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)

April 15, 2024 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

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

48

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 Contact

  • Name: BMS Study Connect Contact Center www.BMSStudyConnect.com
  • Phone Number: 855-907-3286
  • Email: Clinical.Trials@bms.com

Study Contact Backup

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

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M4P 1E4
        • Recruiting
        • Medicus MFC Inc.
        • Contact:
          • Gordon Moe, Site 0037
          • Phone Number: 4168645319
      • Toronto, Ontario, Canada, M5S 1B2
        • Not yet recruiting
        • Local Institution - 0030
        • Contact:
          • Site 0030
      • Toronto, Ontario, Canada, M5S 1B2
        • Withdrawn
        • Local Institution - 0040
    • Quebec
      • Trois-Rivieres, Quebec, Canada, G9A 1Y1
        • Not yet recruiting
        • Local Institution - 0035
        • Contact:
          • Site 0035
  • Italy
      • Bergamo, Italy, 24127
        • Not yet recruiting
        • Local Institution - 0009
        • Contact:
          • Site 0009
    • Campania
      • Napoli, Campania, Italy, 80131
        • Not yet recruiting
        • Local Institution - 0019
        • Contact:
          • Site 0019
    • Lombardia
      • Melegnano, Lombardia, Italy, 20077
        • Not yet recruiting
        • Local Institution - 0022
        • Contact:
          • Site 0022
      • Milano, Lombardia, Italy, 20162
        • Not yet recruiting
        • Local Institution - 0023
        • Contact:
          • Site 0023
      • Milano, Lombardia, Italy, 20162
        • Withdrawn
        • Local Institution - 0033
      • San Donato Milanese, Lombardia, Italy, 20097
        • Withdrawn
        • Local Institution - 0050
    • Puglia
      • Foggia, Puglia, Italy, 71100
        • Not yet recruiting
        • Local Institution - 0038
        • Contact:
          • Site 0038
      • Foggia, Puglia, Italy, 71100
        • Withdrawn
        • Local Institution - 0027
    • Toscana
      • Massa, Toscana, Italy, 54100
        • Withdrawn
        • Local Institution - 0052
      • Pisa, Toscana, Italy, 56124
        • Not yet recruiting
        • Local Institution - 0017
        • Contact:
          • Site 0017
  • Poland
      • Krakow, Poland, 30-082
        • Withdrawn
        • Local Institution - 0006
      • Lublin, Poland, 20-954
        • Withdrawn
        • Local Institution - 0049
      • Oswiecim, Poland, 51162
        • Withdrawn
        • Local Institution - 0024
    • Lubelskie
      • Lublin, Lubelskie, Poland, 20-954
        • Not yet recruiting
        • Local Institution - 0020
        • Contact:
          • Site 0020
    • Lódzkie
      • Lódz, Lódzkie, Poland, 92-213
        • Not yet recruiting
        • Local Institution - 0013
        • Contact:
          • Site 0013
    • Podlaskie
      • Bialystok, Podlaskie, Poland, 15-276
        • Not yet recruiting
        • Local Institution - 0031
        • Contact:
          • Site 0031
      • Bialystok, Podlaskie, Poland, 15-276
        • Withdrawn
        • Local Institution - 0044
  • Spain
      • Madrid, Spain, 28034
        • Not yet recruiting
        • Local Institution - 0026
        • Contact:
          • Site 0026
      • Madrid, Spain, 28034
        • Withdrawn
        • Local Institution - 0034
      • Murcia, Spain, 30120
        • Not yet recruiting
        • Local Institution - 0021
        • Contact:
          • Site 0021
      • Sevilla, Spain, 41014
        • Not yet recruiting
        • Local Institution - 0018
        • Contact:
          • Site 0018
      • Sevilla, Spain, 41014
        • Withdrawn
        • Local Institution - 0046
    • Madrid
      • Majadahonda, Madrid, Spain, 28222
        • Not yet recruiting
        • Local Institution - 0025
        • Contact:
          • Site 0025
      • Majadahonda, Madrid, Spain, 28222
        • Withdrawn
        • Local Institution - 0047
    • Murcia
