure Events (HFEs), Time to the First HFE and ≥5-point Difference in CfB in KCCQ-TSS After 90 Days of Treatment | Clinical benefit, a composite of death, number of HFEs, time to first HFE and change from baseline (CfB) in Kansas City Cardiomyopathy Questionnaire-Total Symptom Score (KCCQ-TSS) after 90 days of treatment. All patients randomised to empagliflozin are compared to all patients randomised to placebo within strata. For any two patients, a patient will win, i.e. achieve a better clinical outcome, as determined by assessing the following criteria sequentially, stopping when an advantage for either patient is shown:
The KCCQ-TSS ranges from 0 to 100, where a higher score reflects a better outcome. pct. = percentage | Up to 90 days. For KCCQ-TSS: at baseline and at day 90. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Improvement of at Least 10 Points in KCCQ-TSS After 90 Days of Treatment | Number of participants with improvement of at least 10 points in Kansas City Cardiomyopathy Questionnaire - Total Symptom Score (KCCQ-TSS) from baseline after 90 days of treatment. The Kansas City Cardiomyopathy Questionnaire is a self-administered questionnaire that includes 23 items that map to 7 domains: symptom frequency, symptom burden, symptom stability, physical limitations, social limitations, quality of life and self-efficacy. The symptom frequency and symptom burden domains are merged into the total symptom score. Scores are represented on a 0-to-100-point scale, where a higher score reflects a better health status. |
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Inclusion Criteria:
Currently hospitalised for the primary diagnosis of acute heart failure (de novo or decompensated chronic HF), regardless of ejection fraction (EF). Patients with a diagnosis of hospitalized heart failure must have HF symptoms at the time of hospital admission
Evidence of left ventricular ejection fraction (LVEF, either reduced or preserved EF) as per local reading preferably measured during current hospitalisation or in the 12 months prior to randomisation
Patients must be randomised after at least 24 hours and no later than 5 days after admission, as early as possible after stabilization and while still in hospital
Patients must fulfil the following stabilisation criteria (while in the hospital):
Elevated NT-proBNP ≥ 1600pg/mL or BNP ≥400 pg/mL according to the local lab, for patients without atrial fibrillation (AF); or elevated NT-proBNP ≥ 2400pg/mL or BNP ≥600 pg/mL for patients with AF, measured during the current hospitalization or in the 72 hours prior to hospital admission,. For patients treated with an angiotensin receptor neprilysin inhibitor (ARNI) in the previous 4 weeks prior to randomisation, only NT-proBNP values should be used
HF episode leading to hospitalisation must have been treated with a minimum single dose of 40 mg of i.v. furosemide (or equivalent i.v. loop diuretic defined as 20 mg of torasemide or 1 mg of bumetanide)
Further Inclusion Criteria Apply
Exclusion Criteria:
Cardiogenic shock
Current hospitalisation for acute heart failure primarily triggered by pulmonary embolism, cerebrovascular accident, or acute myocardial infarction (AMI)
Current hospitalisation for acute heart failure not caused primarily by intravascular volume overload;
Below interventions in the past 30 days prior to randomisation or planned during the study:
Acute coronary syndrome / myocardial infarction, stroke or transient ischemic attack (TIA) in the past 90 days prior to randomisation
Heart transplant recipient, or listed for heart transplant with expectation to receive a transplant during the course of this trial (according to investigator judgement), or planned for palliative care for HF, or currently using left ventricular assist device (LVAD) or intra-aortic balloon pump (IABP) or any other type of mechanical circulatory support, or patients on mechanical ventilation, or patients with planned inotropic support in an outpatient setting
Haemodynamically significant (severe) uncorrected primary cardiac valvular disease planned for surgery or intervention during the course of the study (note: secondary mitral regurgitation or tricuspid regurgitation due to dilated cardiomyopathy is not excluded unless planned for surgery or intervention during the course of the study)
Impaired renal function, defined as eGFR < 20 mL/min/1.73 m2 as measured during hospitalization (latest local lab measurement before randomisation) or requiring dialysis
Type 1 Diabetes Mellitus (T1DM)
History of ketoacidosis, including diabetic ketoacidosis (DKA)
Further Exclusion Criteria Apply
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Southern California | Los Angeles | California | 90033 | United States | ||
| Cedars-Sinai Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41793401 | Derived | Angermann CE, Gerhardt T, Blatchford JP, Biegus J, Collins SP, Kosiborod M, Ferreira JP, Nassif ME, Psotka MA, Tromp J, Kraus BJ, Ponikowski P, Teerlink JR, Voors AA. Empagliflozin in De Novo vs Acute Decompensated Chronic Heart Failure: A Prespecified Analysis From EMPULSE. JACC Heart Fail. 2026 Mar 6:102999. doi: 10.1016/j.jchf.2026.102999. Online ahead of print. | |
| 40526444 |
| Label | URL |
|---|---|
| Related Info | View source |
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After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement".
