Heart Failure
Conditions
Brief summary
Relapse of cardiomyopathy at any time during the study after drug withdrawal, defined by at least one of the following: 1. A reduction in LVEF of more than 10% (as long as the overall LVEF is < 50%). 2. A reduction in LVEF of more than 10% accompanied by a >15% increase in left ventricular end-systolic volume. 3. Unplanned hospital admission or visit to the Emergency Department/day hospital due to decompensated HF requiring the administration of intravenous diuretics.
Detailed description
Combined total mortality, cardiovascular mortality, hospital admission or visit to the Emergency Department/unplanned day hospital for HF, and sustained atrial or ventricular arrhythmias (>30 seconds)., Changes with respect to the basal levels of BP and HR., Change from baseline in LVEF, LVTVV, left atrial volume indexed by body surface area (VAIi), and changes from baseline in left ventricular (LV) longitudinal global strain (LSG)., Quantitative changes in NT-proBNP numbers., Changes in the quality of life questionnaires according to The Kansas City Cardiomyopathy Questionnaire (KCCQ) and Minnesota Living With Heart Failure (MLHFQ) scale.
Interventions
DRUGeplerenona cinfa 50 mg comprimidos recubiertos con película EFG
DRUGeplerenona cinfa 25 mg comprimidos recubiertos con película EFG
DRUGDiován Cardio 40 mg comprimidos recubiertos con película
DRUGDiován 320 mg comprimidos recubiertos con película
DRUGBisoprolol Cor Aristo 10 mg comprimidos recubiertos con película EFG
DRUGBisoprolol Cor Aristo 5 mg comprimidos recubiertos con película EFG
DRUGFurosemida KERN PHARMA 40 mg comprimidos EFG
DRUGBisoprolol Cor Aristo 2
DRUGDiován 80 mg comprimidos recubiertos con película
DRUGDiován 160 mg comprimidos recubiertos con película
Sponsors
Fundacion Para La Formacion E Investigacion Sanitaria De La Region De Murcia
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Relapse of cardiomyopathy at any time during the study after drug withdrawal, defined by at least one of the following: 1. A reduction in LVEF of more than 10% (as long as the overall LVEF is < 50%). 2. A reduction in LVEF of more than 10% accompanied by a >15% increase in left ventricular end-systolic volume. 3. Unplanned hospital admission or visit to the Emergency Department/day hospital due to decompensated HF requiring the administration of intravenous diuretics. | — |
Secondary
| Measure | Time frame |
|---|---|
| Combined total mortality, cardiovascular mortality, hospital admission or visit to the Emergency Department/unplanned day hospital for HF, and sustained atrial or ventricular arrhythmias (>30 seconds)., Changes with respect to the basal levels of BP and HR., Change from baseline in LVEF, LVTVV, left atrial volume indexed by body surface area (VAIi), and changes from baseline in left ventricular (LV) longitudinal global strain (LSG)., Quantitative changes in NT-proBNP numbers., Changes in the quality of life questionnaires according to The Kansas City Cardiomyopathy Questionnaire (KCCQ) and Minnesota Living With Heart Failure (MLHFQ) scale. | — |
Countries
Spain
Outcome results
None listed