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

NCT ID: NCT06122779

Last Updated: 2025-11-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

208 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-07

Study Completion Date

2026-07-03

Brief Summary

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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).

Detailed Description

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Conditions

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Heart Failure

Keywords

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BMS-986435 MYK-224 Pharmacokinetics Pharmacodynamics Safety HFpEF

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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BMS-986435

Group Type EXPERIMENTAL

BMS-986435

Intervention Type DRUG

Specified dose on specified days

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Specified dose on specified days

Interventions

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BMS-986435

Specified dose on specified days

Intervention Type DRUG

Placebo

Specified dose on specified days

Intervention Type OTHER

Other Intervention Names

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MYK-224

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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.
Minimum Eligible Age

40 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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University of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status RECRUITING

Colorado Heart and Vascular - Lakewood

Lakewood, Colorado, United States

Site Status RECRUITING

Ascension St. Vincent's Riverside Hospital - PPDS

Jacksonville, Florida, United States

Site Status RECRUITING

Local Institution - 0003

Miami, Florida, United States

Site Status ACTIVE_NOT_RECRUITING

Local Institution - 0099

Miami, Florida, United States

Site Status NOT_YET_RECRUITING

Local Institution - 0014

Atlanta, Georgia, United States

Site Status WITHDRAWN

Local Institution - 0048

Atlanta, Georgia, United States

Site Status WITHDRAWN

Bluhm Cardiovascular Institute of Northwestern

Chicago, Illinois, United States

Site Status RECRUITING

Chicago Medical Research, LLC - Hazel Crest

Hazel Crest, Illinois, United States

Site Status RECRUITING

Ascension Medical Group St. Vincent - Indianapolis Heart Care

Indianapolis, Indiana, United States

Site Status RECRUITING

Local Institution - 0045

Indianapolis, Indiana, United States

Site Status WITHDRAWN

St. Louis Heart and Vascular

St Louis, Missouri, United States

Site Status RECRUITING

Local Institution - 0043

St Louis, Missouri, United States

Site Status WITHDRAWN

Local Institution - 0117

Hackensack, New Jersey, United States

Site Status NOT_YET_RECRUITING

Capital Cardiology Associates

Albany, New York, United States

Site Status RECRUITING

Local Institution - 0105

Brooklyn, New York, United States

Site Status NOT_YET_RECRUITING

Weill Cornell Medicine

New York, New York, United States

Site Status RECRUITING

University of Rochester Medical Center - PPDS

Rochester, New York, United States

Site Status RECRUITING

Rochester General Hospital Center for Clinical Research

Rochester, New York, United States

Site Status RECRUITING

Laurelton Heart Specialist PC - MyClinical - PPDS

Rosedale, New York, United States

Site Status RECRUITING

Local Institution - 0095

Durham, North Carolina, United States

Site Status NOT_YET_RECRUITING

Local Institution - 0058

Cincinnati, Ohio, United States

Site Status WITHDRAWN

Local Institution - 0041

Oklahoma City, Oklahoma, United States

Site Status WITHDRAWN

South Oklahoma Heart Research

Oklahoma City, Oklahoma, United States

Site Status RECRUITING

Abington Memorial Hospital

Abington, Pennsylvania, United States

Site Status RECRUITING

Tennessee Center for Clinical Trials

Tullahoma, Tennessee, United States

Site Status RECRUITING

Local Institution - 0104

Austin, Texas, United States

Site Status NOT_YET_RECRUITING

University of Texas Southwestern Medical Center

Dallas, Texas, United States

Site Status RECRUITING

Angiocardiac Care of Texas - PA - PPDS

Houston, Texas, United States