Also, Researchers can use the following link https://www.mystudywindow.com/msw/datasharing to find information in order to request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.
The data shared are the raw clinical study data sets.
After all regulatory activities are completed in the US and EU for the product and indication, and after the primary manuscript has been accepted for publication.
For study documents - upon signing of a 'Document Sharing Agreement'. For study data - 1. after the submission and approval of the research proposal (checks will be performed by both the independent review panel and the sponsor, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a 'Data Sharing Agreement'.
All subjects were screened for eligibility prior to participation in the trial. Subjects attended a specialist site which ensured that they (the subjects) strictly met all inclusion and none of the exclusion criteria. Subjects were not to be allocated to a treatment group if any of the entry criteria were violated.
A multicentre, randomised, double-blind trial to assess whether in-hospital administration of empagliflozin results in improvement in heart failure-related outcomes compared to placebo in patients with acute heart failure.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | 1 film-coated tablet of placebo matching 10 mg empagliflozin was administered orally once daily in patients with acute heart failure. |
| FG001 | 10 mg Empagliflozin | 1 film-coated tablet of 10 milligram (mg) of empagliflozin was administered orally once daily in patients with acute heart failure. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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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 | Jun 4, 2020 | May 9, 2022 |
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| Drug |
Film-coated tablet |
|
| At baseline and at day 90. |
| Change From Baseline in KCCQ-TSS After 90 Days of Treatment | Change from baseline in Kansas City Cardiomyopathy Questionnaire - Total Symptom Score (KCCQ-TSS). The Kansas City Cardiomyopathy Questionnaire is a self-administered questionnaire that includes 23 items that map to 7 domains: symptom frequency, symptom burden, symptom stability, physical limitations, social limitations, quality of life and self-efficacy. The symptom frequency and symptom burden domains are merged into the total symptom score. The score is represented on a 0-to-100-point scale, where a higher score reflects a better health status. Change from baseline in KCCQ-TSS at day 90 was modeled using a MMRM with visit (day 15 and day 30) as repeated measures, adjusted mean (standard error) after 90 days of treatment is reported. | At baseline, at day 15, 30 and at day 90. |
| Change From Baseline in Log-transformed N-Terminal Pro-Brain Natriuretic Peptide (NTproBNP) Area Under the Curve (AUC) Over 30 Days of Treatment | Change from baseline in log-transformed N-Terminal Pro-Brain Natriuretic Peptide (NTproBNP) Area under the curve (AUC) over 30 days of treatment is reported. | From baseline to day 30. |
| Percentage of Days Alive and Out of Hospital (DAOH) From Study Drug Initiation Until 30 Days After Initial Hospital Discharge | The follow-up time for DAOH analyses was defined as 30 days after initial hospital discharge, or time between initial hospital discharge and date of censoring for non-fatal events except for patients who died within the first 30 days, where 30 days was considered as the DAOH follow-up time. DAOH for each patient was calculated as follow-up time subtracted by the number of days in hospital during the 30 days after initial hospital discharge as well as the number of days being dead within the 30 days. Percentage DAOH was defined as DAOH divided by the DAOH follow-up time of each patient multiplied by 100. | Up to 30 days after initial hospital discharge. |
| Percentage of Days Alive and Out of Hospital (DAOH) From Study Drug Initiation Until 90 Days After Randomisation | The follow-up time for DAOH analyses was defined as 90 days after randomisation, or time between randomisation and date of censoring for non-fatal events except for patients who died within the first 90 days, where 90 days was considered as the DAOH follow-up time. DAOH for each patient was calculated as follow-up time subtracted by the number of days in hospital during the 90 days after randomisation as well as the number of days being dead within the first 90 days. Percentage DAOH was defined as DAOH divided by the DAOH follow-up time of each patient multiplied by 100. | Up to 90 days after randomisation. |
