Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Carlos III Health Institute | OTHER_GOV |
| Basque Health Service | OTHER_GOV |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Introduction: Heart Failure (HF) generates multiple hospital admissions and mortality, which are reduced with the administration of Beta-Blocker (BB), Angiotensin Converting Enzyme Inhibitor (ACEI), Angiotensin II Receptor Blocker (ARB) and Mineralocorticoid Receptor Antagonist (MRA) drugs (Level of Evidence A). The effect is dose-dependent. Nevertheless, dosages are suboptimal. European Guidelines 2012 recommend close monitoring and up-titration of drugs by HF nurses. Trials are needed to evaluate their effectiveness and safety. Objective: To compare doses achieved by patients of BB, ACEI, ARB II and MRA in 4 months ( % relative to target doses) in the intervention group (HF nurse) and in the control group ( cardiologist), adverse events, Left Ventricular Ejection Fraction (LVEF), New York Heart Association (NYHA), 6 min. walking test, quality of life, Nt-proBNP, readmissions and mortality. Hypothesis: Non-inferiority. Design: Multicenter randomized controlled trial. New ("de novo") HF patients with LVEF ≤ 40%, NYHA II-III, without contraindications to BB of 17 Spanish hospitals will be included. Intervention: The cardiologist prescribes drugs and, driven by protocol, the HF nurse implements the up-titration. In the control group doses are decided by the cardiologist clinical support and education being provided by nurses. Variables: age, sex, education, psycho-social level, Cardio Vascular Risk Factors (CVRF), NYHA, LVEF, ischemic cardiopathy., N-terminal pro B-type natriuretic peptide (Nt-proBNP), 6min. walking test, Creatinine/Glomerular Filtration Rate (GFR), Potassium (K), haemoglobin, Blood Pressure (BP), Heart Rate (HR), mg./drug, European Heart Failure Self-Care Behaviour Scale (EHFScBS), Minnesota Living with Heart Failure questionnaire (MLHFQ), European Quality of life Scale (EQ-5D). Expected Results: If our hypothesis were confirmed, evidence would be provided on the effectiveness of this healthcare management, that could be economically evaluated in future studies. A qualitative study also will be undertaken to explore barriers and facilitators to implementation
No apply
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Heart Failure (HF) cardiologist up-titration | Active Comparator | Active Comparator:Cardiologist decides dosage with nursing clinical and educational support. |
|
| HF nurse up-titration | Experimental | Intervention: The cardiologist prescribes drugs and, driven by protocol, the HF nurse implements the up-titration. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Heart Failure (HF) nurse up-titration | Other | Up-titration of Beta-Blocker (BB), Angiotensin Converting Enzyme Inhibitor (ACEI), Angiotensin II Receptor Blocker (ARB) and Mineralocorticoid Receptor Antagonist (MRA) in Heart Failure "De Novo" patients with Left Ventricular Ejection Fraction (LVEF)≤ 40%, following a protocol based on 2012 European Society of Cardiology (ESC) Heart Failure (HF) guidelines with cardiologist prescription and support. |
| Measure | Description | Time Frame |
|---|---|---|
| BB % Relative Dose (Mean) With Regard to Target Dose | BB mean Relative dose is the mean dose of betablockers achieved 4 months after starting titration, relative to target dose ( %) , which is the target dose of european heart failure guidelines for BB. | 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Worsening Renal Function (From Baseline to 4th Month) | Number of participants with worsening renal function during the titration process (from baseline to 4 month) that could be associated to the titration process (Creatinine increase >50% baseline creatinine or creatinine>3mg/dl, or Estimated Glomerular Filtration<25 ml/min/1.73 m2) | 4 months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Maria Juana Oyanguren, Nurse | Osakidetza-Servicio vasco de Salud | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital de usansolo-Galdakao | Usansolo | Bizkaia | 48960 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29154427 | Background | Oyanguren J, Garcia-Garrido L, Nebot Margalef M, Lekuona I, Comin-Colet J, Manito N, Roure J, Ruiz Rodriguez P, Enjuanes C, Latorre P, Torcal Laguna J, Garcia-Gutierrez S; ETIFIC7 research group. Design of a multicentre randomized controlled trial to assess the safety and efficacy of dose titration by specialized nurses in patients with heart failure. ETIFIC study protocol. ESC Heart Fail. 2017 Nov;4(4):507-519. doi: 10.1002/ehf2.12152. Epub 2017 Apr 3. | |
