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

July 29, 2026 updated by: Bristol-Myers Squibb

A Phase 2A, Double-blind, Randomized, Placebo-controlled, Multi-center Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BMS-986435/MYK-224 in Participants With Heart Failure With Preserved Ejection Fraction (HFpEF)

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).

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

227

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, 1407
        • Local Institution - 0060
      • Buenos Aires, Argentina, C1431FWO
        • Local Institution - 0067
      • Córdoba, Argentina, X5000AOQ
        • Local Institution - 0074
      • Salta, Argentina, A4406BPF
        • Local Institution - 0069
      • Santa Fe, Argentina, S3000FWO
        • Local Institution - 0102
    • Buenos Aires
      • Ciudad del Libertador General San Martin, Buenos Aires, Argentina, B1650BNB
        • Local Institution - 0054
      • Zárate, Buenos Aires, Argentina, B2800DGH
        • Local Institution - 0115
    • Córdoba Province
      • Córdoba, Córdoba Province, Argentina, 5000
        • Local Institution - 0090
      • Córdoba, Córdoba Province, Argentina, X5003DCE
        • Local Institution - 0053
    • Santa Fe Province
      • Rosario, Santa Fe Province, Argentina, 2000
        • Local Institution - 0073
    • Tucumán Province
      • San Miguel de Tucumán, Tucumán Province, Argentina, T4000IAP
        • Local Institution - 0061
  • Canada
    • Ontario
      • Hamilton, Ontario, Canada, L8L 2X2
        • Local Institution - 0007
      • Toronto, Ontario, Canada, M4P 1E4
        • Local Institution - 0037
  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100730
        • Local Institution - 0089
    • Guangdong
      • Guangzhou, Guangdong, China, 510120
        • Local Institution - 0087
    • Henan
      • Luoyang, Henan, China, 471003
        • Local Institution - 0080
    • Hunan
      • Changsha, Hunan, China, 410011
        • Local Institution - 0079
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310009
        • Local Institution - 0082
  • Israel
      • Beersheba, Israel, 84101
        • Local Institution - 0111
      • Be’er Ya‘aqov, Israel, 7033001
        • Local Institution - 0112
      • Haifa, Israel, 3109601
        • Local Institution - 0108
      • Jerusalem, Israel, 9103102
        • Local Institution - 0113
      • Petah Tikva, Israel, 49100
        • Local Institution - 0110
      • Rehovot, Israel, 76100
        • Local Institution - 0106
      • Safed, Israel, 1311001
        • Local Institution - 0116
    • Jerusalem
      • Jerusalem, Jerusalem, Israel, 90000
        • Local Institution - 0109
  • Italy
      • Bergamo, Italy, 24127
        • Local Institution - 0009
    • Campania
      • Naples, Campania, Italy, 80131
        • Local Institution - 0019
    • Lombardy
      • San Donato Milanese, Lombardy, Italy, 20097
        • Local Institution - 0022
    • Tuscany
      • Pisa, Tuscany, Italy, 56126
        • Local Institution - 0017
  • Japan
    • Hyōgo
      • Himeji-Shi, Hyōgo, Japan, 672-8044
        • Local Institution - 0092
    • Ishikawa-ken
      • Kanazawa, Ishikawa-ken, Japan, 920-8650
        • Local Institution - 0100
    • Okayama-ken
      • Okayama, Okayama-ken, Japan, 702-8055
        • Local Institution - 0091
    • Osaka
      • Kishiwada, Osaka, Japan, 596-0042
        • Local Institution - 0093
      • Takatsuki-Shi, Osaka, Japan, 569-1045
        • Local Institution - 0103
  • Poland
    • Lódzkie
      • Lódz, Lódzkie, Poland, 92-213
        • Local Institution - 0013
    • Podlaskie Voivodeship
      • Bialystok, Podlaskie Voivodeship, Poland, 15-276
        • Local Institution - 0031
  • South Korea
      • Daegu, South Korea, 42601
        • Local Institution - 0088
    • Busan Gwangyeogsi
      • Pusan, Busan Gwangyeogsi, South Korea, 49241
        • Local Institution - 0086
    • Daejeon Gwang'yeogsi
      • Daejeon, Daejeon Gwang'yeogsi, South Korea, 35015
        • Local Institution - 0084
    • Gwangju Gwang'yeogsi
      • Gwangju, Gwangju Gwang'yeogsi, South Korea, 61469
        • Local Institution - 0083
    • Gyeonggido
      • Seongnam, Gyeonggido, South Korea, 13620
        • Local Institution - 0098
    • Incheon Gwang'yeogsi
      • Junggu, Incheon Gwang'yeogsi, South Korea, 22332
        • Local Institution - 0056
    • Seoul Teugbyeolsi
      • Seoul, Seoul Teugbyeolsi, South Korea, 03080
        • Local Institution - 0081
      • Seoul, Seoul Teugbyeolsi, South Korea, 03722
        • Local Institution - 0085
      • Seoul, Seoul Teugbyeolsi, South Korea, 06351
        • Local Institution - 0114
      • Seoul, Seoul Teugbyeolsi, South Korea, 06591
        • Local Institution - 0055
  • Spain
      • Madrid, Spain, 28034
        • Local Institution - 0026
      • Málaga, Spain, 29010
        • Local Institution - 0032
      • Seville, Spain, 41014
        • Local Institution - 0018
      • Valencia, Spain, 46010
        • Local Institution - 0010
    • Barcelona
      • L'Hospitalet de Llobregat, Barcelona, Spain, 08907
        • Local Institution - 0012
    • Madrid
      • Majadahonda, Madrid, Spain, 28222
        • Local Institution - 0025
    • Murcia
      • El Palmar, Murcia, Spain, 30120
        • Local Institution - 0021
  • United Kingdom
      • Bristol, United Kingdom, BS2 8HW
        • Local Institution - 0101
      • Dundee, United Kingdom, DD1 9SY
        • Local Institution - 0097
      • London, United Kingdom, SE1 7EH
        • Local Institution - 0075
      • Oxford, United Kingdom, OX3 9DU
        • Local Institution - 0062
      • Stockton-on-Tees, United Kingdom, TS19 8PE
        • Local Institution - 0065
      • Wolverhampton, United Kingdom, WV10 0QP
        • Local Institution - 0064
    • Greater London
      • Harrow, Greater London, United Kingdom, HA1 3UJ
        • Local Institution - 0063
    • Northumberland
      • North Shields, Northumberland, United Kingdom, NE29 8NH
        • Local Institution - 0071
    • Yorkshire
      • Leeds, Yorkshire, United Kingdom, LS1 3EX
        • Local Institution - 0072
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • Local Institution - 0002
    • Colorado
      • Lakewood, Colorado, United States, 80228-1710
        • Local Institution - 0096
    • Florida
      • Jacksonville, Florida, United States, 32204-4748
        • Local Institution - 0077
      • Miami, Florida, United States, 33133-4223
        • Local Institution - 0003
      • Miami, Florida, United States, 33136-2107
        • Local Institution - 0099
    • Illinois
      • Chicago, Illinois, United States, 60611-5969
        • Local Institution - 0004
      • Hazel Crest, Illinois, United States, 60429-2196
        • Local Institution - 0005
    • Indiana
      • Indianapolis, Indiana, United States, 46260-1992
        • Local Institution - 0029
    • Missouri
      • St Louis, Missouri, United States, 63136-6111
        • Local Institution - 0028
    • New Jersey
      • Hackensack, New Jersey, United States, 07601-1915
        • Local Institution - 0117
    • New York
      • Albany, New York, United States, 12211
        • Local Institution - 0070
      • Brooklyn, New York, United States, 11215
        • Local Institution - 0105
      • New York, New York, United States, 10065-4805
        • Local Institution - 0008
      • Rochester, New York, United States, 14618-2668
        • Local Institution - 0059
      • Rochester, New York, United States, 14621
        • Local Institution - 0076
      • Rosedale, New York, United States, 11422-1320
        • Local Institution - 0094
    • North Carolina
      • Durham, North Carolina, United States, 27710-4000
        • Local Institution - 0095
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73135-2607
        • Local Institution - 0016
    • Pennsylvania
      • Abington, Pennsylvania, United States, 19001
        • Local Institution - 0078
    • Tennessee
      • Tullahoma, Tennessee, United States, 37388-8260
        • Local Institution - 0001
    • Texas
      • Austin, Texas, United States, 78756-4080
        • Local Institution - 0104
      • Dallas, Texas, United States, 75390
        • Local Institution - 0036
      • Houston, Texas, United States, 77025-5253
        • Local Institution - 0015