| Incidence Rate of First Occurrence of Cardiovascular (CV) Death or Heart Failure Event (HFE) Until End of Trial Visit | Incidence rate of first occurrence of CV death or HFE until end of trial visit per 100 patient-year (pt-yrs) at risk is reported. Incidence rate per 100 pt-yrs = 100* number of patients with event / time at risk [years]. | Up to 127 days. |
| Number of Participants With Hospitalization for Heart Failure (HHF) Until 30 Days After Initial Hospital Discharge | Number of participants with hospitalization for heart failure (HHF) until 30 days after initial hospital discharge. | Up to 30 days after initial hospital discharge. |
| Composite Renal Endpoint: Number of Participants With Chronic Dialysis, Renal Transplant, Sustained Reduction in eGFR(CKD-EPI)cr | The occurrence of the composite renal endpoint:
Sustained was determined by 2 or more consecutive post-baseline central laboratory measurements separated by at least 30 days. | Up to 90 days. |
| Weight Change Per Mean Daily Loop Diuretic Dose After 15 Days of Treatment | Diuretic effect as assessed by weight change per mean daily loop diuretic dose after 15 days of treatment. Diuretic dose = 40 mg intravenous furosemide or 80 mg oral furosemide. Abbreviation: Kg: Kilogram | At baseline and at day 15. |
| Weight Change Per Mean Daily Loop Diuretic Dose After 30 Days of Treatment | Diuretic effect as assessed by weight change per mean daily loop diuretic dose after 30 days of treatment. Diuretic dose = 40 mg intravenous furosemide or 80 mg oral furosemide Abbreviation: Kg: Kilogram | At baseline and at day 30. |
| Los Angeles |
| California |
| 90048 |
| United States |
| University of California Irvine | Orange | California | 92865 | United States |
| The Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center | Torrance | California | 90502 | United States |
| Cardiology Associates Research Co. | Daytona Beach | Florida | 32117 | United States |
| University of Florida Health Jacksonville | Jacksonville | Florida | 32209 | United States |
| Grady Memorial Hospital | Atlanta | Georgia | 30303 | United States |
| Methodist Medical Center | Peoria | Illinois | 61603 | United States |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
| United Hospital | Saint Paul | Minnesota | 55102 | United States |
| University Of Mississippi Medical Center | Jackson | Mississippi | 39216-4505 | United States |
| Saint Luke's Hospital of Kansas City | Kansas City | Missouri | 64111 | United States |
| University of Nebraska Medical Center | Omaha | Nebraska | 68198 | United States |
| Cardiovascular Associates of the Delaware Valley | Elmer | New Jersey | 08318 | United States |
| Jefferson Washington Township Hospital | Washington Township | New Jersey | 08080 | United States |
| Erie County Medical Center | Buffalo | New York | 14215 | United States |
| The DeMatteis Center for Cardiac Research and Education | Greenvale | New York | 11548 | United States |
| Stony Brook Medicine | Stony Brook | New York | 11794 | United States |
| Montefiore Medical Center | The Bronx | New York | 10467 | United States |
| The University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | 27599 | United States |
| North Carolina Heart and Vascular | Raleigh | North Carolina | 27607 | United States |
| University of Oklahoma | Oklahoma City | Oklahoma | 73104 | United States |
| South Oklahoma Heart Research Group | Oklahoma City | Oklahoma | 73135 | United States |
| Ralph H. Johnson VA Medical Center | Charleston | South Carolina | 29401 | United States |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | United States |
| Pharmatex Research | Amarillo | Texas | 79109 | United States |
| Center for Advanced Cardiac Care - Heart Failure Clinic | Plano | Texas | 75093 | United States |
| Inova Fairfax Medical Campus | Falls Church | Virginia | 22042 | United States |
| Sentara Norfolk General Hospital | Norfolk | Virginia | 23507 | United States |
| University of Wisconsin | Madison | Wisconsin | 53792 | United States |
| Aalst - HOSP Onze-Lieve-Vrouw | Aalst | 9300 | Belgium |
| Brussels - UNIV UZ Brussel | Brussels | 1090 | Belgium |
| AZ Sint-Blasius | Dendermonde | 9200 | Belgium |