      • El Palmar, Murcia, Spain, 30120
        • Withdrawn
        • Local Institution - 0039
    • Málaga
      • Malaga, Málaga, Spain, 29010
        • Withdrawn
        • Local Institution - 0042
    • Ourense
      • a Gudina, Ourense, Spain, 32540
        • Not yet recruiting
        • Local Institution - 0032
        • Contact:
          • Site 0032
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • Recruiting
        • University of Alabama at Birmingham
        • Contact:
          • Pankaj Arora, Site 0002
    • Florida
      • Miami, Florida, United States, 33133-4223
        • Recruiting
        • Infinite Clinical Research
        • Contact:
          • Sander Fernandez, Site 0003
    • Georgia
      • Atlanta, Georgia, United States, 30322-1013
        • Not yet recruiting
        • Emory Heart and Vascular Center
        • Contact:
          • Alanna Morris, Site 0014
      • Atlanta, Georgia, United States, 30322-1013
        • Withdrawn
        • Local Institution - 0048
    • Illinois
      • Hazel Crest, Illinois, United States, 60429-2196
        • Recruiting
        • Chicago Medical Research, LLC
        • Contact:
          • Suhail Khadra, Site 0005
          • Phone Number: 708-798-8522
    • Indiana
      • Indianapolis, Indiana, United States, 46260-1992
        • Withdrawn
        • Local Institution - 0045
      • Indianapolis, Indiana, United States, 46260-1992
        • Not yet recruiting
        • Local Institution - 0029
        • Contact:
          • Site 0029
    • Missouri
      • Saint Louis, Missouri, United States, 63136
        • Withdrawn
        • Local Institution - 0043
      • Saint Louis, Missouri, United States, 63136-6111
        • Recruiting
        • St. Louis Heart and Vascular
        • Contact:
          • Harvey Serota, Site 0028
          • Phone Number: 314-741-0911
    • New York
      • New York, New York, United States, 10065-4805
        • Recruiting
        • Weill Cornell Medicine
        • Contact:
          • Parag Goyal, Site 0008
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73135
        • Not yet recruiting
        • South Oklahoma Heart Research
        • Contact:
          • Naeem Tahirkheli, Site 0016
          • Phone Number: 405-628-6865
      • Oklahoma City, Oklahoma, United States, 73135-2607
        • Withdrawn
        • Local Institution - 0041
    • Tennessee
      • Tullahoma, Tennessee, United States, 37388-8260
        • Recruiting
        • Tennessee Center For Clinical Trials
        • Contact:
          • Dinesh Gupta, Site 0001
          • Phone Number: 931-461-2663
    • Texas
      • Dallas, Texas, United States, 75390
        • Recruiting
        • University of Texas Southwestern Medical Center
        • Contact:
          • Ambarish Pandey, Site 0036
          • Phone Number: 214-645-8000
      • Houston, Texas, United States, 77025-5253
        • Withdrawn
        • Local Institution - 0051
      • Houston, Texas, United States, 77025-5253
        • Recruiting
        • Angiocardiac Care of Texas - PA - PPDS
        • Contact:
          • Amin Karim, Site 0015
          • Phone Number: 281-944-3610

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 15 weeks
Up to approximately 15 weeks
Incidence of serious adverse events (SAEs)
Time Frame: Up to approximately 15 weeks
Up to approximately 15 weeks
Incidence of AEs leading to treatment discontinuation
Time Frame: Up to approximately 10 weeks
Up to approximately 10 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Summary of plasma concentrations of MYK-224
Time Frame: Up to approximately 15 weeks
Up to approximately 15 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)

January 22, 2025

Study Completion (Estimated)

January 22, 2025

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)

April 17, 2024

Last Update Submitted That Met QC Criteria

April 15, 2024

Last Verified

April 1, 2024

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/disclosurecommitment.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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