CTRI

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CTRI Number

CTRI/2025/12/099785 [Registered on: 24/12/2025] Trial Registered Prospectively

Last Modified On:

22/12/2025

Post Graduate Thesis

Type of Trial

Interventional

Type of Study

Drug

Study Design

Other

Public Title of Study

A study to test whether vicadrostat (BI 690517) in combination with empagliflozin helps people with heart failure and a weak pumping function of the left side of the heart

Scientific Title of Study

EASi-HF reduced – A Phase III double-blind, randomised, parallel-group superiority trial to evaluate efficacy and safety of the combined use of oral vicadrostat (BI 690517) and empagliflozin compared with placebo and empagliflozin in participants with symptomatic chronic heart failure (HF: NYHA II-IV) and left ventricular ejection fraction (LVEF) less than 40 percent

Trial Acronym

NIL

Secondary IDs if Any

Secondary ID	Identifier
1378-0018 v1.0 dated 14Jan2025	Protocol Number
2024-519525-38-00	EudraCT
U1111-1317-0692	UTN

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name
Designation
Affiliation
Address
Phone
Fax
Email

Details of Contact Person
Scientific Query

Name	Shweta Pradhan
Designation	Head Clinical Operations
Affiliation	IQVIA RDS (India) Private Limited
Address	Omega Embassy Tech Square, Marathahalli - Sarjapura, Outer Ring Road, Kadubeesanahalli Bangalore KARNATAKA 560103 India
Phone	9513774664
Fax
Email	shweta.pradhan@iqvia.com

Details of Contact Person
Public Query

Name	Shweta Pradhan
Designation	Head Clinical Operations
Affiliation	IQVIA RDS (India) Private Limited
Address	Omega Embassy Tech Square, Marathahalli - Sarjapura, Outer Ring Road, Kadubeesanahalli KARNATAKA 560103 India
Phone	9513774664
Fax
Email	shweta.pradhan@iqvia.com

Source of Monetary or Material Support

Boehringer Ingelheim International GmBH

Primary Sponsor

Name	Boehringer Ingelheim International GmbH
Address	Binger Str. 173, 55216 Ingelheim am Rhein, Germany
Type of Sponsor	Pharmaceutical industry-Global

Details of Secondary Sponsor

Name	Address
IQVIA RDS India Pvt Ltd	Omega Embassy Tech Square, Marathahalli-Sarjapur Outer Ring Road, Kadubeesanahalli, Bangalore Karnataka, 560103, India

Countries of Recruitment

Argentina
Belgium
Brazil
Bulgaria
Canada
Chile
China
Colombia
Czech Republic
Denmark
Germany
Hungary
India
Italy
Japan
Mexico
Netherlands
Poland
Republic of Korea
Romania
Saudi Arabia
Serbia
Slovakia
Spain
Taiwan
Turkey
United Kingdom
United States of America
Viet Nam

Sites of Study

No of Sites = 15
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Dr Abraham Oomman	Apollo Hospitals	21, Greams Lane, Off Greams Road 600006 Chennai TAMIL NADU	914428293333 drabrahamoomman@gmail.com
Dr Manojkumar Bhavarilal Chopda	Chopda Medicare & Research Centre Pvt. Ltd	Magnum Heart Institute, 3/5, Patil Lane No. 1, Laxmi Nagar, Near K.B.H. Vidyalaya, Canada Corner 422005 Nashik MAHARASHTRA	02532316200 drchopdamanoj@gmail.com
Dr Ravi Vishnu Prasad	Indira Gandhi Institute of Medical Sciences	Departmen t of Cardiology Sheikhpura - 800014 Patna BIHAR	9431646727 drravivishnuprasad@gmail.com
Dr Saroj Mandal	Institute of Post Graduate Medical Education and Research	244, Acharya Jagadish Chandra Bose Road 700020 Kolkata WEST BENGAL	9831313714 drsarojkumarr@gmail.com
Dr Ajit Raghunath Bhagwat	Kamalnayan Bajaj Hospital	Gut no. ,43, Satara Parisar, Beed bypass Road -431010 Aurangabad MAHARASHTRA	02406632111 drbhagwat.knb@gmail.com
Dr Jenny Madhuri Gudivada	King George hospital, Andhra Medical College	Maharanipeta - 530002 Visakhapatnam ANDHRA PRADESH	7075852341 drjennymadhuriresearch@ gmail.com
Dr Jabir abdullakutty	Lisie Hospital	Dept of cardiology P.B No 3053 - 682018 Ernakulam KERALA	944711773 drjabi@yahoo.co.in
Dr Vijay Kumar Chopra	Max Super Speciality Hospital	(East Block) - A unite of Devki Devi Foundation 2, Press Enclave road Saket 110017 New Delhi DELHI	9650896800 Vijay.chopra@maxhealthcare.com
Dr Sanjay Mittal	Medanta The Medicity	Sector 38 122001 Gurgaon HARYANA	01244141414 sanjay.mittal@medanta.org
Dr Srikanth KV	Narayana Institute of Cardiac Sciences (A unit of Narayana Hrudayalay a Limited)	H Health City, 258/A, Bommasandra Industrial Area, Anekal Taluk - 560099 Bangalore KARNATAKA	9342659468 srikanth.kv.dr01@narayanahealth.org
Dr Atul Damodar Abhyankar	Nirmal Hospital Pvt Ltd	Ring road - 395002 Surat GUJARAT	9824145738 heartfirst.surat@gmail.com
Dr Dinesh Choudhary	S.P. Medical College and A G of Hospitals	Dept of cardiology 334001 Bikaner RAJASTHAN	9414222727 drdineshchoudhary8@gmail.com
Dr Girish Bachhav	Supe Hospital	Opposite Adharashram Gharpure Ghat Near Rungta High School, Ashok Stambh Nashik MAHARASHTRA	7022257367 drgirishbachhav25@gmail.com
Dr Cecily Mary Majella	Tamil Nadu Government Multi Super Specialty Hospital	Omandurar Estate - 600002 Chennai TAMIL NADU	9443584151 drceilym.research@gmail.com
Dr Devang kumar Mahesh chandra Desai	Unicare Heart Institute and Research Center	Acme Plaza, B Wing, Near Sosyo Circle, B/H New Civil Hospital, Canal Road 395002, Surat GUJARAT	9825117900 hridayamHeartcare@gmail.com