| 32591295 |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Heart Failure (HF) Nurse Up-titration | Intervention:The cardiologist prescribes drugs and the HF-nurse implements the up-titration, driven by protocol based on 2012 ESC HF guidelines, with cardiologist support. Up-titration of Beta-Blocker (BB), Angiotensin Converting Enzyme Inhibitor (ACEI), Angiotensin II Receptor Blocker (ARB) and Mineralocorticoid Receptor Antagonist (MRA) drugs of Heart Failure "De Novo" Left Ventricular Ejection Fraction ≤ 40% Patients |
| FG001 | Heart Failure (HF) Cardiologist Up-titration | Active Comparator:The cardiologist prescribes and decides dosage following a protocol based on 2012 ESC HF guidelines, with nursing clinical and educational support. Up-titration of Beta-Blocker (BB), Angiotensin Converting Enzyme Inhibitor (ACEI), Angiotensin II Receptor Blocker (ARB) and Mineralocorticoid Receptor Antagonist (MRA) drugs of Heart Failure "De Novo" Left Ventricular Ejection Fraction ≤ 40% Patients |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 4 Months Evaluation |
|
| |||||||||||||||||||||
| 6 Months Evaluation |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Heart Failure (HF) Cardiologist Up-titration | Active Comparator:Cardiologist decides dosage with nursing clinical and educational support. HF cardiologist up-titration: Up-titration of Beta-Blocker (BB) in Heart Failure " De Novo" Left Ventricular Ejection Fraction ≤ 40% Patients, following a protocol based on 2012 ESC HF guidelines HF cardiologist up-titration: Up-titration of Angiotensin Converting Enzyme Inhibitor (ACEI) in Heart Failure " De Novo" Left Ventricular Ejection Fraction ≤ 40% Patients, following a protocol based on 2012 ESC HF guidelines HF cardiologist up-titration: Up-titration of Angiotensin II Receptor Blocker (ARB) in Heart Failure " De Novo" Left Ventricular Ejection Fraction≤ 40% Patients, following a protocol based on 2012 ESC HF guidelines HF cardiologist up-titration: Up-titration of Mineralocorticoid Receptor Antagonist (MRA) in Heart Failure " De Novo" Left Ventricular Ejection Fraction ≤ 40% Patients, following a protocol based on 2012 ESC HF guidelines |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | BB % Relative Dose (Mean) With Regard to Target Dose | BB mean Relative dose is the mean dose of betablockers achieved 4 months after starting titration, relative to target dose ( %) , which is the target dose of european heart failure guidelines for BB. | Posted | Mean | Standard Deviation | percentage of target dose | 4 months |
|
From Baseline to 6 months
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 | Heart Failure (HF) Cardiologist Up-titration | Active Comparator:Cardiologist decides dosage with nursing clinical and educational support. HF cardiologist up-titration: Up-titration of Beta-Blocker (BB) in Heart Failure " De Novo" EF≤ 40% Patients, following a protocol based on 2012 ESC HF guidelines HF cardiologist up-titration: Up-titration of Angiotensin Converting Enzyme Inhibitor (ACEI) in Heart Failure " De Novo" EF≤ 40% Patients, following a protocol based on 2012 ESC HF guidelines HF cardiologist up-titration: Up-titration of Angiotensin II Receptor Blocker (ARB) in Heart Failure " De Novo" EF≤ 40% Patients, following a protocol based on 2012 ESC HF guidelines HF cardiologist up-titration: Up-titration of Mineralocorticoid Receptor Antagonist (MRA) in Heart Failure " De Novo" EF≤ 40% Patients, following a protocol based on 2012 ESC HF guidelines |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| hospitalizations due to cardiovascular cause | Cardiac disorders | Systematic Assessment | unplanned hospitalizations due to cardiovascular cause (not due to non cardiovascular cause) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| heart rate <50 bpm | Cardiac disorders | Systematic Assessment | heart rate < 50 bpm, bradycardia possibly due to the titration process |