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.
  • Other protocol-defined Inclusion/Exclusion criteria apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Other: Placebo
Specified dose on specified days
Experimental: BMS-986435
Drug: BMS-986435
Specified dose on specified days
Other Names:
  • MYK-224

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of treatment emergent adverse events (TEAEs)
Time Frame: Up to approximately 24 weeks
Up to approximately 24 weeks
Incidence of serious adverse events (SAEs)
Time Frame: Up to approximately 24 weeks
Up to approximately 24 weeks
Incidence of AEs leading to treatment discontinuation
Time Frame: Up to approximately 20 weeks
Up to approximately 20 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Summary of plasma concentrations of MYK-224
Time Frame: Up to approximately 20 weeks
Up to approximately 20 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Investigators

  • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 7, 2023

Primary Completion (Estimated)

December 14, 2026

Study Completion (Estimated)

December 14, 2026

Study Registration Dates

First Submitted

November 3, 2023

First Submitted That Met QC Criteria

November 3, 2023

First Posted (Actual)

November 8, 2023

Study Record Updates

Last Update Posted (Actual)

July 30, 2026

Last Update Submitted That Met QC Criteria

July 29, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CV029-1001
  • 2023-505919-21 (EudraCT Number)
  • U1111-1292-8451 (Other Identifier: WHO)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html

IPD Sharing Time Frame

See Plan Description

IPD Sharing Access Criteria

See Plan Description

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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