Site Status RECRUITING

Local Institution - 0051

Houston, Texas, United States

Site Status WITHDRAWN

Local Institution - 0066

Falls Church, Virginia, United States

Site Status WITHDRAWN

Local Institution - 0054

Ciudad del Libertador General San Martín, Buenos Aires, Argentina

Site Status NOT_YET_RECRUITING

Local Institution - 0107

Zárate, Buenos Aires, Argentina

Site Status WITHDRAWN

Local Institution - 0115

Zárate, Buenos Aires, Argentina

Site Status NOT_YET_RECRUITING

Local Institution - 0090

Córdoba, Córdoba Province, Argentina

Site Status NOT_YET_RECRUITING

Local Institution - 0053

Córdoba, Córdoba Province, Argentina

Site Status NOT_YET_RECRUITING

Local Institution - 0073

Rosario, Santa Fe Province, Argentina

Site Status NOT_YET_RECRUITING

IPR-Investigaciones en Patologías Respiratorias

San Miguel de Tucumán, Tucumán Province, Argentina

Site Status RECRUITING

Centro de Especialidades Médicas CEMEDIC

Buenos Aires, , Argentina

Site Status RECRUITING

Local Institution - 0068

Buenos Aires, , Argentina

Site Status WITHDRAWN

Local Institution - 0067

Buenos Aires, , Argentina

Site Status NOT_YET_RECRUITING

Sanatorio Duarte Quiros

Córdoba, , Argentina

Site Status RECRUITING

Local Institution - 0069

Salta, , Argentina

Site Status NOT_YET_RECRUITING

Local Institution - 0102

Santa Fe, , Argentina

Site Status NOT_YET_RECRUITING

Hamilton General Hospital

Hamilton, Ontario, Canada

Site Status RECRUITING

Medicus MFC Inc.

Toronto, Ontario, Canada

Site Status RECRUITING

Local Institution - 0030

Toronto, Ontario, Canada

Site Status WITHDRAWN

Local Institution - 0040

Toronto, Ontario, Canada

Site Status WITHDRAWN

Local Institution - 0011

Montreal, Quebec, Canada

Site Status WITHDRAWN

Local Institution - 0035

Trois-Rivières, Quebec, Canada

Site Status WITHDRAWN

Peking Union Medical College Hospital - East Campus

Beijing, Beijing Municipality, China

Site Status RECRUITING

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, China

Site Status RECRUITING

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

Luoyang, Henan, China

Site Status RECRUITING

The Second Xiangya Hospital of Central South University

Changsha, Hunan, China

Site Status RECRUITING

The Second Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Site Status RECRUITING

Local Institution - 0109

Jerusalem, Jerusalem, Israel

Site Status NOT_YET_RECRUITING

Local Institution - 0113

Jerusalem, Jerusalem, Israel

Site Status NOT_YET_RECRUITING

Local Institution - 0111

Beersheba, , Israel

Site Status NOT_YET_RECRUITING

Local Institution - 0112

Be’er Ya‘aqov, , Israel

Site Status NOT_YET_RECRUITING

Local Institution - 0108

Haifa, , Israel

Site Status NOT_YET_RECRUITING

Local Institution - 0110

Petah Tikva, , Israel

Site Status NOT_YET_RECRUITING

Local Institution - 0106

Rehovot, , Israel

Site Status NOT_YET_RECRUITING

Local Institution - 0116

Safed, , Israel

Site Status NOT_YET_RECRUITING

Local Institution - 0027

Foggia, Apulia, Italy

Site Status WITHDRAWN

Local Institution - 0038

Foggia, Apulia, Italy

Site Status WITHDRAWN

Local Institution - 0019

Napoli, Campania, Italy

Site Status COMPLETED

Local Institution - 0023

Milan, Lombardy, Italy

Site Status WITHDRAWN

Local Institution - 0033

Milan, Lombardy, Italy

Site Status WITHDRAWN

IRCCS Policlinico San Donato

San Donato Milanese, Lombardy, Italy

Site Status RECRUITING

Local Institution - 0050

San Donato Milanese, Lombardy, Italy

Site Status WITHDRAWN

Local Institution - 0052

Massa, Tuscany, Italy

Site Status WITHDRAWN

Local Institution - 0009

Bergamo, , Italy

Site Status COMPLETED

Local Institution - 0017

Pisa, , Italy

Site Status COMPLETED

Hyogo Prefectural Harima-Himeji General Medical Center

Himeji-Shi, Hyōgo, Japan

Site Status RECRUITING

National Hospital Organization Kanazawa Medical Center

Kanazawa, Ishikawa-ken, Japan

Site Status RECRUITING

Okayama Rosai Hospital

Okayama, Okayama-ken, Japan

Site Status RECRUITING

Kishiwada Tokushukai Hospital

Kishiwada, Osaka, Japan

Site Status RECRUITING

Takatsuki Red Cross Hospital

Takatsuki-Shi, Osaka, Japan

Site Status RECRUITING

Clinical Trials UMED Sp. z o.o.