the implementation of ETIFIC in a single country; its recruitment characteristics, inclusion of de novo HF patients exclusively, relatively young patients and the low percentage of women and patients with ischemic heart disease.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Juana Oyanguren, Nursing graduate, Master in Heart Failure, CV Pathology and Thrombosis Specialist | Servicio de Cardiologıa, Hospital Universitario Galdakao-Usansolo, OSI Barrualde-Galdakao-Osakidetza, Servicio Vasco de Salud, Galdakao, Bizkaia, Spain .BIOCRUCES, Instituto de Investigacion Sanitaria, Bizkaia, Spain | 34 656780945 |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 1, 2015 | Oct 16, 2020 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 1, 2015 | Oct 16, 2020 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Heart Failure (HF) cardiologist up-titration | Other | Up-titration of Beta-Blocker (BB), Angiotensin Converting Enzyme Inhibitor (ACEI), Angiotensin II Receptor Blocker (ARB) and Mineralocorticoid Receptor Antagonist (MRA) in Heart Failure "De Novo" patients with Left Ventricular Ejection Fraction (LVEF)≤ 40%, following a protocol based on 2012 European Society of Cardiology (ESC) Heart Failure (HF) guidelines. Drugs are prescribed and titrated by the cardiologist. |
|
| Number of Participants With Potassium (K) ≥5.5 Meq/l (From Baseline to 4 Month) | Number of participants with Potassium≥ 5.5 meq/l during the titration process (from baseline to 4 month) that could be associated to this titration process | 4 months |
| Number of Participants With Symptomatic Hypotension (From Baseline to 4 Month) | Description: Number of participants with symptomatic hypotension during the titration process (from baseline to 4 month) that could be associated to this titration process. Symptomatic hypotension defined as symptoms such as dizziness or light headedness, associated to hypotension | 4 months |
| Number of Participants With Heart Rate (HR) < 50 Beats Per Minute (From Baseline to 4 Month) | Number of participants with Heart Rate (HR) < 50 beats per minute during the titration process (from baseline to 4 month) , which could be associated to the titration process. (with or without symptoms) | 4 months |
| Number of Patients With Atrio Ventricular (AV) Block Due to Titration | Number of patients with AV Block during the titration process, associated to the BB titration | 4 months |
| Number of Patients With Worsening of Heart Failure Signs and Symptoms | Number of patients with worsening of heart failure signs and symptoms during the titration process ( from baseline to 4 month) which could be associated to the titration process. | 4 months |
| Number of Patients With Admissions Due to Titration | Number of patients with admissions due to titration ( not due to other causes) | 4 months |
| Number of Patients: Mortality Due to Titration | Number of patients: Mortality due to titration ( not due to other causes) | 4 months |
| Number of Paticipants With Drug Stop (Some Titration Drug Withdrawal Due to Intolerance, no Need or Change to Other Treatment) | number of paticipants with drug Stop ( withdrawal) that occur during the titration process that could be due to an adverse event. ( it can be not only due to an adverse event but because there is no need of this drug or its substitution for another kind of drug) | 4 months |
| Change in % Left Ventricular Ejection Fraction | Change in % Left Ventricular Ejection Fraction (difference of change from baseline to 6 months between groups) Ejection fraction is a measurement of the percentage of blood leaving the heart each time it contracts. | 6 months |
| N-terminal Pro-B Type Natriuretic Peptide Improvement (Nt-proBNP) | Nt-proBNP (N-terminal pro-B type natriuretic peptide) Improvement (Decrease) difference of change from baseline to 6 months between groups, mean (SD) | 6 months |
| 6 Minute Walking Test | 6 minute walking test improvement ( change) meters.Improvement (difference of change from baseline to 6 months between groups Six minute walking test. Measurement of exercise capacity is an integral element in assessment of patients with cardiopulmonary disease. It provides information regarding functional capacity, response to therapy and prognosis across a range of chronic cardiopulmonary conditions. The six-minute walk test (6MWT) measures the distance (meters) an individual is able to walk over a total of six minutes on a hard, flat surface. The goal is for the individual to walk as far as possible in six minutes. The individual is allowed to self-pace and rest as needed as they traverse back and forth along a marked walkway. | 6 months |
