Study to Evaluate Safety, Tolerability and Drug Levels of BMS-986435/MYK-224 in Participants With Heart Failure With Preserved Ejection Fraction (HFpEF)

NCT06122779 | Recruiting Phase 2 FDA Drug

• 3 other identifiers: CV029-10012023-505919-21U1111-1292-8451
• Study Type: interventional
• Target: 208
• Locations: 11 countries
• Sites: 117

Brief Summary

The purpose of this study is to evaluate the safety, tolerability, and exposure-response (E-R) of BMS-986435/MYK-224 in participants with symptomatic Heart Failure with Preserved Ejection Fraction (HFpEF).

Conditions

Heart Failure

Keywords

BMS-986435; MYK-224; Pharmacokinetics; Pharmacodynamics; Safety; HFpEF

Outcome Measures

Primary Outcomes (3)

• Incidence of treatment emergent adverse events (TEAEs)

  Up to approximately 24 weeks

• Incidence of serious adverse events (SAEs)

  Up to approximately 24 weeks

• Incidence of AEs leading to treatment discontinuation

  Up to approximately 20 weeks

Secondary Outcomes (1)

• Summary of plasma concentrations of MYK-224

  Up to approximately 20 weeks

Study Arms (2)

BMS-986435

EXPERIMENTAL

Drug: BMS-986435

Placebo

PLACEBO COMPARATOR

Other: Placebo

Interventions

Placebo OTHER

Specified dose on specified days

Placebo

BMS-986435 DRUG

Specified dose on specified days

Also known as: MYK-224

BMS-986435

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Adult participants with stable, symptomatic HFpEF with a normal heart pumping ability.

You may not qualify if:

• Participants must not have a known diagnosis of obstructive or genetic hypertrophic cardiomyopathy or infiltrative/storage disorder such as cardiac amyloidosis, or any other acute or serious condition that could interfere with assessments during the study or may pose a risk to the participant.

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (117)