Lódz, Lódzkie, Poland

Site Status RECRUITING

Local Institution - 0031

Bialystok, Podlaskie Voivodeship, Poland

Site Status COMPLETED

Local Institution - 0044

Bialystok, Podlaskie Voivodeship, Poland

Site Status WITHDRAWN

Local Institution - 0020

Lublin, Woj. Lubelskie, Poland

Site Status WITHDRAWN

Local Institution - 0049

Lublin, Woj. Lubelskie, Poland

Site Status WITHDRAWN

Local Institution - 0006

Krakow, , Poland

Site Status WITHDRAWN

Local Institution - 0024

Oświęcim, , Poland

Site Status WITHDRAWN

Chungnam National University Hospital

Daejeon, Daejeon Gwang'yeogsi, South Korea

Site Status RECRUITING

Inha University Hospital

Junggu, Incheon Gwang'yeogsi, South Korea

Site Status RECRUITING

Severance Hospital Yonsei University Health System

Seoul, Seoul Teugbyeolsi, South Korea

Site Status RECRUITING

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

Seoul, Seoul Teugbyeolsi, South Korea

Site Status RECRUITING

Samsung Medical Center

Seoul, Seoul Teugbyeolsi, South Korea

Site Status RECRUITING

Pusan National University Hospital

Busan, , South Korea

Site Status RECRUITING

Keimyung University Dongsan Hospital

Daegu, , South Korea

Site Status RECRUITING

Chonnam National University Hospital

Gwangju, , South Korea

Site Status RECRUITING

Local Institution - 0098

Seongnam-si, , South Korea

Site Status NOT_YET_RECRUITING

Seoul National University Hospital

Seoul, , South Korea

Site Status RECRUITING

Local Institution - 0012

L'Hospitalet de Llobregat, Barcelona, Spain

Site Status COMPLETED

Local Institution - 0025

Majadahonda, Madrid, Spain

Site Status COMPLETED

Local Institution - 0047

Majadahonda, Madrid, Spain

Site Status WITHDRAWN

Hospital Universitario Virgen de La Arrixaca

El Palmar, Murcia, Spain

Site Status RECRUITING

Local Institution - 0039

El Palmar, Murcia, Spain

Site Status WITHDRAWN

Local Institution - 0042

Málaga, Málaga, Spain

Site Status WITHDRAWN

Local Institution - 0026

Madrid, , Spain

Site Status COMPLETED

Local Institution - 0034

Madrid, , Spain

Site Status WITHDRAWN

Local Institution - 0032

Málaga, , Spain

Site Status ACTIVE_NOT_RECRUITING

Hospital Nuestra Señora de Valme

Seville, , Spain

Site Status RECRUITING

Local Institution - 0046

Seville, , Spain

Site Status WITHDRAWN

Local Institution - 0010

Valencia, , Spain

Site Status COMPLETED

Northwick Park Hospital

Harrow, Greater London, United Kingdom

Site Status RECRUITING

North Tyneside General Hospital

North Shields, Northumberland, United Kingdom

Site Status RECRUITING

Local Institution - 0072

Leeds, Yorkshire, United Kingdom

Site Status NOT_YET_RECRUITING

Local Institution - 0057

Sheffield, Yorkshire, United Kingdom

Site Status WITHDRAWN

Bristol Royal Infirmary

Bristol, , United Kingdom

Site Status RECRUITING

Local Institution - 0097

Dundee, , United Kingdom

Site Status NOT_YET_RECRUITING

Local Institution - 0075

London, , United Kingdom

Site Status NOT_YET_RECRUITING

John Radcliffe Hospital

Oxford, , United Kingdom

Site Status RECRUITING

Local Institution - 0065

Stockton-on-Tees, , United Kingdom

Site Status NOT_YET_RECRUITING

New Cross Hospital

Wolverhampton, , United Kingdom

Site Status RECRUITING

Countries

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United States Argentina Canada China Israel Italy Japan Poland South Korea Spain United Kingdom

