Health Condition 1: I509- Heart failure, unspecified
Conditions
Interventions
Intervention1: Finerenone BAY94-8862): 10/20 mg OD for 3 years and 4 months.
Control Intervention1: Placebo: 10/20 mg OD for 3 years and 4 months
Sponsors
Bayer Pharmaceuticals Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1 Participant (male or female) must be aged 40 years and older. 2 Diagnosis of heart failure with New York Heart Association(NYHA) class II–IV, ambulatory or hospitalized primarily for heart failure. 3 On diuretic treatment for at least 30 days prior to randomization. 4 Documented left ventricular ejection fraction (LVEF) of =40% measured by any modality within the last 12 months. 5 Structural heart abnormalities based on any local imaging measurement within the last 12 months, defined by at least one of the following findings: left atrial diameter (LAD) more than or equal to 3.8cm left atrial area (LAA) more than or equal to 20cm2 left atrial volume index (LAVI) more than 30 mL/m2 left ventricular mass index (LVMI) more than or equal to 115 g/m2 (male)/ 95 g/m2 (Female) septal thickness or posterior wall thickness more than or equal to 1.1 cm 6 n-terminal prohormone B-type natriuretic peptide (NT-proBNP) more than or equal to 300 pg/mL B-type natriuretic peptide (BNP more than or equal to 100 pg/mL) in SR or NT-proBNP more than or equal to 900pg/mL (BNP more than or equal to 300 pg/mL) in atrial fibrillation (AF) obtained at the following time: Within 90 days prior to randomization if patient had been hospitalized for heart failure (HF) requiring initiation or change in HF therapy or if patient had an urgent visit for HF requiring intravenous (IV) diuretic therapy, both within 90 days prior to randomization or Within 30 days prior to randomization if patient has not been hospitalized for HF nor had an urgent HF visit within the past 90 days. 7 Women of childbearing potential can only be included in the study if a pregnancy test is negative at screening and baseline and if they agree to use adequate contraception which is consistent with local regulations regarding the methods for contraception for those participating in clinical trials.
Exclusion criteria
Exclusion criteria: 1 Estimated glomerular filtration rate (eGFR) less than 25 mL/min/1.73 m² at either screening or randomization visit 2 Serum/plasma potassium more than 5.0 mmol/L at either screening or randomization visit 3 Acute inflammatory heart disease, e.g. acute myocarditis, within 90 days prior to randomization 4 Myocardial infarction or any event which could have reduced the ejection fraction within 90 days prior to randomization 5 Coronary artery bypass graft surgery in the 90 days prior to randomization 6 Percutaneous coronary intervention in the 30 days prior to randomization 7 Stroke or transient ischemic cerebral attack within 90 days prior to randomization 8 Probable alternative cause of participants’ HF symptoms that in the opinion of the investigator primarily accounts for patient’s dyspnea such as significant pulmonary disease, anemia or obesity. Specifically, patients with the below are excluded: Severe pulmonary disease requiring home oxygen, or chronic oral steroid therapy, History of primary pulmonary arterial hypertension, Hemoglobin less than 10 g/dl, Valvular heart disease considered by the investigator to be clinically significant, Body Mass Index (BMI) more than 50 kg/m2 at screening 9 Systolic blood pressure(SBP) more than or equal to 160 mmHg if not on treatment with =3 blood pressure lowering medications or more than or equal to 180 mmHg irrespective of treatments, on 2 consecutive measurements at least 2-minute apart, at screening or at randomization.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Composite CV endpoints: CV death Hospitalization due to HF (Heart Failure) Urgent HF visitsTimepoint: 3.5 years | — |
Secondary
| Measure | Time frame |
|---|---|
| All-cause mortalityTimepoint: 3.5 years;Sustained decrease in estimated glomerular filtration rate more than or equal to 40 percent relative to baseline over at least 4 weeks. or Sustained eGFR decline less than 15 ml per min or Initiation of dialysis or renal transplantation.Timepoint: 3.5 years;Total Symptom Score (TSS)Timepoint: 6 Months, 9 months and 12 Months from baseline. | — |
Countries
Argentina, Australia, Austria, Brazil, Bulgaria, Canada, China, Czech Republic, Denmark, Finland, Greece, Hungary, India, Israel, Italy, Latvia, Lithuania, Malaysia, Netherlands, New Zealand, Portugal, Russian Federation, Slovakia, Spain, Taiwan, United Kingdom, United States of America
Contacts
Public ContactAshish Gawde
Bayer Pharmaceuticals Private Limited
Outcome results
None listed