| Ziekenhuis Oost-Limburg - Campus Sint-Jan | Genk | 3600 | Belgium |
| UZ Leuven | Leuven | 3000 | Belgium |
| Liège - HOSP CHR de la Citadelle | Liège | 4000 | Belgium |
| UNIV Ambroise Paré | Mons | 7000 | Belgium |
| Royal Jubilee Hospital | Victoria | British Columbia | V8R 1J8 | Canada |
| St. Boniface General Hospital | Winnipeg | Manitoba | R2H 2A6 | Canada |
| Toronto General Hospital | Toronto | Ontario | M5G 2C4 | Canada |
| Beijing Chao-Yang Hospital | Beijing | 100020 | China |
| Beijing AnZhen Hospital | Beijing | 100029 | China |
| The First Hospital of Jilin University | Changchun | 130021 | China |
| West China Hospital | Chengdu | 610041 | China |
| First Affiliated Hospital of Xi'an JiaoTong University | Xi'an | 710061 | China |
| Xiamen Cardiovascular Hospital Xiamen University | Xiamen | 361004 | China |
| University Hospital Brno | Brno | 639 00 | Czechia |
| Univ.Hosp U Svate Anny, I.Internal Clinic-Cardiology,Brno | Brno | 65691 | Czechia |
| University Hospital Motol | Prague | 15006 | Czechia |
| District Hospital, Tabor | Tábor | 390 03 | Czechia |
| Aalborg Universitetsshospital | Aalborg | 9000 | Denmark |
| Frederiksberg Hospital | Frederiksberg | 2000 | Denmark |
| Herlev and Gentofte Hospital | Herlev | 2733 | Denmark |
| Hvidovre Hospital | Hvidovre | 2650 | Denmark |
| Viborg Regionhospital | Viborg | 8800 | Denmark |
| Charité - Universitätsmedizin Berlin | Berlin | 12203 | Germany |
| Bremer Institut für Herz- und Kreislaufforschung (BIHKF) am Klinikum Links der Weser | Bremen | 28277 | Germany |
| Herzzentrum Dresden GmbH Universitätsklinik | Dresden | 01307 | Germany |
| Universitäts-Herzzentrum Freiburg, Bad Krozingen GmbH | Freiburg im Breisgau | 79106 | Germany |
| Universitätsklinikum Gießen und Marburg GmbH | Giessen | 35392 | Germany |
| Universitätsklinikum Jena | Jena | 07743 | Germany |
| Asklepios Klinik Langen-Seligenstadt GmbH | Langen | 63225 | Germany |
| Klinikum Leverkusen gGmbH, Leverkusen | Leverkusen | 51375 | Germany |
| Klinikum der Stadt Ludwigshafen am Rhein gGmbH | Ludwigshafen | 67063 | Germany |
| Universitätsklinikum Schleswig-Holstein, Campus Lübeck | Lübeck | 23538 | Germany |
| Universitätsklinikum Würzburg AÖR | Würzburg | 97080 | Germany |
| Semmelweis University | Budapest | 1088 | Hungary |
| University Debrecen Hospital | Debrecen | 4032 | Hungary |
| University of Pecs | Pécs | 7624 | Hungary |
| Csongrad Country Dr Bugyi Istvan Hosp. | Szentes | 6600 | Hungary |
| Fejer County Saint George University Teaching Hospital | Székesfehérvár | 8000 | Hungary |
| ASST degli Spedali Civili di Brescia | Brescia | 25123 | Italy |
| Università degli Studi "Magna Grecia" - Campus "S. Venuta" | Catanzaro | 88100 | Italy |
| Ospedale della Val di Chiana Santa Margherita | Cortona | 52040 | Italy |
| Az.Osp. Universitaria "Ospedali Riuniti" | Foggia | 71100 | Italy |
| Centro Cardiologico Monzino-IRCCS | Milan | 20138 | Italy |
| ASST Grande Ospedale Metropolitano Niguarda | Milan | 20162 | Italy |
| Osp. Guglielmo da Saliceto AUSL di Piacenza | Piacenza | 29121 | Italy |
| IRCCS San Raffaele | Roma | 00163 | Italy |
| AO Città della Salute e della | Torino | 10126 | Italy |
| Azienda Sanitaria Universitaria Giuliano Isontina | Trieste | 34124 | Italy |
| Japan Community Health Care Organization Kyushu Hospital | Fukuoka, Kitakyushu | 806-8501 | Japan |
| Mito Medical Center | Ibaraki, Higashiibaraki-gun | 311-3193 | Japan |
| Kanagawa Cardiovascular and Respiratory Center | Kanagawa, Yokohama | 236-0051 | Japan |
| Shinshu University Hospital | Nagano, Matsumoto | 390-8621 | Japan |
| The Sakakibara Heart Institute of Okayama | Okayama, Okayama | 700-0804 | Japan |
| Osaka University Hospital | Osaka, Suita | 565-0871 | Japan |
| Kawaguchi Cardiovascular and Respiratory Hospital | Saitama, Kawaguchi | 333-0842 | Japan |
| Saitama Sekishikai Hospital | Saitama, Sayama | 350-1305 | Japan |
| Nihon University Itabashi Hospital | Tokyo, Itabashi-ku | 173-8610 | Japan |
| Jeroen Bosch Ziekenhuis-Hertogenbosch | 's-Hertogenbosch | 5223 GZ | Netherlands |
| Gelre Ziekenhuizen Apeldoorn | Apeldoorn | 7334 DZ | Netherlands |
| TREANT Zorggroep | Emmen | 7824 AA | Netherlands |
| Groene Hart ziekenhuis | Gouda | 2803 HH | Netherlands |
| Universitair Medisch Centrum Groningen | Groningen | 9713 GZ | Netherlands |
| Sint Jansdal Ziekenhuis | Harderwijk | 3844 DG | Netherlands |