| Number of Participants n(%) in New York Heart Association Functional Classification I,II,III,IV | Number of participants class I-IV New York Heart Association (NYHA) functional classification, based on severity of symptoms and physical activity: NYHA I (better): No limitation of physical activity; NYHA II: Slight limitation of ordinary physical activity, breathlessness; NYHA III: marked limitation of physical activity. Comfortable at rest, but less than ordinary activity results in undue breathlessness, fatigue or palpitations; NYHA IV ( worse): unable to carry on any physical activity without discomfort.Symptoms at rest can be present. If any physical activity is undertaken discomfort is increased. | 6 months |
| Quality of Life: MLWHFQ | Quality of Life, measured by Minnesota Living with Heart Failure Questionnaire. Improvement (change) from baseline to 6 months. Minnesota Living With Heart Failure Questionnaire (MLWHFQ). The content of this questionnaire was selected to be representative of the ways heart failure and treatments can affect the key physical, emotional, social and mental dimensions of quality of life of patients with heart failure. It consist of 21-items with score 0-5. Final evaluation moves from 0 (none) to 105 (very much); a lower score means better quality of life. | 6 months |
| European Quality of Life Scale: EuroQol- 5 Dimension Index | European Quality of Life Scale: EuroQol- 5 Dimension index (Range: 1 full health-0 death). It measures health status self-reported by the patient. It has 5 domains: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension is divided into three levels: 1 no problem; 2 some or moderate problems; 3 extreme problems. The EuroQol Research Foundation converts this information into a single summary index, by applying a formula that attaches specific country values (called weights) to each of the levels in each dimension. The index is calculated by subtracting the mentioned weights from 1, the value for full health. We measured the EuroQol-5D index improvement (change) from baseline to 6 months. More information in: EQ-5D-3L-User-Guide_version-6.0 (1).pdf | 6 months |
| Number of Patients With Admissions Due to Heart Failure (HF) | Number of patients with hospital admissions due to Heart Failure. From Baseline to 6 months | 6 months |
| Number of Patients With Deaths | Number of Patients with deaths due to Cardiovascular and non cardiovascular causes | 6 months |
| ACEI % Relative Dose (Mean) With Regard to Target Dose | ACEI mean Relative dose is the mean dose of ACEI achieved 4 months after starting titration, relative to target dose (%) described in European guidelines | 4 Months |
| ARB % Relative Dose (Mean) With Regard to Target Dose | ARB, angiotensin II receptor blockers, mean relative dose ( % to target dose). Target dose is described in European guidelines. Measured at 4 months after starting titration. | 4 months |
| MRA % Relative Dose (Mean) With Regard to Target Dose | MRA % relative dose (mean) is the mean dose achieved 4 months after starting titration with regard to target dose (%) described in european guidelines | 4 months |
| Result |
| Oyanguren J, Garcia-Garrido L, Nebot-Margalef M, Latorre-Garcia P, Torcal-Laguna J, Comin-Colet J, Roure J, Gonzalez-Costello J, Manito N, Garcia-Pinilla JM, Sanchez-Paule Y, Varela-Roman A, Moure M, Segovia-Cubero J, Soria T, Arana-Arri E, Lekuona I; Steering Committee on behalf of the ETIFIC research team group. Noninferiority of heart failure nurse titration versus heart failure cardiologist titration. ETIFIC multicenter randomized trial. Rev Esp Cardiol (Engl Ed). 2021 Jun;74(6):533-543. doi: 10.1016/j.rec.2020.04.016. Epub 2020 Jun 24. English, Spanish. |
| 34903479 | Derived | Oyanguren J, Diaz-Molina B, Lekuona I, Gonzalez-Costello J, Lopez-Fernandez S, Garcia-Pinilla JM, Garcia-Garrido L, Lopez-Moyano G, Manito N, Cobo-Marcos M, Nebot-Margalef M, Latorre-Garcia P, Arana-Arri E, Perez-Fernandez S, Torcal-Laguna J; ETIFIC research team group. Gender differences in drug titration among heart failure patients with reduced ejection fraction in the ETIFIC trial. Rev Esp Cardiol (Engl Ed). 2022 Aug;75(8):636-648. doi: 10.1016/j.rec.2021.11.002. Epub 2021 Dec 10. English, Spanish. |
