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NCT Number: NCT06122779

Study to Evaluate Safety, Tolerability and Drug Levels 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).

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

40 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Local Institution - 0054, Ciudad del Libertador General San Martin, Buenos Aires, Argentina

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

BMS-986435

Drug

Specified dose on specified days

Other names: MYK-224

Placebo

Other

Specified dose on specified days

Primary outcomes

  1. Incidence of treatment emergent adverse events (TEAEs)

    Time frame: Up to approximately 24 weeks

  2. Incidence of serious adverse events (SAEs)

    Time frame: Up to approximately 24 weeks

  3. Incidence of AEs leading to treatment discontinuation

    Time frame: Up to approximately 20 weeks

Secondary outcomes

  1. Summary of plasma concentrations of MYK-224

    Time frame: Up to approximately 20 weeks

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study 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)

Acronym: AURORA-HFpEF

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Nov 8, 2023
Registry last updated
Jul 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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