Date

2026-01-27

Protocol

Protocol changed

Item Changed

Intervention(s) planned

Previous Version

1. The study setting/ Study sites: • The National Hospital of Sri Lanka • Colombo North Teaching Hospital • Kandy National Hospital • Colombo South Teaching Hospital • Jaffna Teaching Hospital • Negombo District General Hospital 2. This is an open-label study. Participants will be randomly assigned (1:1) to treatment groups (e.g., IP or standard of care) 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 and LVEF (<40%, > 40%). 3. Intervention: Participants will be randomly allocated (1:1) to standard of care management or an early, intensive management strategy including finerenone and empagliflozin. The dose will be adjusted based on the patient’s kidney function and serum/plasma potassium. Participants allocated to the early, intensive management strategy will receive empagliflozin 10 mg daily and finerenone once daily at a starting dose of 10 or 20 mg based on the local laboratory eGFR at baseline. The investigator will titrate the finerenone dose once the participant has been on a stable dose for 28±7 days. Participants who do not tolerate their starting dose of 20 mg may be down titrated at any point during the study, including between scheduled visits if required for safety reasons. Up titration of dose may be performed from Day 28 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. Participants will be instructed to take one tablet of finerenone at approximately the same time each day, with a glass of water with or without food, and to take empagliflozin as specified on the label. Tablets containing 10 mg and 20 mg finerenone will differ in size from 40 mg finerenone tablets. Participants in the standard of care arm will be managed by their usual care providers who will receive a summary of HF (Heart Failure) guideline recommendations. Eligibility criteria were selected to define a study population at high risk for worsening HF events while excluding those who may be exposed to particular risks with the intervention. Standard therapy given in place of placebo is dependent on the patients usual care. Since the study is open label, no groups are blinded to the intervention.

Next Version

1. The study setting/ Study sites: • The 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 2. This is an open-label study. Participants will be randomly assigned (1:1) to treatment groups (e.g., IP or standard of care) 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 and LVEF (<40%, > 40%). 3. Intervention: Participants will be randomly allocated (1:1) to standard of care management or an early, intensive management strategy including finerenone and empagliflozin. The dose will be adjusted based on the patient’s kidney function and serum/plasma potassium. Participants allocated to the early, intensive management strategy will receive empagliflozin 10 mg daily and finerenone once daily at a starting dose of 10 or 20 mg based on the local laboratory eGFR at baseline. The investigator will titrate the finerenone dose once the participant has been on a stable dose for 28±7 days. Participants who do not tolerate their starting dose of 20 mg may be down titrated at any point during the study, including between scheduled visits if required for safety reasons. Up titration of dose may be performed from Day 28 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. Participants will be instructed to take one tablet of finerenone at approximately the same time each day, with a glass of water with or without food, and to take empagliflozin as specified on the label. Tablets containing 10 mg and 20 mg finerenone will differ in size from 40 mg finerenone tablets. Participants in the standard of care arm will be managed by their usual care providers who will receive a summary of HF (Heart Failure) guideline recommendations. Eligibility criteria were selected to define a study population at high risk for worsening HF events while excluding those who may be exposed to particular risks with the intervention. Standard therapy given in place of placebo is dependent on the patients usual care. Since the study is open label, no groups are blinded to the intervention.