| Lost to Follow-up |
|
| Physician Decision |
|
| Working or living abroad |
|
| reasons not due to titration |
|
| HF Unit not active in summer |
|
| NOT COMPLETED |
|
|
| BG001 | HF Nurse Up-titration | Patients, following a protocol based on 2012 ESC HF guidelines. Cardiologist prescription and support HF nurse up-titration: Up-titration of Beta-Blocker (BB) in Heart Failure " De Novo" Left Ventricular Ejection Fraction ≤ 40% Patients, following a protocol based on 2012 ESC HF guidelines. HF nurse up-titration: Up-titration of Angiotensin Converting Enzyme Inhibitor (ACEI) in Heart Failure " De Novo" Left Ventricular Ejection Fraction ≤ 40% Patients, following a protocol based on 2012 ESC HF guidelines. HF nurse up-titration: Up-titration of Angiotensin II Receptor Blocker (ARB) in Heart Failure " De Novo" Left Ventricular Ejection Fraction ≤ 40% Patients. Protocol based on 2012 ESC HF guidelines. HF nurse up-titration: Up-titration of Mineralocorticoid Receptor Antagonist (MRA) in Heart Failure " De Novo" Left Ventricular Ejection Fraction ≤ 40% Patients, . Protocol based on 2012 ESC HF guidelines. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| betablocker mean relative dose | betablocker mean relative dose ( % to target dose) at baseline | n considered for baseline doses In both groups: patients, who were at the time of measuring the achieved doses after titration, the 4th month. We evaluated the 4 month titration process made by HF cardiologist vs HF nurse. Patients who left the study did not receive this intervention. | Mean | Standard Deviation | % to target dose |
|
| left ventricular ejection fraction % | Ejection fraction is a measurement of the percentage of blood leaving the heart each time it contracts. | Mean | Standard Deviation | %of blood leaving the heart /beat |
|
| Nt-proBNP | Nt-proBNP (N-terminal pro-B type natriuretic peptide) at discharge mean (SD) | other patients had BNP | Mean | Standard Deviation | pg/ml |
|
| 6 minute walking test | 6 minute walking test, meters. Six minute walking test. Measurement of exercise capacity . It provides information regarding functional capacity, response to therapy and prognosis across a range of chronic cardiopulmonary conditions. The six-minute walk test (6MWT) measures the distance (meters) an individual is able to walk over a total of six minutes on a hard, flat surface. | Mean | Standard Deviation | meters |
|
| Number of participants with New York Heart Association (NYHA) I,II,III,IV | Number of participants class I-IV New York Heart Association (NYHA) functional classification based on severity of symptoms and physical activity: NYHA I (better): No limitation of physical activity NYHA II: Slight limitation of ordinary physical activity, breathlessness NYHA III: marked limitation of physical activity. Comfortable at rest, but less than ordinary activity results in undue breathlessness, fatigue or palpitations NYHA IV ( worse): unable to carry on any physical activity without discomfort.Symptoms at rest can be present. If any physical activity, discomfort is increased. | Count of Participants | Participants | No |
|
| Minnesota living with heart failure questionnaire | Quality of Life measured by Minnesota Living With Heart Failure Questionnaire (MLWHFQ). The content of this questionnaire was selected to be representative of the ways heart failure and treatments can affect the key physical, emotional, social and mental dimensions of quality of life of patients with heart failure. It consist of 21-items with score 0-5. Final evaluation moves from 0 (none) to 105 (very much); a lower score means better quality of life. | Mean | Standard Deviation | units on a scale |
|
| European Quality of Life Scale: EuroQol- 5 Dimension index | European Quality of Life Scale: EuroQol- 5 Dimension index (Range: 1 full health-0 death). It measures health status self-reported by the patient. It has 5 domains: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension is divided into three levels: 1 no problem; 2 moderate problems; 3 extreme problems. This information is converted into a single summary index, by applying a formula that attaches specific country values to each of the levels in each dimension, that are subtracted from 1 (the full health). EQ-5D-3L-User-Guide_version-6.0 (1).pdf | Mean | Standard Deviation | score on a scale |
