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

NCT06122779 | Active Not Recruiting Phase 2 FDA Drug

• 3 other identifiers: CV029-10012023-505919-21U1111-1292-8451
• Study Type: interventional
• Target: 227
• Locations: 11 countries
• Sites: 86

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 (86)

Local Institution - 0002

Birmingham, Alabama, 35233, United States

Location

Local Institution - 0096

Lakewood, Colorado, 80228-1710, United States

Location

Local Institution - 0077

Jacksonville, Florida, 32204-4748, United States

Location

Local Institution - 0003

Miami, Florida, 33133-4223, United States

Location

Local Institution - 0099

Miami, Florida, 33136-2107, United States

Location

Local Institution - 0004

Chicago, Illinois, 60611-5969, United States

Location

Local Institution - 0005

Hazel Crest, Illinois, 60429-2196, United States

Location

Local Institution - 0029

Indianapolis, Indiana, 46260-1992, United States

Location

Local Institution - 0028

St Louis, Missouri, 63136-6111, United States

Location

Local Institution - 0117

Hackensack, New Jersey, 07601-1915, United States

Location

Local Institution - 0070

Albany, New York, 12211, United States

Location

Local Institution - 0105

Brooklyn, New York, 11215, United States

Location

Local Institution - 0008

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

Location

Local Institution - 0059

Rochester, New York, 14618-2668, United States

Location

Local Institution - 0076

Rochester, New York, 14621, United States

Location

Local Institution - 0094

Rosedale, New York, 11422-1320, United States

Location

Local Institution - 0095

Durham, North Carolina, 27710-4000, United States

Location

Local Institution - 0016

Oklahoma City, Oklahoma, 73135-2607, United States

Location

Local Institution - 0078

Abington, Pennsylvania, 19001, United States

Location

Local Institution - 0001

Tullahoma, Tennessee, 37388-8260, United States

Location

Local Institution - 0104

Austin, Texas, 78756-4080, United States

Location

Local Institution - 0036

Dallas, Texas, 75390, United States

Location

Local Institution - 0015

Houston, Texas, 77025-5253, United States

Location

Local Institution - 0054

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

Location

Local Institution - 0115

Zárate, Buenos Aires, B2800DGH, Argentina

Location

Local Institution - 0090

Córdoba, Córdoba Province, 5000, Argentina

Location

Local Institution - 0053

Córdoba, Córdoba Province, X5003DCE, Argentina

Location

Local Institution - 0073

Rosario, Santa Fe Province, 2000, Argentina

Location

Local Institution - 0061

San Miguel de Tucumán, Tucumán Province, T4000IAP, Argentina

Location

Local Institution - 0060

Buenos Aires, 1407, Argentina

Location

Local Institution - 0067

Buenos Aires, C1431FWO, Argentina

Location

Local Institution - 0074

Córdoba, X5000AOQ, Argentina

Location

Local Institution - 0069

Salta, A4406BPF, Argentina

Location

Local Institution - 0102

Santa Fe, S3000FWO, Argentina

Location

Local Institution - 0007

Hamilton, Ontario, L8L 2X2, Canada

Location

Local Institution - 0037

Toronto, Ontario, M4P 1E4, Canada

Location

Local Institution - 0089

Beijing, Beijing Municipality, 100730, China

Location

Local Institution - 0087

Guangzhou, Guangdong, 510120, China

Location

Local Institution - 0080

Luoyang, Henan, 471003, China

Location

Local Institution - 0079

Changsha, Hunan, 410011, China

Location

Local Institution - 0082

Hangzhou, Zhejiang, 310009, China

Location

Local Institution - 0109

Jerusalem, Jerusalem, 90000, Israel

Location

Local Institution - 0111

Beersheba, 84101, Israel

Location

Local Institution - 0112

Be’er Ya‘aqov, 7033001, Israel

Location

Local Institution - 0108

Haifa, 3109601, Israel

Location

Local Institution - 0113

Jerusalem, 9103102, Israel

Location

Local Institution - 0110

Petah Tikva, 49100, Israel

Location

Local Institution - 0106

Rehovot, 76100, Israel

Location

Local Institution - 0116

Safed, 1311001, Israel

Location

Local Institution - 0019

Naples, Campania, 80131, Italy

Location

Local Institution - 0022

San Donato Milanese, Lombardy, 20097, Italy

Location

Local Institution - 0017

Pisa, Tuscany, 56126, Italy

Location

Local Institution - 0009

Bergamo, 24127, Italy

Location

Local Institution - 0092

Himeji-Shi, Hyōgo, 672-8044, Japan

Location

Local Institution - 0100

Kanazawa, Ishikawa-ken, 920-8650, Japan

Location

Local Institution - 0091

Okayama, Okayama-ken, 702-8055, Japan

Location

Local Institution - 0093

Kishiwada, Osaka, 596-0042, Japan

Location

Local Institution - 0103

Takatsuki-Shi, Osaka, 569-1045, Japan

Location

Local Institution - 0013

Lódz, Lódzkie, 92-213, Poland

Location

Local Institution - 0031

Bialystok, Podlaskie Voivodeship, 15-276, Poland

Location

Local Institution - 0086

Pusan, Busan Gwangyeogsi, 49241, South Korea

Location

Local Institution - 0084

Daejeon, Daejeon Gwang'yeogsi, 35015, South Korea

Location

Local Institution - 0083

Gwangju, Gwangju Gwang'yeogsi, 61469, South Korea

Location

Local Institution - 0098

Seongnam, Gyeonggido, 13620, South Korea

Location

Local Institution - 0056

Junggu, Incheon Gwang'yeogsi, 22332, South Korea

Location

Local Institution - 0081

Seoul, Seoul Teugbyeolsi, 03080, South Korea

Location

Local Institution - 0085

Seoul, Seoul Teugbyeolsi, 03722, South Korea

Location

Local Institution - 0114

Seoul, Seoul Teugbyeolsi, 06351, South Korea

Location

Local Institution - 0055

Seoul, Seoul Teugbyeolsi, 06591, South Korea

Location

Local Institution - 0088

Daegu, 42601, South Korea

Location

Local Institution - 0012

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

Location

Local Institution - 0025

Majadahonda, Madrid, 28222, Spain

Location

Local Institution - 0021

El Palmar, Murcia, 30120, Spain

Location

Local Institution - 0026

Madrid, 28034, Spain

Location

Local Institution - 0032

Málaga, 29010, Spain

Location

Local Institution - 0018

Seville, 41014, Spain

Location

Local Institution - 0010

Valencia, 46010, Spain

Location

Local Institution - 0063

Harrow, Greater London, HA1 3UJ, United Kingdom

Location

Local Institution - 0071

North Shields, Northumberland, NE29 8NH, United Kingdom

Location

Local Institution - 0072

Leeds, Yorkshire, LS1 3EX, United Kingdom

Location

Local Institution - 0101

Bristol, BS2 8HW, United Kingdom

Location

Local Institution - 0097

Dundee, DD1 9SY, United Kingdom

Location

Local Institution - 0075

London, SE1 7EH, United Kingdom

Location

Local Institution - 0062

Oxford, OX3 9DU, United Kingdom

Location

Local Institution - 0065

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

Location

Local Institution - 0064

Wolverhampton, WV10 0QP, United Kingdom

Location

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

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): December 14, 2026
• Study Completion (Estimated): December 14, 2026
• Last Updated: July 30, 2026

Record last verified: 2026-07

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); AR (11); ES (7); KR (10); CA (2); IT (4); GB (9); US (23); JP (5); PL (2); CN (5)