Central Contacts

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BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

Role: CONTACT

Phone: 855-907-3286

Email: [email protected]

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

Role: CONTACT

Facility Contacts

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Pankaj Arora, Site 0002

Role: primary

McHale Anderson, Site 0096

Role: primary

Nima Taghipour, Site 0077

Role: primary

Site 0099

Role: primary

Ravi Patel, Site 0004

Role: primary

Suhail Khadra, Site 0005

Role: primary

Ashwin Ravichandran, Site 0029

Role: primary

Harvey Serota, Site 0028

Role: primary

Site 0117

Role: primary

Eugene Pashkovetsky, Site 0070

Role: primary

Site 0105

Role: primary

Parag Goyal, Site 0008

Role: primary

Christopher Cove, Site 0059

Role: primary

Vishal Parikh, Site 0076

Role: primary

Olakunle Akinboboye, Site 0094

Role: primary

Site 0095

Role: primary

Naeem Tahirkheli, Site 0016

Role: primary

Donald Haas, Site 0078

Role: primary

Dinesh Gupta, Site 0001

Role: primary

Site 0104

Role: primary

Ambarish Pandey, Site 0036

Role: primary

Amin Karim, Site 0015

Role: primary

Site 0054

Role: primary

Site 0115

Role: primary

Site 0090

Role: primary

Site 0053

Role: primary

Site 0073

Role: primary

Lilia Luz Lobo Marquez, Site 0061

Role: primary

Claudio Majul, Site 0060

Role: primary

Site 0067

Role: primary

Hugo Colombo, Site 0074

Role: primary

Site 0069

Role: primary

Site 0102

Role: primary

Catherine Demers, Site 0007

Role: primary

Gordon Moe, Site 0037

Role: primary

Zhuang Tian, Site 0089

Role: primary

Zhicheng Jing, Site 0087

Role: primary

Laijing Du, Site 0080

Role: primary

Daoquan Peng, Site 0079

Role: primary

JianAn Wang, Site 0082

Role: primary

Site 0109

Role: primary

Site 0113

Role: primary

Site 0111

Role: primary

Site 0112

Role: primary

Site 0108

Role: primary

Site 0110

Role: primary

Site 0106

Role: primary

Site 0116

Role: primary

Massimo Piepoli, Site 0022

Role: primary

Tomofumi Takaya, Site 0092

Role: primary

Takahiro Saeki, Site 0100

Role: primary

Mitsuru Munemasa, Site 0091

Role: primary

Satoshi Kuroyanagi, Site 0093

Role: primary

Haruhiko Onaka, Site 0103

Role: primary

Jaroslaw Drozdz, Site 0013

Role: primary

Jae-Hyeong Park, Site 0084

Role: primary

Sung-Hee Shin, Site 0056

Role: primary

Seok-Min Kang, Site 0085

Role: primary

Jong-Chan Youn, Site 0055

Role: primary

Sang-Chol Lee, Site 0114

Role: primary

Jung-Hyun Choi, Site 0086

Role: primary

Incheol Kim, Site 0088

Role: primary

Kye Hun Kim, Site 0083

Role: primary

Site 0098

Role: primary

Hyung-Kwan Kim, Site 0081

Role: primary

Domingo Pascual-Figal, Site 0021

Role: primary

Antonio Reyes Dominguez, Site 0018

Role: primary

Jaymin Shah, Site 0063

Role: primary

Thomas Green, Site 0071

Role: primary

Site 0072

Role: primary

Eva Sammut, Site 0101

Role: primary

Site 0097

Role: primary

Site 0075

Role: primary

Andrew Lewis, Site 0062

Role: primary

Site 0065

Role: primary

Sandeep Hothi, Site 0064

Role: primary

Related Links

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Other Identifiers

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2023-505919-21

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

U1111-1292-8451

Identifier Type: OTHER

Identifier Source: secondary_id

CV029-1001

Identifier Type: -

Identifier Source: org_study_id