|
| ACEI mean relative dose | angiotensin-converting enzyme inhibitors mean relative dose ( % to target dose described in european heart failure guidelines) | n considered to calculate the mean baseline doses of ACEI in both groups: only the patients who received a prescription at baseline were included in the analysis. Every patient was prescribed betablocker but not ACEI. Alternatively It was possible to be prescribed ARB/sacubitril-valsartan or nothing | Mean | Standard Deviation | % to target dose |
|
| Angiotensin II Receptor Blockers (ARB) mean relative dose | ARB, angiotensin II receptor blockers, mean relative dose ( % to target dose).Target dose is described in European guidelines. Measured at baseline. | n considered to calculate the mean baseline doses of ARA in both groups: only the patients who received a prescription at baseline were included in the analysis. Every patient was prescribed betablocker but not ARB. Alternatively It was possible to be prescribed ACEI/sacubitril-valsartan or nothing | Mean | Standard Deviation | % to target dose |
|
| MRA mean relative dose | mineralocorticoid-receptor antagonists mean relative dose (% to target dose described in european heart failure guidelines) | n for MRA baseline doses in both groups: patients, who were at the time of measuring the achieved doses after titration, the 4th month and had a prescription during the titration period at any time. Every patient was prescribed betablocker but not MRA. It was possible not having the need of its prescription. | Mean | Standard Deviation | % to target dose |
|
| OG001 | HF Nurse Up-titration | Intervention: The cardiologist prescribes drugs and, driven by protocol, the HF nurse implements the up-titration. HF nurse up-titration: Up-titration of Beta-Blocker (BB) in Heart Failure " De Novo" Left Ventricular ejection Fraction (EF) ≤ 40% Patients. Protocol based on 2012 European Society of Cardiology (ESC) HF guidelines. HF nurse up-titration: Up-titration of Angiotensin Converting Enzyme Inhibitor (ACEI) in Heart Failure " De Novo" EF≤ 40% Patients. Protocol based on 2012 ESC HF guidelines. HF nurse up-titration: Up-titration of Angiotensin II Receptor Blocker (ARB) in Heart Failure " De Novo" EF≤ 40% Patients. Protocol based on 2012 ESC HF guidelines. HF nurse up-titration: Up-titration of Mineralocorticoid Receptor Antagonist (MRA) in Heart Failure " De Novo" EF≤ 40% Patients. Protocol based on 2012 ESC HF guidelines. |
|
|
|
| Secondary | Number of Participants With Worsening Renal Function (From Baseline to 4th Month) | Number of participants with worsening renal function during the titration process (from baseline to 4 month) that could be associated to the titration process (Creatinine increase >50% baseline creatinine or creatinine>3mg/dl, or Estimated Glomerular Filtration<25 ml/min/1.73 m2) | Posted | Count of Participants | Participants | 4 months |
|
|
|
|
| Secondary | Number of Participants With Potassium (K) ≥5.5 Meq/l (From Baseline to 4 Month) | Number of participants with Potassium≥ 5.5 meq/l during the titration process (from baseline to 4 month) that could be associated to this titration process | Posted | Count of Participants | Participants | 4 months |
|
|
|
|
| Secondary | Number of Participants With Symptomatic Hypotension (From Baseline to 4 Month) | Description: Number of participants with symptomatic hypotension during the titration process (from baseline to 4 month) that could be associated to this titration process. Symptomatic hypotension defined as symptoms such as dizziness or light headedness, associated to hypotension | Posted | Count of Participants | Participants | No | 4 months |
|
|
|
|
| Secondary | Number of Participants With Heart Rate (HR) < 50 Beats Per Minute (From Baseline to 4 Month) | Number of participants with Heart Rate (HR) < 50 beats per minute during the titration process (from baseline to 4 month) , which could be associated to the titration process. (with or without symptoms) | Posted | Count of Participants | Participants | 4 months |
|
|
|
|