Details of Ethics Committee

No of Ethics Committees= 15
Name of Committee	Approval Status
Ethics Committee _Dr. Ajit Raghunath Bhagwat	Submittted/Under Review
Ethics Committee_ Dr. Dinesh Choudhary	Approved
IEC King George hospital_ Dr Jenny Madhuri Gudivada	Approved
Institutional Ethics Committee_ Dr. Abraham Oomman	Approved
Institutional Ethics Committee_ Dr. Cecily Mary Majella	Submittted/Under Review
Institutional ethics Committee_ Dr. Jabir abdullakutty	Submittted/Under Review
Institutional Ethics Committee_ Dr. Ravi Vishnu Prasad	Submittted/Under Review
Institutional Ethics Committee_ Dr.Vijay Kumar Chopra	Submittted/Under Review
IPGMEandR Resaerch Oversight Committee_ Dr. Saroj Mandal	Submittted/Under Review
Magna-Care Ethics Committee_ Dr. Manoj kumar Bhavarilal Chopda	Submittted/Under Review
Medanta Institutional Ethics Committee_ Dr. Sanjay Mittal	Submittted/Under Review
Narayana Health Medical Ethics Committee _Dr. Srikanth. K.V	Submittted/Under Review
Nirmal Hospital Pvt Ltd Ethics Committee_ Dr Atul Damodar Abhyankar	Approved
Supe Hospital Ethics Committee_ Dr. Girish Bachhav	Approved
UNITY HOSPITAL ETHICS COMMITTEE_ Dr. Devang kumar Mahesh chandra Desai	Approved

Regulatory Clearance Status from DCGI

Status

Approved/Obtained

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition: I502\|\|Systolic (congestive) heart failure,

Intervention / Comparator Agent

Type	Name	Details
Intervention	Empagliflozin	Dose: 1 tablet once daily Route: Oral Duration: approximately 12 to 43 months
Comparator Agent	Placebo matching vicadrostat	Dose: 1 tablet once daily Route Oral Duration: approximately 12 to 43 months
Intervention	vicadrostat	Dose: 1 tablet once daily Route: oral Duration: approximately 12 to 43 months

Inclusion Criteria

Age From	18.00 Year(s)
Age To	99.00 Year(s)
Gender	Both
Details	Eligible participants will have a diagnosis of HF with LVEF less than 40 percent and meet eligibility criteria below 1. At least 18 years old and at least at the legal age of consent in countries where it is greater than 18 years 2. Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial 3. Male or female participants. Women of childbearing potential (WOCBP) 1 must be ready and able to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1 percent per year when used consistently and correctly. A list of contraception methods meeting these criteria and instructions on the duration of their use is provided in Section 4.2.2.3. 4. Chronic HF diagnosed at least 3 months before Visit 1, and in NYHA classes II to IV at Visit 1, with LVEF less than 40 percent per local reading (obtained by echocardiography, radionuclide ventriculography, invasive angiography, MRI, or CT). A historical LVEF may be used if it was measured within 12 months prior to Visit 1, or the LVEF may be measured after study consent has been obtained and before randomisation at Visit 2 (if several LVEF assessments are available, the most recent one should be considered). Additional inclusion criteria apply to the optional rhythm monitoring substudy: 1. Willing and able to provide informed consent for substudy participation 2. Sinus rhythm on Visit 1 ECG