| Alrijne Leiderdorp | Leiderdorp | 2353 GA | Netherlands |
| Bravis ziekenhuis, locatie Roosendaal | Roosendaal | 4708 AE | Netherlands |
| HagaZiekenhuis | The Hague | 2545 AA | Netherlands |
| Diakonessenhuis Utrecht | Utrecht | 3582 KE | Netherlands |
| Helse Førde HF, Førde Sentralsjukehus | Førde | N-6812 | Norway |
| Sykehuset Innlandet HF, Avd. Lillehammer | Lillehammer | N-2609 | Norway |
| Akershus Universitetssykehus HF | Lørenskog | N-1478 | Norway |
| Helse Stavanger, Stavanger Universitetssykehus | Stavanger | N-4011 | Norway |
| Universitetssykehuset Nord-Norge, Tromsø | Tromsø | N-9019 | Norway |
| Saint Wincenty a Paulo Hosp., Cardiology Dept., Gdynia | Gdynia | 81348 | Poland |
| Card.Cli.Mil.Med.Ac.Uni.Cli.Hosp. Cent.Vetera.Hosp.Lodz | Lodz | 90549 | Poland |
| Cent.Clin.Hosp.Med.Univ.Lodz,Electrocard | Lodz | 92-213 | Poland |
| Provincial Specialist M. Kopernik Hospital | Lodz | 93-513 | Poland |
| Hospital Universitario Virgen de la Arrixaca | El Palmar | 30120 | Spain |
| Hospital de Bellvitge | L'Hospitalet de Llobregat | 08907 | Spain |
| Hospital Puerta de Hierro | Majadahonda | 28222 | Spain |
| Hospital Virgen de la Victoria | Málaga | 29010 | Spain |
| Hospital Moises Broggi | Sant Joan Despí | 08970 | Spain |
| Hospital Nuestra Señora de Valme | Seville | 41014 | Spain |
| Hospital Clínico de Valencia | Valencia | 46010 | Spain |
| Sahlgrenska US, Göteborg | Gothenburg | 41345 | Sweden |
| Sahlgrenska Universitetssjukhuset, Östra | Gothenburg | 416 85 | Sweden |
| Jongs N, Gasparyan SB, Frison L, Schloemer P, Brinker M, Little DJ, Heerspink HJL. Use of eGFR Slope Thresholds as End Point Components in a Kidney Disease Progression Hierarchical Composite End Point. J Am Soc Nephrol. 2025 Dec 1;36(12):2421-2430. doi: 10.1681/ASN.0000000766. Epub 2025 Jun 17. |
| 37540060 | Derived | Ferreira JP, Blatchford JP, Teerlink JR, Kosiborod MN, Angermann CE, Biegus J, Collins SP, Tromp J, Nassif ME, Psotka MA, Comin-Colet J, Mentz RJ, Brueckmann M, Nordaby M, Ponikowski P, Voors AA. Mineralocorticoid receptor antagonist use and the effects of empagliflozin on clinical outcomes in patients admitted for acute heart failure: Findings from EMPULSE. Eur J Heart Fail. 2023 Oct;25(10):1797-1805. doi: 10.1002/ejhf.2982. Epub 2023 Aug 22. |
| 35377706 | Derived | Kosiborod MN, Angermann CE, Collins SP, Teerlink JR, Ponikowski P, Biegus J, Comin-Colet J, Ferreira JP, Mentz RJ, Nassif ME, Psotka MA, Tromp J, Brueckmann M, Blatchford JP, Salsali A, Voors AA. Effects of Empagliflozin on Symptoms, Physical Limitations, and Quality of Life in Patients Hospitalized for Acute Heart Failure: Results From the EMPULSE Trial. Circulation. 2022 Jul 26;146(4):279-288. doi: 10.1161/CIRCULATIONAHA.122.059725. Epub 2022 Apr 4. |
| 35228754 | Derived | Voors AA, Angermann CE, Teerlink JR, Collins SP, Kosiborod M, Biegus J, Ferreira JP, Nassif ME, Psotka MA, Tromp J, Borleffs CJW, Ma C, Comin-Colet J, Fu M, Janssens SP, Kiss RG, Mentz RJ, Sakata Y, Schirmer H, Schou M, Schulze PC, Spinarova L, Volterrani M, Wranicz JK, Zeymer U, Zieroth S, Brueckmann M, Blatchford JP, Salsali A, Ponikowski P. The SGLT2 inhibitor empagliflozin in patients hospitalized for acute heart failure: a multinational randomized trial. Nat Med. 2022 Mar;28(3):568-574. doi: 10.1038/s41591-021-01659-1. Epub 2022 Feb 28. |
| Treated |
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| COMPLETED |
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| NOT COMPLETED |
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|
Randomised Set (RS), including all randomised patients.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | 1 film-coated tablet of placebo matching 10 mg empagliflozin was administered orally once daily in patients with acute heart failure. |
| BG001 | 10 mg Empagliflozin | 1 film-coated tablet of 10 milligram (mg) of empagliflozin was administered orally once daily in patients with acute heart failure. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Kansas City cardiomyopathy questionnaire-Total symptom score (KCCQ-TSS) | The Kansas City Cardiomyopathy Questionnaire is a self-administered questionnaire that includes 23 items that map to 7 domains: symptom frequency, symptom burden, symptom stability, physical limitations, social limitations, quality of life and self-efficacy. The symptom frequency and symptom burden domains are merged into a total symptom score. Scores are represented on a 0-to-100-point scale, where a higher score reflects a better health status. KCCQ-TSS at baseline is reported. Only participants in the randomised set and with non-missing data are included. | Only participants in the randomised set and with non-missing data are included. | Mean | Standard Deviation | Score on a scale |
