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

Sponsor
Bristol-Myers Squibb (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT06122779
Collaborator
(none)
48
Enrollment
41
Locations
2
Arms
13.8
Anticipated Duration (Months)
1.2
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
48 participants
Allocation:
Randomized
Intervention Model:
Sequential Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
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)
Anticipated Study Start Date :
Nov 29, 2023
Anticipated Primary Completion Date :
Jan 22, 2025
Anticipated Study Completion Date :
Jan 22, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: BMS-986435

Drug: BMS-986435
Specified dose on specified days
Other Names:
  • MYK-224

    		•
    Placebo Comparator: Placebo

    Other: Placebo
    Specified dose on specified days

    Outcome Measures

    Primary Outcome Measures

    1. Incidence of treatment emergent adverse events (TEAEs) [Up to approximately 15 weeks]

    2. Incidence of serious adverse events (SAEs) [Up to approximately 15 weeks]

    3. Incidence of AEs leading to treatment discontinuation [Up to approximately 10 weeks]

    Secondary Outcome Measures

    1. Summary of plasma concentrations of MYK-224 [Up to approximately 15 weeks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    40 Years to 90 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Key Inclusion Criteria:
    • Adult participants with stable, symptomatic HFpEF with a normal heart pumping ability
    Key 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

    Note: Other protocol-defined inclusion/exclusion criteria apply

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Emory Heart and Vascular Center Atlanta Georgia United States 30322-1013
    2 Emory Heart and Vascular Center Atlanta Georgia United States 30322-1013
    3 Chicago Medical Research, LLC Hazel Crest Illinois United States 60429
    4 St Vincent Hospital and Health Care Centers Inc Indianapolis Indiana United States 46260-1992
    5 St. Vincent Hospital And Health Care Center, Inc. Indianapolis Indiana United States 46260-1992
    6 St. Louis Heart and Vascular Saint Louis Missouri United States 631366150
    7 St. Louis Heart and Vascular Saint Louis Missouri United States 63136
    8 South Oklahoma Heart Research Oklahoma City Oklahoma United States 73135-2607
    9 South Oklahoma Heart Research Oklahoma City Oklahoma United States 73135
    10 Tennessee Center for Clinical Trials Tullahoma Tennessee United States 37388-8260
    11 Clinical Heart and Vascular Center Dallas Texas United States 75390-0001
    12 Angiocardiac Care of Texas - PA - PPDS Houston Texas United States 77025-5253
    13 Angiocardiac Care Of Texas Houston Texas United States 77025-5253
    14 Local Institution - 0037 Toronto Ontario Canada M4P 1E4
    15 Local Institution - 0030 Toronto Ontario Canada M5S 1B2
    16 Local Institution - 0040 Toronto Ontario Canada M5S 1B2
    17 Local Institution - 0035 Trois-Rivieres Quebec Canada G9A 1Y1
    18 Local Institution - 0019 Napoli Campania Italy 80131
    19 Local Institution - 0022 Melegnano Lombardia Italy 20077
    20 Local Institution - 0023 Milano Lombardia Italy 20162
    21 Local Institution - 0033 Milano Lombardia Italy 20162
    22 Local Institution - 0050 San Donato Milanese Lombardia Italy 20097
    23 Local Institution - 0027 Foggia Puglia Italy 71100
    24 Local Institution - 0038 Foggia Puglia Italy 71100
    25 Local Institution - 0052 Massa Toscana Italy 54100
    26 Local Institution - 0017 Pisa Toscana Italy 56124
    27 Local Institution - 0020 Lublin Lubelskie Poland 20-954
    28 Local Institution - 0031 Bialystok Podlaskie Poland 15-276
    29 Local Institution - 0044 Bialystok Podlaskie Poland 15-276
    30 Local Institution - 0049 Lublin Poland 20-954
    31 Local Institution - 0024 Oswiecim Poland 51162
    32 Local Institution - 0025 Majadahonda Madrid Spain 28222
    33 Local Institution - 0047 Majadahonda Madrid Spain 28222
    34 Local Institution - 0039 El Palmar Murcia Spain 30120
    35 Local Institution - 0042 Malaga Málaga Spain 29010
    36 Local Institution - 0032 a Gudina Ourense Spain 32540
    37 Local Institution - 0026 Madrid Spain 28034
    38 Local Institution - 0034 Madrid Spain 28034
    39 Local Institution - 0021 Murcia Spain 30120
    40 Local Institution - 0018 Sevilla Spain 41014
    41 Local Institution - 0046 Sevilla Spain 41014

    Sponsors and Collaborators

    • Bristol-Myers Squibb

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Bristol-Myers Squibb
    ClinicalTrials.gov Identifier:
    NCT06122779
    Other Study ID Numbers:
    • CV029-1001
    • 2023-505919-21
    • U1111-1292-8451
    First Posted:
    Nov 8, 2023
    Last Update Posted:
    Nov 8, 2023
    Last Verified:
    Nov 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Bristol-Myers Squibb
    BMS-986435
    MYK-224
    Pharmacokinetics
    Pharmacodynamics
    Safety
    HFpEF
    Additional relevant MeSH terms:
    Heart Failure

    Study Results

    No Results Posted as of Nov 8, 2023