ExclusionCriteria

Details

1. Treatment with an MRA (e.g. spironolactone, eplerenone, finerenone) within 14 days
prior to Visit 1 or requiring such treatment before randomisation or planned during the
trial based on the judgment of the investigator. Treatment with an MRA should not be
discontinued with the intention of study enrolment.
2. Treatment with amiloride or other potassium-sparing diuretic within 14 days prior to
Visit 1 or requiring such treatment before randomisation or planned during the trial
based on the judgment of the investigator.
3. Receiving the following treatments:
• A direct renin inhibitor (e.g. aliskiren) at Visit 2
• More than one ACEi, ARB or ARNi used simultaneously at Visit 2
• Other aldosterone synthase inhibitors, e.g. baxdrostat at Visit 2 or planned during the trial
• Systemic mineralocorticoid replacement therapy (e.g. fludrocortisone) at Visit 2
• In case of acute decompensated HF:
o i.v. inotrope, i.v. vasodilating drug (e.g. nitrate, nitroprusside), or i.v. natriuretic peptide (e.g. nesiritide, carperitide), or mechanical support (e.g. intra-aortic balloon pump, endotracheal intubation, mechanical ventilation, any ventricular assist device) within 24 hours prior to randomisation
o i.v. diuretic with a dose that has been increased/intensified within 6 hours prior to randomisation (a stable dose of an i.v. diuretic is not exclusionary)
4. MI, TIA, stroke, coronary artery bypass graft surgery (CABG), heart valve surgery per intervention or any other major surgery (major according to the investigators
assessment) within 90 days prior to Visit 2, or scheduled for major elective surgery (e.g. hip replacement, CABG)
5. Percutaneous coronary intervention (PCI) or any angiography using iodinated contrast
agents in the 7 days prior to Visit 2
6. Heart transplant recipient, awaiting heart transplant, or currently implanted LVAD
7. Known cardiomyopathy based on infiltrative diseases (e.g. amyloidosis), accumulation diseases (e.g. haemochromatosis, Fabry disease), muscular dystrophies, hypertrophic obstructive cardiomyopathy or known pericardial constriction, or cardiomyopathy with potentially reversible cause such as stress or peripartum cardiomyopathy or cardiomyopathy induced by chemotherapy within 12 months prior to Visit 1 and until Visit 2
8. Acute inflammatory heart disease, such as acute myocarditis, within 90 days preceding prior to Visit 1 and until Visit 2 9. Known severe valvular heart disease (obstructive or regurgitant) except mitral regurgitation secondary to left ventricular dilatation, as per investigators judgement, or valvular heart disease scheduled for surgical or invasive procedures at Visit 1, or anticipated invasive treatment during the study
10. Atrial fibrillation or Atrial flutter with a resting pulse rate more than equals to 110 bpm documented by ECG at Visit 2
11. Clinically relevant ventricular arrhythmia neither treated medically nor with a device
with a defibrillator function at Visit 1 and per or Visit 2
12. Unless managed with an implanted pacemaker: symptomatic bradycardia, sick sinus
syndrome, Mobitz Type II second-degree AV block, or third-degree heart block
13. Implantation of CRT device within 3 months prior to Visit 1 or until Visit 2, or scheduled for a CRT device implantation.
14. Symptomatic hypotension and per or a SBP less than 100 mmHg at Visit 1 or Visit 2
15. SBP more than equals to 180 mmHg at Visit 1 or Visit 2. If SBP more than 150 mmHg and less than 180 mmHg at Visit 1, the participant should be receiving at least 3 antihypertensive drugs.
16. Severe chronic pulmonary disease according to investigators judgement, e.g. with
known FEV1 less than 50 percent or need for home oxygen for pulmonary disease, pulmonary arterial hypertension, Chronic Thromboembolic Pulmonary Hypertension (CTEPH), or chronic obstructive pulmonary disease (COPD) exacerbation requiring i.v. or
chronic oral steroids within 3 months prior to Visit 1 or until Visit 2
17. Serum potassium3 more than 5.2 mmol per L measured by the central laboratory at Visit 1 (Note: one reassessment of serum potassium is allowed during screening)
18. ALT or AST3 more than 3x ULN at Visit 1 or known hepatic cirrhosis (Child Pugh C), or other liver disease causing severe impaired liver function, according to investigator’s judgement
19. Impaired renal function, defined as eGFR3 less than 20 mL/min/1.73 m2
(CKD-EPI) as determined at Visit 1 by the central laboratory or on renal replacement therapy (Note: one reassessment of eGFR is allowed during screening)
20. Haemoglobin (Hb)3 less than 9 g per dL as determined at Visit 1 by the central laboratory.
21. Known adrenal insufficiency (e.g. Addison disease) or Cushings syndrome
22. History of ketoacidosis within 5 years prior to Visit 1 or until Visit 2
23. Gastrointestinal surgery or gastrointestinal disorder that could interfere with trial
medication absorption in the investigators opinion, e.g. intestinal resection, inflammatory bowel disease, currently active gastritis, pancreatitis
24. Type 1 diabetes mellitus, or history of other autoimmune causes of diabetes mellitus
(e.g. LADA)
25. Any documented active or suspected malignancy or history of malignancy within 5 years prior to Visit 1, except appropriately treated basal cell carcinoma of the skin, in situ carcinoma of uterine cervix or low risk prostate cancer (participants with pretreatment PSA less than 10 ng per mL and biopsy Gleason score of less than equals to 6 and clinical stage T1c or T2a)
26. Presence of any other disease than heart failure with a life expectancy of less than 1 year in the investigator’s opinion
27. Participants who must or wish to continue the intake of restricted medications (see
Section 4.2.2.1) or any drug considered likely to interfere with the safe conduct of the
trial.
28. Currently enrolled in another investigational device or drug trial, or less than 30 days
or 5 half-lives of the investigational drug (whichever is longer) since ending another investigational device or drug trial(s) or receiving other investigational treatment(s). Those patients participating in a purely observational trial will not be excluded.
29. Chronic alcohol or drug abuse or any condition that, in the investigators opinion, makes them an unreliable trial participant or unlikely to complete the trial
30. Women who are pregnant, breastfeeding, or may become pregnant while in the trial
31. Intolerance or known allergy or hypersensitivity to vicadrostat or empagliflozin or other SGLT2 inhibitors and per or any of the excipients (including lactose). A list of ingredients of vicadrostat and empagliflozin and placebo is provided in the ISF
32. Any condition not covered by any of the other exclusion criteria, including abnormal
laboratory values, which in the investigators opinion, might make a participant otherwise vulnerable (e.g. participant in custody by order of an authority or a court) or jeopardise patient safety or compliance with the protocol.
Additional exclusion criteria apply to the optional rhythm monitoring substudy:
1. Known allergies, intolerance or hypersensitivities to adhesives or hydrogel
2. Cardiac pacemaker, ICD, or CRT device
3. History of permanent atrial fibrillation or atrial flutter