|
| 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 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Pairwise Comparisons With Wins of Clinical Benefit, a Composite of Death, Number of Heart Failure Events (HFEs), Time to the First HFE and ≥5-point Difference in CfB in KCCQ-TSS After 90 Days of Treatment | Clinical benefit, a composite of death, number of HFEs, time to first HFE and change from baseline (CfB) in Kansas City Cardiomyopathy Questionnaire-Total Symptom Score (KCCQ-TSS) after 90 days of treatment. All patients randomised to empagliflozin are compared to all patients randomised to placebo within strata. For any two patients, a patient will win, i.e. achieve a better clinical outcome, as determined by assessing the following criteria sequentially, stopping when an advantage for either patient is shown:
The KCCQ-TSS ranges from 0 to 100, where a higher score reflects a better outcome. pct. = percentage | Randomised Set (RS), including all randomised patients. | Posted | Number | pct. (%) of winning pairwise comparisons | Up to 90 days. For KCCQ-TSS: at baseline and at day 90. | Pairwise comparisons | Pairwise comparisons |
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| Secondary | Number of Participants With Improvement of at Least 10 Points in KCCQ-TSS After 90 Days of Treatment | Number of participants with improvement of at least 10 points in Kansas City Cardiomyopathy Questionnaire - Total Symptom Score (KCCQ-TSS) from baseline after 90 days of treatment. The Kansas City Cardiomyopathy Questionnaire is a self-administered questionnaire that includes 23 items that map to 7 domains: symptom frequency, symptom burden, symptom stability, physical limitations, social limitations, quality of life and self-efficacy. The symptom frequency and symptom burden domains are merged into the total symptom score. Scores are represented on a 0-to-100-point scale, where a higher score reflects a better health status. | Randomised Set (RS), including all randomised patients. | Posted | Count of Participants | Participants | At baseline and at day 90. |
|
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| Secondary | Change From Baseline in KCCQ-TSS After 90 Days of Treatment | Change from baseline in Kansas City Cardiomyopathy Questionnaire - Total Symptom Score (KCCQ-TSS). The Kansas City Cardiomyopathy Questionnaire is a self-administered questionnaire that includes 23 items that map to 7 domains: symptom frequency, symptom burden, symptom stability, physical limitations, social limitations, quality of life and self-efficacy. The symptom frequency and symptom burden domains are merged into the total symptom score. The score is represented on a 0-to-100-point scale, where a higher score reflects a better health status. Change from baseline in KCCQ-TSS at day 90 was modeled using a MMRM with visit (day 15 and day 30) as repeated measures, adjusted mean (standard error) after 90 days of treatment is reported. | Patients in the randomised set (RS) and with non-missing data for this endpoint. Observed case including data after treatment discontinuation (OC-AD). | Posted | Least Squares Mean | Standard Error | Score on a scale | At baseline, at day 15, 30 and at day 90. |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Log-transformed N-Terminal Pro-Brain Natriuretic Peptide (NTproBNP) Area Under the Curve (AUC) Over 30 Days of Treatment | Change from baseline in log-transformed N-Terminal Pro-Brain Natriuretic Peptide (NTproBNP) Area under the curve (AUC) over 30 days of treatment is reported. | Patients included the randomised set (RS), and with non-missing data for this endpoint. | Posted | Geometric Least Squares Mean | 95% Confidence Interval | Picogram/milliliter * days | From baseline to day 30. |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Days Alive and Out of Hospital (DAOH) From Study Drug Initiation Until 30 Days After Initial Hospital Discharge | The follow-up time for DAOH analyses was defined as 30 days after initial hospital discharge, or