| CTRI Number |
CTRI/2025/02/081062 [Registered on: 21/02/2025] Trial Registered Prospectively |
| Last Modified On: |
30/09/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A Study to Determine the Efficacy and Safety of Finerenone on Morbidity and Mortality Among Hospitalized Heart Failure Patients |
|
Scientific Title of Study
|
Randomized Trial to Determine the Efficacy and Safety of Finerenone on Morbidity and Mortality Among Heart Failure Patients With Left Ventricular Ejection Fraction Greater Than or Equal to 40% Hospitalized Due to an Episode of Acute Decompensated Heart Failure (REDEFINE-HF) |
| Trial Acronym |
REDEFINE-HF |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 202301CPC Version 2.0 dated 3 Oct 2023 |
Protocol Number |
| NCT06008197 |
ClinicalTrials.gov |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vijay Kumar Chopra |
| Designation |
Senior Director |
| Affiliation |
Max Super Speciality Hospital |
| Address |
Department of Cardiology, Heart Failure and Clinical Research, Saket (East Block)- A Unit of Devki Devi foundation, 2, Press Enclave Road, Saket,
New Delhi
DELHI
110017
India |
| Phone |
9650896800 |
| Fax |
|
| Email |
vijay.chopra@maxhealthcare.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Kuldeep Patil |
| Designation |
Senior Director,Project Delivery |
| Affiliation |
Emerald Clinical Trials India Private Ltd |
| Address |
Emerald Clinical Trials India Private Ltd, Plot No 5, 12th Floor Prestige Khoday Towers, Raj Bhavan Road,
Bangalore
KARNATAKA
560001
India |
| Phone |
919975476427 |
| Fax |
918049421426 |
| Email |
Kpatil@emeraldclinical.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Kuldeep Patil |
| Designation |
Senior Director,Project Delivery |
| Affiliation |
Emerald Clinical Trials India Private Ltd |
| Address |
Emerald Clinical Trials India Private Ltd, Plot No 5, 12th Floor Prestige Khoday Towers, Raj Bhavan Road,
Bangalore
KARNATAKA
560001
India |
| Phone |
919975476427 |
| Fax |
918049421426 |
| Email |
Kpatil@emeraldclinical.com |
|
Source of Monetary or Material Support
Modification(s)
|
| CPC Clinical Research
2115N Scranton Street Suite 2040, Aurora, CO, USA 80045-7120 |
| Emerald Clinical Trials India Private Ltd, Plot
No. 5, Prestige Khoday Towers, 12th Floor Raj Bhavan Road Bengaluru (India) –
560001 |
|
|
Primary Sponsor
|
| Name |
CPC Clinical Research |
| Address |
2115 N Scranton Street #2040, Aurora, CO, USA 80045-7120 |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
Argentina
Australia
Brazil
Canada
Colombia
Croatia
Czech Republic
Germany
Greece
Hungary
India
Italy
Lithuania
Malaysia
Mexico
Peru
Poland
South Africa
Spain
Sri Lanka
Taiwan
United Kingdom
United States of America |
Sites of Study
Modification(s)
|
| No of Sites = 11 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Abraham Oomman |
Apollo Hospitals |
Department of Interventional Cardiologist, No.21, Greams Lane, Off Greams Road, Chennai 600 006, Tamil Nadu, India.
