Heart Failure
Conditions
Interventions
Study sites:
The National Hospital of Sri Lanka, Colombo North Teaching Hospital, Sri Jayewardenepura General Hospital, Kandy National Hospital, District General Hospital Polonnaruwa, Colombo South T
Sponsors
CPC Clinical Research
Eligibility
Inclusion criteria
Inclusion criteria: • Males and females age >=18 years • Current hospitalization or recently discharged with the primary diagnosis of heart failure • Heart failure signs and symptoms at the time of hospital admission • Imaging evidence of mildly reduced or preserved left ventricular ejection fraction (EF) (40% or higher) • Elevated N-terminal pro B-type natriuretic peptide (NTproBNP) >=1000 pg/mL or B-type natriuretic peptide (BNP) >=250 pg/mL for patients without atrial fibrillation (AF); or elevated NTproBNP >=2000 pg/mL or BNP >=500 pg/mL for patients with AF
Exclusion criteria
Exclusion criteria: • Treatment with a mineralocorticoid receptor antagonist (MRA) • Documented prior history of severe hyperkalemia in the setting of MRA use • Estimated glomerular filtration rate (eGFR) 5.0 mmol/L at screening • Acute myocardial infarction, coronary revascularization, valve replacement/repair, or implantation of a cardiac resynchronization therapy device within 30 days • Hemodynamically significant (severe) uncorrected primary cardiac valvular disease • Cardiomyopathy due to known acute inflammatory heart, infiltrative diseases, accumulation diseases, muscular dystrophies, cardiomyopathy with reversible causes, known hypertrophic obstructive cardiomyopathy, complex congenital heart disease, or known pericardial constriction • Probable alternative cause of participant's heart failure symptoms • Concomitant systemic therapy with potent cytochrome P450 isoenzyme 3A4 (CYP3A4) inhibitors or moderate CYP3A4 inducers, or potent CYP3A4 inducers
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Composite total of HF events and CV death. (Total (first and subsequent) HF hospitalizations, urgent visits for worsening HF, and CV deaths with finerenone compared to placebo). [Ongoing, up to 30 months] Number of serious adverse events. The expected adverse drug events are hyperkalemia, hypotension, impairment of kidney function, hyperuricemia, and hyponatremia [ Ongoing, up to 30 months] Number of adverse events leading to discontinuation of study drug. The expected adverse drug events are hyperkalemia, hypotension, impairment of kidney function, hyperuricemia, and hyponatremia [ Ongoing, up to 30 months] | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to first occurrence of the composite of CV death or HF event [Ongoing, up to30 months] Change from baseline in the Total Symptom Score on the Kansas City Cardiomyopathy Questionnaire (KCCQ-TSS) at Month 6 [ 6 months] Time to CV death [ Ongoing, up to 30 months] Total HF events [ Ongoing, up to 30 months] Time to death from any cause [ Ongoing, up to 30 months] Total hospitalizations for any cause [ Ongoing, up to 30 months] Total number of days alive and out of the hospital [ Ongoing, up to 30 months] Number of patients with sustained decrease in eGFR =40% relative to baseline [ Ongoing, up to 30 months] Number of patients with sustained eGFR <15 ml/min/1.73 m^2 [ Ongoing, up to 30 months] Number of patients requiring initiation of dialysis or renal transplant. [ Ongoing, up to 30 months] | — |
Countries
Argentina,Australia,Brazil,Canada,Croatia,Czech Republic,Germany,Greece,Hungary,India,Italy,Korea, Democratic People's Republic of,Lithuania,Malaysia,Peru,Poland,Spain,Sri Lanka,Taiwan, Province of Ch
Contacts
Public ContactDr. Gamini Galappatthy
Consultant Cardiologist
Outcome results
None listed