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

RECRUITING

Colorado Heart and Vascular - Lakewood

Lakewood, Colorado, 80228-1710, United States

RECRUITING

Ascension St. Vincent's Riverside Hospital - PPDS

Jacksonville, Florida, 32204-4748, United States

RECRUITING

Local Institution - 0003

Miami, Florida, 33133-4223, United States

ACTIVE NOT RECRUITING

University of Miami FL Miller School of Medicine -1120 NW 14th St

Miami, Florida, 33136-2107, United States

RECRUITING

Local Institution - 0014

Atlanta, Georgia, 30322-1013, United States

WITHDRAWN

Local Institution - 0048

Atlanta, Georgia, 30322-1013, United States

WITHDRAWN

Bluhm Cardiovascular Institute of Northwestern

Chicago, Illinois, 60611-5969, United States

RECRUITING

Chicago Medical Research, LLC - Hazel Crest

Hazel Crest, Illinois, 60429-2196, United States

RECRUITING

Ascension Medical Group St. Vincent - Indianapolis Heart Care

Indianapolis, Indiana, 46260-1992, United States

RECRUITING

Local Institution - 0045

Indianapolis, Indiana, 46260-1992, United States

WITHDRAWN

St. Louis Heart and Vascular

St Louis, Missouri, 63136-6111, United States

RECRUITING

Local Institution - 0043

St Louis, Missouri, 63136, United States

WITHDRAWN

Local Institution - 0117

Hackensack, New Jersey, 07601, United States

NOT YET RECRUITING

Capital Cardiology Associates

Albany, New York, 12211, United States

RECRUITING

Local Institution - 0105

Brooklyn, New York, 11215, United States

NOT YET RECRUITING

Weill Cornell Medicine

New York, New York, 10065-4805, United States

RECRUITING

University of Rochester Medical Center - PPDS

Rochester, New York, 14618-2668, United States

RECRUITING

Rochester General Hospital Center for Clinical Research

Rochester, New York, 14621, United States

RECRUITING

Laurelton Heart Specialist PC - MyClinical - PPDS

Rosedale, New York, 11422-1320, United States

RECRUITING

Duke Cardiology Clinic - PPDS

Durham, North Carolina, 27710-4000, United States

RECRUITING

Local Institution - 0058

Cincinnati, Ohio, 45242, United States

WITHDRAWN

Local Institution - 0041

Oklahoma City, Oklahoma, 73135-2607, United States

WITHDRAWN

South Oklahoma Heart Research

Oklahoma City, Oklahoma, 73135-2607, United States

RECRUITING

Abington Memorial Hospital

Abington, Pennsylvania, 19001, United States

RECRUITING

Tennessee Center for Clinical Trials

Tullahoma, Tennessee, 37388-8260, United States

RECRUITING

Local Institution - 0104

Austin, Texas, 78756-4080, United States

NOT YET RECRUITING

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

RECRUITING

Angiocardiac Care of Texas - PA - PPDS

Houston, Texas, 77025-5253, United States

RECRUITING

Local Institution - 0051

Houston, Texas, 77025-5253, United States

WITHDRAWN

Local Institution - 0066

Falls Church, Virginia, 22042-1262, United States

WITHDRAWN

Corporación Médica de General San Martín

Ciudad del Libertador General San Martín, Buenos Aires, B1650BNB, Argentina

RECRUITING

Local Institution - 0107

Zárate, Buenos Aires, B2800DGH, Argentina

WITHDRAWN

Local Institution - 0115

Zárate, Buenos Aires, B2800DGH, Argentina

NOT YET RECRUITING

Local Institution - 0090

Córdoba, Córdoba Province, X5000AAX, Argentina

NOT YET RECRUITING

Local Institution - 0053

Córdoba, Córdoba Province, X5003DCE, Argentina

NOT YET RECRUITING

Local Institution - 0073

Rosario, Santa Fe Province, S2000DSR, Argentina

NOT YET RECRUITING

IPR-Investigaciones en Patologías Respiratorias

San Miguel de Tucumán, Tucumán Province, T4000IAP, Argentina

RECRUITING

Centro de Especialidades Médicas CEMEDIC

Buenos Aires, 1407, Argentina

RECRUITING

Local Institution - 0068

Buenos Aires, C1179AAB, Argentina

WITHDRAWN

Local Institution - 0067

Buenos Aires, C1431FWO, Argentina

NOT YET RECRUITING

Sanatorio Duarte Quiros

Córdoba, X5000AOQ, Argentina

RECRUITING

Local Institution - 0069

Salta, A4406BPF, Argentina

NOT YET RECRUITING

Centro de Investigaciones Clínicas Del Litoral SRL

Santa Fe, S3000FWO, Argentina

RECRUITING

Hamilton General Hospital

Hamilton, Ontario, L8L 2X2, Canada

RECRUITING

Medicus MFC Inc.

Toronto, Ontario, M4P 1E4, Canada

RECRUITING

Local Institution - 0030

Toronto, Ontario, M5S 1B2, Canada

WITHDRAWN

Local Institution - 0040

Toronto, Ontario, M5S 1B2, Canada

WITHDRAWN

Local Institution - 0011

Montreal, Quebec, H1T 1C8, Canada

WITHDRAWN

Local Institution - 0035

Trois-Rivières, Quebec, G9A 1Y1, Canada

WITHDRAWN

Peking Union Medical College Hospital - East Campus

Beijing, Beijing Municipality, 100730, China

RECRUITING

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, 510120, China

RECRUITING

The First Affiliated Hospital of Henan Science and Technology University - Jinghua Campus

Luoyang, Henan, 471003, China

RECRUITING

The Second Xiangya Hospital of Central South University

Changsha, Hunan, 410011, China

RECRUITING

The Second Affiliated Hospital, Zhejiang University School of Medicine - Jiefanglu Campus

Hangzhou, Zhejiang, 310009, China

RECRUITING

Local Institution - 0109

Jerusalem, Jerusalem, 90000, Israel

NOT YET RECRUITING

Local Institution - 0113

Jerusalem, Jerusalem, 9103102, Israel

NOT YET RECRUITING

Local Institution - 0111

Beersheba, 84101, Israel

NOT YET RECRUITING

Local Institution - 0112

Be’er Ya‘aqov, 7033001, Israel

NOT YET RECRUITING

Local Institution - 0108

Haifa, 3109601, Israel

NOT YET RECRUITING

Local Institution - 0110

Petah Tikva, 49100, Israel

NOT YET RECRUITING

Local Institution - 0106

Rehovot, 76100, Israel

NOT YET RECRUITING

Local Institution - 0116

Safed, 13100, Israel

NOT YET RECRUITING

Local Institution - 0027

Foggia, Apulia, 71100, Italy

WITHDRAWN

Local Institution - 0038

Foggia, Apulia, 71100, Italy

WITHDRAWN

Local Institution - 0019

Naples, Campania, 80131, Italy

COMPLETED

Local Institution - 0023

Milan, Lombardy, 20162, Italy

WITHDRAWN

Local Institution - 0033

Milan, Lombardy, 20162, Italy

WITHDRAWN

IRCCS Policlinico San Donato

San Donato Milanese, Lombardy, 20097, Italy

RECRUITING

Local Institution - 0050

San Donato Milanese, Lombardy, 20097, Italy

WITHDRAWN

Local Institution - 0052

Massa, Tuscany, 54100, Italy

WITHDRAWN

Local Institution - 0009

Bergamo, 24127, Italy

COMPLETED

Local Institution - 0017

Pisa, 56124, Italy

COMPLETED

Hyogo Prefectural Harima-Himeji General Medical Center

Himeji-Shi, Hyōgo, 672-8044, Japan

RECRUITING

National Hospital Organization Kanazawa Medical Center

Kanazawa, Ishikawa-ken, 920-8650, Japan

RECRUITING

Okayama Rosai Hospital

Okayama, Okayama-ken, 702-8055, Japan

RECRUITING

Kishiwada Tokushukai Hospital

Kishiwada, Osaka, 596-0042, Japan

RECRUITING

Takatsuki Red Cross Hospital

Takatsuki-Shi, Osaka, 569-1045, Japan

RECRUITING

Clinical Trials UMED Sp. z o.o.