Chennai
TAMIL NADU |
9841174578
drabrahamoomman@gmail.com |
| Dr Rajat Sharma |
Fortis Hospital |
Cardiac Electrophysiology - Heart Rhythm & Pacing Division, Phase-VIII, Sector-62, Mohali 160062,
Fatehgarh Sahib
PUNJAB |
8283812952
rajat.sharma@fortishealthcare.com |
| Dr Ravi Vishnu Prasad |
Indira Gandhi Institute of Medical Sciences (IGIMS) |
Department of Cardiology, Dumra Road, Near A G Colony Park, Sheikhpura, Patna, Bihar 800014
Patna
BIHAR |
919431646727
rvpd2004@yahoo.co.in |
| Dr Jabir Abdullakutty |
Lisie Hospital |
Department of Cardiovascular Clinical Research, P.B.No.:3053, Kochi-682018, Kerala
Ernakulam
KERALA |
919447011773
drjabi@yahoo.co.in |
| Dr Kamal H Sharma |
Matis Multispeciality Hospital |
Department of Interventional Cardiologist, Adanai CNG Gas Station Opp, Motera Cross Road, Near Motera Bus Stop, Motera, Ahmedabad, Gujarat-380005
Ahmadabad
GUJARAT |
919426020154
kamalcardiodoc@gmail.com |
| Dr Vijay Kumar Chopra |
Max Super Speciality Hospital, Saket (East Block) |
Department of Clinical Cardiology, Heart Failure and Research, A Unit of Devki Devi foundation, 2, Press Enclave Road, Saket, New-Delhi-110017
New Delhi
DELHI |
9650896800
vijay.chopra@maxhealthcare.com |
| Dr Praveen Chandra |
Medanta- The Medicity Hospital |
Department of Interventional and Structural Heart Cardiology, Sector-38, Gurugram, Haryana-122001
Gurgaon
HARYANA |
9810125370
praveen.chandra@medanta.org |
| Dr Shantanu Pradeep Sengupta |
Sengupta Hospital & Research Institute |
Department of Echo Cardiologist, Ravinagar Square, Nagpur 440033, India
Nagpur
MAHARASHTRA |
9923190925
senguptasp@gmail.com |
| Dr Jitendra Pal Singh Sawhney |
Sir Ganga Ram Hospital, SGRH Marg |
Department of Cardiology, Rajinder Nagar, New Delhi INDIA -110060
New Delhi
DELHI |
9810059773
jpssawhney@yahoo.com |
| Dr Ramya Das NK |
Sree Chitra Tirunal Institute for Medical Sciences and Technology |
Department of Cardiology, Medical College PO, Thiruvanathapuram-695011, Kerala.
Thiruvananthapuram
KERALA |
8281641327
ramyadasnk@gmail.com |
| Dr Sandeep Bansal |
VMMC & Safdarjung Hospital |
Department of Cardiology, New Delhi- 110029
New Delhi
DELHI |
9810543368
drsbansal2000@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 11 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Submittted/Under Review |
| Institutional Ethics Committee |
Approved |
| Institutional Ethics Committee |
Approved |
| Institutional Ethics Committee |
Approved |
| Institutional Ethics Committee |
Approved |
| Institutional Ethics Committee |
Approved |
| Institutional Ethics Committee VMMC and Safdarjung Hospital |
Submittted/Under Review |
| Institutional Ethics Committee SCTIMST |
Submittted/Under Review |
| Institutional Ethics Committee, IGIMS |
Approved |
| Shakti Hospital Ethics Committee |
Approved |
| Sir Ganga Ram Hospital Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I50||Heart failure, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Finerenone |
Finerenone dosing is based on the regimen used in the ongoing FINEARTS-HF trial.
For participants with an eGFR less than or equal to 60ml/min/1.73 m2: Starting dose is 10 mg once daily and maximum dose 20 mg once daily for minimum of 6 months time.
For participants with an eGFR more than 60ml/min/1.73 m2: Starting dose is 20 mg once daily and maximum dose 40 mg once daily for minimum of 6 months time.
Finerenone is administered orally as immediate release tablets. |
| Comparator Agent |
Placebo |
Matching oral placebo |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Provide electronic or written informed consent, either personally or through a legally authorized representative.
2. Age ≥ 18 years.
3. Current hospitalization or recently discharged with the primary diagnosis of heart failure.
4. Heart failure signs and symptoms at the time of hospital admission.
5. Imaging evidence of mildly reduced or preserved left ventricular ejection fraction (EF) (40% or higher).
6. 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.
7. Fulfillment of the following stabilization criteria (if randomized during hospitalization): a. Systolic blood pressure (BP) ≥ 100 mmHg and no symptoms of hypotension in the 6 hours prior to randomization; b. No increase in intravenous diuretic dose for 6 hours prior to randomization; c. No intravenous vasodilators, including nitrates, within the last 6 hours prior to randomization; d. No intravenous inotropic drugs or mechanical circulatory support for 24 hours prior to randomization.
8. Treatment during the index hospitalization with at least 1 intravenous dose of a loop diuretic, e.g. furosemide, torsemide, bumetanide.
