Date

2026-01-06

Protocol

Protocol changed

Item Changed

Intervention(s) planned

Previous Version

Study sites- National Hospital of Sri Lanka, Colombo North Teaching Hospital, Kandy National Hospital, Colombo South Teaching Hospital, Jaffna Teaching Hospital, Negombo District General Hospital. Randomization- Participants will be randomly assigned to treatment groups (Investigational medicinal product-IMP/placebo) based on a computer-generated randomization schedule prepared before the study by, or under the supervision of, the sponsor statistician or delegate. Randomization will be balanced by using randomly permuted blocks for each site and stratified by country. Comparator– Matching placebo containing lactose Intervention - Patients will be randomly allocated (1:1) to receive either one finerenone tablet (dosed at 10 mg, 20 mg, 40 mg depending on kidney function) or one placebo tablet orally each day. In both groups, background heart failure therapy will be maintained as per local guidelines, to reflect real-world practice. The study dose will be adjusted based on the patient’s kidney function and serum/plasma potassium. The starting dose of finerenone or placebo will depend on the local laboratory eGFR value at baseline. The investigator will titrate the dose of study intervention once the participant has been on a stable dose for 30±7 days. Participants who do not tolerate their starting dose may be down-titrated or interrupted at any point during the study, including between scheduled visits if required for safety reasons. Up titration of dose may be performed from Day 30 onward at any scheduled or unscheduled contact. eGFR and serum/plasma potassium will be checked 28±7 days after dose adjustment and at any other time deemed appropriate by the investigator. Patients will be instructed to take one tablet of study medication by mouth at approximately the same time each day, with a glass of water with or without food. Tablets containing 10 mg and 20 mg finerenone will differ in size from 40 mg finerenone tablets, but will be identical in appearance (size, shape, color) to matching placebo tablets. The packaging and labelling will be designed to maintain the blinding of the investigator’s team and the participants. The placebo tablet is active-free tablet and contains lactose. Intervention Arm: Drug: Finerenone Dose:10 mg, 20 mg, or 40 mg once daily (starting dose depends on baseline eGFR: 10 mg for eGFR 25–60 mL/min/1.73 m²; 20 mg for eGFR >60 mL/min/1.73 m²). Dose adjustments are made based on potassium levels and kidney function. Route: Oral Duration: Approximately 30 months (mean participant duration). Frequency: Once daily. Control Arm Drug: Matching placebo. Dose Identical in appearance to finerenone tablets (10 mg, 20 mg, or 40 mg). Route: Oral. Duration: Same as intervention arm (~30 months). Frequency: Once daily. Standard Therapy (Background Treatment) All participants (both intervention and control arms) receive standard care for heart failure with reduced ejection fraction (HFrEF), which may include: Beta-blockers. Renin-angiotensin system antagonists (e.g., ACE inhibitors, ARBs, or ARNIs). Sodium-glucose co-transporter 2 (SGLT2) inhibitors. Diuretics. Other guideline-directed therapies, as per local practice. Blinding This is a double-blind study. The following groups are blinded: 1. Participants – Unaware of whether they receive finerenone or placebo. 2. Healthcare providers – Investigators and site staff are blinded to treatment assignment. 3. Data collectors – Personnel collecting efficacy/safety data are blinded. 4. Outcome adjudicators – Clinical Endpoint Committee members reviewing events are blinded. 5. Data analysts – Statisticians analyzing results remain blinded until final analysis. Unblinding will be permitted only in medical emergencies where knowledge of treatment is critical for clinical management. Sponsor safety staff may unblind for expedited reporting of serious adverse events. Participants will be randomly assigned to treatment groups based on a computer-generated randomization schedule prepared before the study by or under the supervision of the sponsor statistician or delegate. Randomization will be balanced by using randomly permuted blocks for each site and stratified by country.

Next Version

Study sites- National Hospital of Sri Lanka, Colombo North Teaching Hospital, Kandy National Hospital, Colombo South Teaching Hospital, Jaffna Teaching Hospital, Negombo District General Hospital, Teaching Hospital Kurunegala