time between initial hospital discharge and date of censoring for non-fatal events except for patients who died within the first 30 days, where 30 days was considered as the DAOH follow-up time. DAOH for each patient was calculated as follow-up time subtracted by the number of days in hospital during the 30 days after initial hospital discharge as well as the number of days being dead within the 30 days. Percentage DAOH was defined as DAOH divided by the DAOH follow-up time of each patient multiplied by 100. | Patients included the treated set (TS), and with non-missing data for this endpoint. TS includes all patients treated with at least one dose of trial medication. | Posted | Mean | Standard Deviation | DAOH in percentage (%) | Up to 30 days after initial hospital discharge. |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Days Alive and Out of Hospital (DAOH) From Study Drug Initiation Until 90 Days After Randomisation | The follow-up time for DAOH analyses was defined as 90 days after randomisation, or time between randomisation and date of censoring for non-fatal events except for patients who died within the first 90 days, where 90 days was considered as the DAOH follow-up time. DAOH for each patient was calculated as follow-up time subtracted by the number of days in hospital during the 90 days after randomisation as well as the number of days being dead within the first 90 days. Percentage DAOH was defined as DAOH divided by the DAOH follow-up time of each patient multiplied by 100. | Patients in the treated set (TS) and with non-missing data for this endpoint. | Posted | Mean | Standard Deviation | DAOH in percentage (%) | Up to 90 days after randomisation. |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Incidence Rate of First Occurrence of Cardiovascular (CV) Death or Heart Failure Event (HFE) Until End of Trial Visit | Incidence rate of first occurrence of CV death or HFE until end of trial visit per 100 patient-year (pt-yrs) at risk is reported. Incidence rate per 100 pt-yrs = 100* number of patients with event / time at risk [years]. | Randomised Set (RS), including all randomised patients. | Posted | Number | 95% Confidence Interval | Patients with events / 100pt-yrs at risk | Up to 127 days. |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Hospitalization for Heart Failure (HHF) Until 30 Days After Initial Hospital Discharge | Number of participants with hospitalization for heart failure (HHF) until 30 days after initial hospital discharge. | Randomised Set (RS), including all randomised patients. | Posted | Count of Participants | Participants | Up to 30 days after initial hospital discharge. |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Composite Renal Endpoint: Number of Participants With Chronic Dialysis, Renal Transplant, Sustained Reduction in eGFR(CKD-EPI)cr | The occurrence of the composite renal endpoint:
Sustained was determined by 2 or more consecutive post-baseline central laboratory measurements separated by at least 30 days. | Randomised Set (RS), including all randomised patients. | Posted | Count of Participants | Participants | Up to 90 days. |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Weight Change Per Mean Daily Loop Diuretic Dose After 15 Days of Treatment | Diuretic effect as assessed by weight change per mean daily loop diuretic dose after 15 days of treatment. Diuretic dose = 40 mg intravenous furosemide or 80 mg oral furosemide. Abbreviation: Kg: Kilogram | Patients in the randomised set (RS) and with non-missing values for this endpoint. | Posted | Mean | Standard Deviation | Kg per loop diuretic dose | At baseline and at day 15. |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Weight Change Per Mean Daily Loop Diuretic Dose After 30 Days of Treatment | Diuretic effect as assessed by weight change per mean daily loop diuretic dose after 30 days of treatment. Diuretic dose = 40 mg intravenous furosemide or 80 mg oral furosemide Abbreviation: Kg: Kilogram | Patients in the randomised set (RS) and with non-missing values for this endpoint. | Posted | Mean | Standard Deviation | Kg per loop diuretic dose | At baseline and at day 30. |
|
|
[All-cause Mortality]: From first study drug intake until end of follow-up, up to 202 days. [Serious and Other Adverse Event]: From first study drug intake until 7 days after last intake of study medication, up to 127 days.