9. Women of childbearing potential1 can only be included in the study if a pregnancy test is negative at screening and if they agree to use adequate contraception which is consistent with local regulations regarding the methods for contraception for the duration of the study. |
|
| ExclusionCriteria |
| Details |
1. Treatment with a mineralocorticoid receptor antagonist (MRA).
2. Documented prior history of sever hyperkalemia in the setting of MRA use.
3. Estimated glomerular filtration rate (eGFR) less than 25mL/min/1.73m2 or serum/plasma potassium more than 5.0mmol/L at screening.
4. Acute myocardial infarction, coronary revascularization, valve replacement/repair, or implantation of a cardiac resynchronization therapy device within 30 days.
5. Prior heart transplant or listed for heart transplant with expectation to receive a transplant during the course of this trial, or planned for palliative care for HF, or currently using or plan for mechanical circulatory support, e.g., left ventricular assist device, intra-aortic balloon pump, or patients on mechanical ventilation or patients with planned outpatient inotropic support.
6. Hemodynamically significant (severe) uncorrected primary cardiac valvular disease.
7. 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.
8. Probable alternative cause of participants heart failure symptoms.
9. Concomitant systemic therapy with potent cytochrome P450 isoenzyme 3A4 (CYP3A4) inhibitors or moderate CYP3A4 inducers, or potent CYP3A4 inducers.
10. Concomitant treatment with renin inhibitor, more than one angiotensin converting enzyme inhibitor (ACEi), angiotensin receptor blocker (ARB) or ARNI, or with a potassium-sparing diuretic.
11. Any other condition or therapy (e.g., cardiogenic shock, clinically overt severe hepatic insufficiency, Addison’s disease, or other severe condition.
12. Participation in another interventional clinical study or treatment with another investigational medicine or device within 30 days prior to randomization. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Composite total of HF events and cardiovascular (CV) death. Total (first and subsequent) HF hospitalizations, urgent visits for worsening HF, and CV deaths with finerenone compared to placebo.
2. Number of serious adverse events. Occurrence of serious adverse events (excluding efficacy endpoints) with finerenone compared to placebo.
3. Number of adverse events leading to discontinuation of study drug. Occurrence of serious adverse events leading to study drug discontinuation with finerenone compared to placebo. |
Ongoing, up to 30 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Time to first occurrence of the composite of CV death or HF event. |
Ongoing, up to 30 months |
| Total HF events. |
Ongoing, up to 30 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 with finerenone compared to placebo. |
Ongoing, up to 30 months |
| Time to death from any cause with finerenone compared to placebo. |
Ongoing, up to 30 months |
|
|
Target Sample Size
|
Total Sample Size="5200"
Sample Size from India="108"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
03/03/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
13/01/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is a Phase 3 randomized, double blind trial where Finerenone will be compared with placebo to determine the efficacy and safety of treatment in patients hospitalized with acute decompensated heart failure (HF) and mildly reduced or preserved left ventricular ejection fraction. Since patients hospitalized for acute decompensated HF, including those with HFp/mrEF, are at high risk of subsequent adverse events (AEs), including hospital readmissions and urgent visits due to HF, as well as CV death,currently there is a substantial and unmet need for additional efficacious and safe treatment options. Establishing that finerenone can provide an early reduction in the risk of HF events and CV death among patients with acute HFp/mrEF would significantly change clinical practice.
Patients will be screened based on the inclusion/exclusion criteria and will be randomly allocated(1:1) to receive one finerenone or matching placebo tablet orally each day.The dose will be adjusted based on the patient’s kidney function and serum/plasma potassium.
The outcome will be assessed based on the primary objective: whether Finerenone reduces total HF events and CV death compared with placebo in patients hospitalized with acute decompensated HFmrEF/HFpEF, secondary objective: by determining the effects of finerenone compared with placebo on clinical events and change in Kansas City Cardiomyopathy Questionnaire Total Symptom Score (KCCQ-TSS) and the safety objective: by assessing the occurrence of AEs with finerenone compared with placebo.
The analysis of the endpoints will be performed as per the Statistical Analysis Plan.
DCGI approval was obtained for the study on 3-Jan-2025. |