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CTRI Number  CTRI/2021/03/032071 [Registered on: 17/03/2021] Trial Registered Prospectively
Last Modified On: 07/04/2025
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 clinical study to assess safety and efficacy of finerenone in patients of Heart Failure and with preserved ejection fraction.  
Scientific Title of Study
Modification(s)  		 A multicenter, randomized, double-blind, parallel-group, placebo-controlled study to evaluate the efficacy and safety of finerenone on morbidity and mortality in participants with heart failure (NYHA II-IV) and left ventricular ejection fraction more than or equal to 40% (LVEF more than or equal to 40%) 
Trial Acronym  FINEARTS-HF 
Secondary IDs if Any  
Secondary ID  Identifier 
20103 Amendment 1 Version 2.0 dated 21-Sep-2020  Protocol Number 
2020-000306-29  EudraCT 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Ashish Gawde 
Designation  Country Medical Director 
Affiliation  Bayer Pharmaceuticals Private Limited 
Address  Bayer Pharmaceuticals Private Limited Pharmaceuticals Division Research and Development Pharmaceuticals Bayer House Central Avenue

Thane
MAHARASHTRA
400607
India 
Phone    
Fax    
Email  ashish.gawde@bayer.com  
 
Details of Contact Person
Scientific Query  
Name  Ashish Gawde 
Designation  Country Medical Director 
Affiliation  Bayer Pharmaceuticals Private Limited 
Address  Bayer Pharmaceuticals Private Limited Pharmaceuticals Division Research and Development Pharmaceuticals Bayer House Central Avenue

Thane
MAHARASHTRA
400607
India 
Phone    
Fax    
Email  ashish.gawde@bayer.com  
 
Details of Contact Person
Public Query  
Name  Ashish Gawde 
Designation  Country Medical Director 
Affiliation  Bayer Pharmaceuticals Private Limited 
Address  Bayer Pharmaceuticals Private Limited Pharmaceuticals Division Research and Development Pharmaceuticals Bayer House Central Avenue

Thane
MAHARASHTRA
400607
India 
Phone    
Fax    
Email  ashish.gawde@bayer.com  
 
Source of Monetary or Material Support  
Bayer AG 51368 Leverkusen Germany 
 
Primary Sponsor  
Name  Bayer Pharmaceuticals Private Limited 
Address  Bayer Pharmaceuticals Private Limited Pharmaceuticals Division Research and Development Pharmaceuticals Bayer House Central Avenue 400607 Thane Maharashtra India  
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     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  
Sites of Study
Modification(s)  
No of Sites = 7  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Shireesh Sathe  Deenanath Mangeshkar Hospital and Research Center  Deenanath Mangeshkar Hospital and Research Center, Department of Cardiology, 3rd Floor OPD Super Specialty Building, Near Mhatre Bridge Erandwane Pune 411004
Pune
MAHARASHTRA 		 9822053216

shireesh.sathe@gmail.com 
Dr Arunangshu Ganguly  Healthworld Hospitals  Department of Cardiology, C-49, Commercial Area, Opp. ESIC Sub-Regional Office, City Centre, Durgapur - 713216
Barddhaman
WEST BENGAL 		 913432547755

arunangshu@hwhos.com 
Dr Milind Gadkari  KEM Hospital  KEM Hospital, 5th Floor, Department of Cardiology Diamond Jubilee Building Sardar Moodliar Road Rasta Peth Pune 411011
Pune
MAHARASHTRA 		 9822030120

gadkaris@gmail.com 
Dr Ajaykumar Mahajan  Lokmanya Tilak Municipal Medical College and Lokmanya Tilak Municipal General Hospital  Lokmanya Tilak Municipal Medical College and Lokmanya Tilak Municipal General Hospital Dr. Ajaykumar Mahajan, Professor, Department of Cardiology, Medical College Building, 2nd Floor, Room No 17, Sion, Mumbai – 400022
Mumbai
MAHARASHTRA 		 919920432639

draumahajan@gmail.com 
Dr Vijay Kumar Chopra  Max Super Specialty Hospital   Max Super Specialty Hospital, (A Unit of Devki Foundation) Department of Cardiology, East Block No 1,2 Press Enclave Road Saket, South Delhi New Delhi - 110017
South
DELHI 		 9650896800

Vijay.Chopra@maxhealthcare.com 
Dr Ajit Mullasari  The Madras Medical Mission  The Madras Medical Mission, Department of Cardiology, No. 4-A, Dr. J.J. Nagar, Mogappair, Chennai – 600037. Tamil Nadu, India
Chennai
TAMIL NADU 		 91-4426565961

icvddoctors@mmm.org.in 
Dr Sandeep Bansal  Vardhman Mahavir Medical College and Safdarjung Hospital  NH 48 Near AIIMS Hospital Ansari Nagar West New Delhi 110029
New Delhi
DELHI 		 911126133368

drsbansal2000@yahoo.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 7  
Name of Committee  Approval Status 
IEC Human Research LTMMC and General Hospital  Approved 
IEC The Madras Medical Mission  Approved 
Institutional Ethics Committee  Approved 
Institutional Ethics Committee  Approved 
Institutional Ethics Committee - Clinical Trials  Approved 
KEM Hospital Research Centre Ethics Committee  Approved 
VMMC and Safdarjung Hospital Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I509||Heart failure, unspecified,  
 
Intervention / Comparator Agent
Modification(s)  
Type  Name  Details 
Intervention  Finerenone BAY94-8862)  10/20 mg OD for 3 years and 4 months. 
Comparator Agent  Placebo  10/20 mg OD for 3 years and 4 months 
 
Inclusion Criteria
Modification(s)  
Age From  40.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  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.
 
 
ExclusionCriteria 
Details  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. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Double Blind Double Dummy 
Primary Outcome  
Outcome  TimePoints 
Composite CV endpoints:
CV death
Hospitalization due to HF (Heart Failure)
Urgent HF visits 		 3.5 years 
 
Secondary Outcome  
Outcome  TimePoints 
Total Symptom Score (TSS)  6 Months, 9 months and 12 Months from baseline.  
All-cause mortality  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.  		 3.5 years 
 
Target Sample Size   Total Sample Size="5500"
Sample Size from India="50" 
Final Enrollment numbers achieved (Total)= "6016"
Final Enrollment numbers achieved (India)="28" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   19/03/2021 
Date of Study Completion (India) 01/06/2024 
Date of First Enrollment (Global)  14/09/2020 
Date of Study Completion (Global) 14/06/2024 
Estimated Duration of Trial   Years="3"
Months="5"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary
Modification(s)  		 The purpose of this study is to evaluate the effect of finerenone compared to placebo (a tablet without active substance) in the reduction of cardiovascular death (generally meaning death due to disease of the heart or blood vessels) and total Heart Failure (HF) events, including HF hospitalization and urgent visits for HF(generally meaning a hospital stay or urgent presentation to a healthcare unit due to worsening symptoms of heart failure) in patients suffering from HF with an ejection fraction greater than or equal to 40%. Researchers will also collect information on how much the heart disease has impact on patient’s lives, change of kidney function, and how well finerenone treatment is tolerated. The study plans to enroll 5500 male and female patients of the age of 40 years and above suffering from heart failure with ejection fraction greater than or equal to 40%. Participants will take the study product as oral tablet with a dose between 0 (Placebo) 40 mg once daily. Study duration will be up to 43 months. 
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