| Secondary | Number of Patients With Atrio Ventricular (AV) Block Due to Titration | Number of patients with AV Block during the titration process, associated to the BB titration | Posted | Count of Participants | Participants | 4 months |
|
|
|
| Secondary | Number of Patients With Worsening of Heart Failure Signs and Symptoms | Number of patients with worsening of heart failure signs and symptoms during the titration process ( from baseline to 4 month) which could be associated to the titration process. | Posted | Count of Participants | Participants | 4 months |
|
|
|
|
| Secondary | Number of Patients With Admissions Due to Titration | Number of patients with admissions due to titration ( not due to other causes) | Posted | Count of Participants | Participants | 4 months |
|
|
|
| Secondary | Number of Patients: Mortality Due to Titration | Number of patients: Mortality due to titration ( not due to other causes) | Posted | Count of Participants | Participants | 4 months |
|
|
|
| Secondary | Number of Paticipants With Drug Stop (Some Titration Drug Withdrawal Due to Intolerance, no Need or Change to Other Treatment) | number of paticipants with drug Stop ( withdrawal) that occur during the titration process that could be due to an adverse event. ( it can be not only due to an adverse event but because there is no need of this drug or its substitution for another kind of drug) | Participants analyzed are only participants with drug withdrawal | Posted | Count of Participants | Participants | No | 4 months |
|
|
|
| Secondary | Change in % Left Ventricular Ejection Fraction | Change in % Left Ventricular Ejection Fraction (difference of change from baseline to 6 months between groups) Ejection fraction is a measurement of the percentage of blood leaving the heart each time it contracts. | It has to be taken into account that in outcome mesasures the order of groups and their number of participants is reversed ( first HF cardiologist, second HF nurse) in regard to those in the participant flow. ( first HF nurse, second HF cardiologist) | Posted | Mean | Standard Deviation | percentage of blood expelled/each beat | 6 months |
|
|
|
|
| Secondary | N-terminal Pro-B Type Natriuretic Peptide Improvement (Nt-proBNP) | Nt-proBNP (N-terminal pro-B type natriuretic peptide) Improvement (Decrease) difference of change from baseline to 6 months between groups, mean (SD) | BNP was analysed in 11 patients of both groups, instead of Nt proBNP ( 121/117). | Posted | Mean | Standard Deviation | pg/ml | 6 months |
|
|
|
|
| Secondary | 6 Minute Walking Test | 6 minute walking test improvement ( change) meters.Improvement (difference of change from baseline to 6 months between groups Six minute walking test. Measurement of exercise capacity is an integral element in assessment of patients with cardiopulmonary disease. It provides information regarding functional capacity, response to therapy and prognosis across a range of chronic cardiopulmonary conditions. The six-minute walk test (6MWT) measures the distance (meters) an individual is able to walk over a total of six minutes on a hard, flat surface. The goal is for the individual to walk as far as possible in six minutes. The individual is allowed to self-pace and rest as needed as they traverse back and forth along a marked walkway. | Posted | Mean | Standard Deviation | meters | 6 months |
|
|
|
|
| Secondary | Number of Participants n(%) in New York Heart Association Functional Classification I,II,III,IV | Number of participants class I-IV New York Heart Association (NYHA) functional classification, based on severity of symptoms and physical activity: NYHA I (better): No limitation of physical activity; NYHA II: Slight limitation of ordinary physical activity, breathlessness; NYHA III: marked limitation of physical activity. Comfortable at rest, but less than ordinary activity results in undue breathlessness, fatigue or palpitations; NYHA IV ( worse): unable to carry on any physical activity without discomfort.Symptoms at rest can be present. If any physical activity is undertaken discomfort is increased. | Posted | Count of Participants | Participants | 6 months |
|
|
|