[All-cause Mortality]: Randomised Set (RS) including all randomised patients. [Serious and Other Adverse Events]: Treated Set (TS), consisting of all patients treated with at least once dose of trial medication.
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 | Placebo | 1 film-coated tablet of placebo matching 10 mg empagliflozin was administered orally once daily in patients with acute heart failure. | 22 | 265 | 115 | 264 | 19 | 264 |
| EG001 | 10 mg Empagliflozin | 1 film-coated tablet of 10 milligram (mg) of empagliflozin was administered orally once daily in patients with acute heart failure. | 11 | 265 | 84 | 260 | 20 | 260 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute left ventricular failure | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Aortic valve incompetence | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Atrial flutter | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Atrial thrombosis | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Cardiac failure acute | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Cardiac failure chronic | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Cardiac ventricular thrombosis | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Cardiogenic shock | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Chronic left ventricular failure | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Coronary artery occlusion | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Coronary artery stenosis | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Coronary ostial stenosis | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Mitral valve incompetence | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Myocardial ischaemia | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Silent myocardial infarction | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Sinus node dysfunction | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Ventricular arrhythmia | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Ventricular fibrillation | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Ventricular tachycardia | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Gastrointestinal arteriovenous malformation | Congenital, familial and genetic disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Deafness | Ear and labyrinth disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Colitis ischaemic | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Intestinal ischaemia | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Mesenteric arteriosclerosis | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Obstructive pancreatitis | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Death | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Multiple organ dysfunction syndrome | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Sudden cardiac death | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Vascular stent stenosis | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Acute hepatic failure | Hepatobiliary disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Congestive hepatopathy | Hepatobiliary disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Hepatic cirrhosis | Hepatobiliary disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Hepatotoxicity | Hepatobiliary disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Bacterial infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| COVID-19 pneumonia | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Erysipelas | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Hepatitis A | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Infectious pleural effusion | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Infective exacerbation of chronic obstructive airways disease | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Intervertebral discitis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Klebsiella infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Pelvic abscess | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Pulmonary sepsis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Staphylococcal bacteraemia | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Subcutaneous abscess | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Urinary tract infection bacterial | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Cervical vertebral fracture | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| Dislocation of vertebra | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| Eye injury | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| Fibula fracture | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| Head injury | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| Tibia fracture | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| Vascular pseudoaneurysm | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| Blood urea increased | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| Blood uric acid increased | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| Glomerular filtration rate decreased | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| International normalised ratio increased | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| Troponin increased | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Electrolyte imbalance | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Gout | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Metabolic acidosis | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Lung adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
| |
| Meningioma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
| |
| Metastases to bone | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
| |
| Metastatic neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
| |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
| |
| Prostate cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
| |
| Carotid artery dissection | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Carotid artery occlusion | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Cauda equina syndrome | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Monoplegia | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Paraplegia | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Speech disorder | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Spinal cord compression | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Toxic encephalopathy | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Delirium | Psychiatric disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Mental status changes | Psychiatric disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Suicide attempt | Psychiatric disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Chronic kidney disease | Renal and urinary disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Hydronephrosis | Renal and urinary disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Nephropathy | Renal and urinary disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Nephrotic syndrome | Renal and urinary disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Renal artery stenosis | Renal and urinary disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Renal impairment | Renal and urinary disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Acute pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Haemothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Pulmonary hypertension | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Extremity necrosis | Vascular disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Hypertensive crisis | Vascular disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Hypertensive emergency | Vascular disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Hypovolaemic shock | Vascular disorders | MedDRA 24.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypotension | Vascular disorders | MedDRA 24.0 | Systematic Assessment |
|
Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim, Call Centre | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 11, 2021 | May 9, 2022 | SAP_001.pdf |
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C570240 | empagliflozin |
Not provided
Not provided
Not provided
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