Method of Generating Random Sequence

Other

Method of Concealment

Other

Blinding/Masking

Participant and Investigator Blinded

Primary Outcome

Outcome	TimePoints
Time to first event of: 1)Hospitalization due to heart failure (HHF) 2)Cardiovascular (CV) death 3)Urgent heart failure (HF) visit event of CV death, hospitalization for heart failure (HHF) or urgent HF visit in participants with HF and LVEF less than 40 percent not taking MRA.	week 32 and week 52

Secondary Outcome

Outcome

TimePoints

Absolute change from baseline in Kansas City Cardiomyopathy Questionnaire-Total Symptom Score (KCCQ-TSS) at Week 32
Time to all-cause mortality.
Absolute change from baseline in Kansas City Cardiomyopathy Questionnaire-Total Symptom Score (KCCQ-TSS) at Week 52.
Absolute change from baseline in systolic blood pressure (SBP) [mmHg] at Week 32 in participants with baseline SBP more than equals to130 mmHg
Absolute change from baseline in diastolic blood pressure (DBP) [mmHg] at Week 32 in participants with baseline DBP more than equals to 80 mmHg.
Change in NYHA class from baseline to Weeks 32 & 52

week 32

Target Sample Size

Total Sample Size="4200"
Sample Size from India="100"
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)

22/01/2026

Date of Study Completion (India)

Applicable only for Completed/Terminated trials

Date of First Enrollment (Global)

05/06/2025

Date of Study Completion (Global)

Applicable only for Completed/Terminated trials

Estimated Duration of Trial

Years="3"
Months="6"
Days="0"

Recruitment Status of Trial (Global)

Open to Recruitment

Recruitment Status of Trial (India)

Not Yet Recruiting

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

Regardless of recent treatment advances in the management of HF, the residual risk for cardiovascular death, hospitalisation for heart failure and impaired quality of life remains substantial in patients with HF, which is applicable also to patients with LVEF less than 40 percent. The combination of vicadrostat and empagliflozin may achieve an additive or synergistic beneficial effect on HF outcomes. Therefore, the aim of this trial is to investigate the efficacy and safety of the combined use of vicadrostat and empagliflozin compared with placebo and empagliflozin in participants with symptomatic heart failure (HF: NYHA II-IV) and LVEF less than 40 percent.