| Secondary | Quality of Life: MLWHFQ | Quality of Life, measured by Minnesota Living with Heart Failure Questionnaire. Improvement (change) from baseline to 6 months. Minnesota Living With Heart Failure Questionnaire (MLWHFQ). The content of this questionnaire was selected to be representative of the ways heart failure and treatments can affect the key physical, emotional, social and mental dimensions of quality of life of patients with heart failure. It consist of 21-items with score 0-5. Final evaluation moves from 0 (none) to 105 (very much); a lower score means better quality of life. | Posted | Mean | Standard Deviation | score on a scale | 6 months |
|
|
|
|
| Secondary | European Quality of Life Scale: EuroQol- 5 Dimension Index | European Quality of Life Scale: EuroQol- 5 Dimension index (Range: 1 full health-0 death). It measures health status self-reported by the patient. It has 5 domains: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension is divided into three levels: 1 no problem; 2 some or moderate problems; 3 extreme problems. The EuroQol Research Foundation converts this information into a single summary index, by applying a formula that attaches specific country values (called weights) to each of the levels in each dimension. The index is calculated by subtracting the mentioned weights from 1, the value for full health. We measured the EuroQol-5D index improvement (change) from baseline to 6 months. More information in: EQ-5D-3L-User-Guide_version-6.0 (1).pdf | Posted | Mean | Standard Deviation | score on a scale | 6 months |
|
|
|
|
| Secondary | Number of Patients With Admissions Due to Heart Failure (HF) | Number of patients with hospital admissions due to Heart Failure. From Baseline to 6 months | Posted | Count of Participants | Participants | 6 months |
|
|
|
|
| Secondary | Number of Patients With Deaths | Number of Patients with deaths due to Cardiovascular and non cardiovascular causes | Posted | Count of Participants | Participants | 6 months |
|
|
|
|
| Secondary | ACEI % Relative Dose (Mean) With Regard to Target Dose | ACEI mean Relative dose is the mean dose of ACEI achieved 4 months after starting titration, relative to target dose (%) described in European guidelines | Posted | Mean | Standard Deviation | percentage of target dose | 4 Months |
|
|
|
|
| Secondary | ARB % Relative Dose (Mean) With Regard to Target Dose | ARB, angiotensin II receptor blockers, mean relative dose ( % to target dose). Target dose is described in European guidelines. Measured at 4 months after starting titration. | During the titration process several patients that at baseline did not have ARB prescription were prescribed this drug. | Posted | Mean | Standard Deviation | percentage of target dose | 4 months |
|
|
|
|
| Secondary | MRA % Relative Dose (Mean) With Regard to Target Dose | MRA % relative dose (mean) is the mean dose achieved 4 months after starting titration with regard to target dose (%) described in european guidelines | Posted | Mean | Standard Deviation | percentage of target dose | 4 months |
|
|
|
|
| 4 |
| 145 |
| 11 |
| 145 |
| 20 |
| 145 |
| EG001 | HF Nurse Up-titration | Intervention: The cardiologist prescribes drugs and, driven by protocol, the HF nurse implements the up-titration. HF nurse up-titration: Up-titration of Beta-Blocker (BB) in Heart Failure " De Novo" EF≤ 40% patients. Protocol based on 2012 European Society of Cardiology (ESC) HF guidelines. Cardiologist prescription and support HF nurse up-titration: Up-titration of Angiotensin Converting Enzyme Inhibitor (ACEI) in Heart Failure " De Novo" EF≤ 40% patients. Protocol based on 2012 ESC HF guidelines. Cardiologist prescription and support HF nurse up-titration: Up-titration of Angiotensin II Receptor Blocker (ARB) in Heart Failure " De Novo" EF≤ 40% patients. Protocol based on 2012 ESC HF guidelines. Cardiologist prescription and support HF nurse up-titration: Up-titration of Mineralocorticoid Receptor Antagonist (MRA) in Heart Failure " De Novo" EF≤ 40% patients. Protocol based on 2012 ESC HF guidelines. Cardiologist prescription and support | 3 | 144 | 2 | 144 | 22 | 144 |
|
|
| symptomatic hypotension | Cardiac disorders | Systematic Assessment | symptomatic hypotension possibly due to the titration process |
|
Not provided
Not provided
| juanaoy@hotmail.com |
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| NYHA III |
|
| NYHA IV |
|
| ARB stop |
|
| MRA stop |
|
| NYHA III |
|
| NYHA IV |
|