Lódz, Lódzkie, 92-213, Poland

RECRUITING

Local Institution - 0031

Bialystok, Podlaskie Voivodeship, 15-276, Poland

COMPLETED

Local Institution - 0044

Bialystok, Podlaskie Voivodeship, 15-276, Poland

WITHDRAWN

Local Institution - 0020

Lublin, Woj. Lubelskie, 20090, Poland

WITHDRAWN

Local Institution - 0049

Lublin, Woj. Lubelskie, 20090, Poland

WITHDRAWN

Local Institution - 0006

Krakow, 30-082, Poland

WITHDRAWN

Local Institution - 0024

Oświęcim, 51162, Poland

WITHDRAWN

Chungnam National University Hospital

Daejeon, Daejeon Gwang'yeogsi, 35015, South Korea

RECRUITING

Inha University Hospital

Junggu, Incheon Gwang'yeogsi, 22332, South Korea

RECRUITING

Severance Hospital Yonsei University Health System

Seoul, Seoul Teugbyeolsi, 03722, South Korea

RECRUITING

The Catholic University of Korea, Seoul St. Mary's Hospital

Seoul, Seoul Teugbyeolsi, 06591, South Korea

RECRUITING

Samsung Medical Center

Seoul, Seoul Teugbyeolsi, 6351, South Korea

RECRUITING

Pusan National University Hospital

Busan, 49241, South Korea

RECRUITING

Keimyung University Dongsan Hospital

Daegu, 42601, South Korea

RECRUITING

Chonnam National University Hospital

Gwangju, 61469, South Korea

RECRUITING

Seoul National University Bundang Hospital

Seongnam-si, 0, South Korea

RECRUITING

Seoul National University Hospital

Seoul, 03080, South Korea

RECRUITING

Local Institution - 0012

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

COMPLETED

Local Institution - 0025

Majadahonda, Madrid, 28222, Spain

COMPLETED

Local Institution - 0047

Majadahonda, Madrid, 28222, Spain

WITHDRAWN

Hospital Universitario Virgen de La Arrixaca

El Palmar, Murcia, 30120, Spain

RECRUITING

Local Institution - 0039

El Palmar, Murcia, 30120, Spain

WITHDRAWN

Local Institution - 0042

Málaga, Málaga, 29010, Spain

WITHDRAWN

Local Institution - 0026

Madrid, 28034, Spain

COMPLETED

Local Institution - 0034

Madrid, 28034, Spain

WITHDRAWN

Local Institution - 0032

Málaga, 29010, Spain

ACTIVE NOT RECRUITING

Hospital Nuestra Señora de Valme

Seville, 41014, Spain

RECRUITING

Local Institution - 0046

Seville, 41014, Spain

WITHDRAWN

Local Institution - 0010

Valencia, 46010, Spain

COMPLETED

Northwick Park Hospital

Harrow, Greater London, HA1 3UJ, United Kingdom

RECRUITING

North Tyneside General Hospital

North Shields, Northumberland, NE29 8NH, United Kingdom

RECRUITING

Leeds General Infirmary - PPDS

Leeds, Yorkshire, LS1 3EX, United Kingdom

RECRUITING

Local Institution - 0057

Sheffield, Yorkshire, S5 7AU, United Kingdom

WITHDRAWN

Bristol Royal Infirmary

Bristol, BS2 8HW, United Kingdom

RECRUITING

Local Institution - 0097

Dundee, DD1 9SY, United Kingdom

NOT YET RECRUITING

Local Institution - 0075

London, SE1 7EH, United Kingdom

NOT YET RECRUITING

John Radcliffe Hospital

Oxford, OX3 9DU, United Kingdom

RECRUITING

University Hospital of North Tees

Stockton-on-Tees, TS19 8PE, United Kingdom

RECRUITING

New Cross Hospital

Wolverhampton, WV10 0QP, United Kingdom

RECRUITING

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Central Study Contacts

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

CONTACT

855-907-3286; Clinical.Trials@bms.com

First line of the email MUST contain NCT # and Site #.

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2023
• First Posted: November 8, 2023
• Study Start: November 7, 2023
• Primary Completion (Estimated): July 3, 2026
• Study Completion (Estimated): July 3, 2026
• Last Updated: December 15, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: See Plan Description
• Access Criteria: See Plan Description

Locations

IL (8); GB (10); JP (5); AR (13); KR (10); CA (6); ES (12); IT (10); US (31); PL (7); CN (5)