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)

Bristol-Myers Squibb (BMS)

Status and phase: Enrolling; Phase 2

Conditions: Heart Failure

Treatments: Other: Placebo; Drug: BMS-986435

Study type: Interventional

Funder types: Industry

Identifiers

NCT06122779

CV029-1001

2023-505919-21 (EudraCT Number)

U1111-1292-8451 (Other Identifier)

Details and patient eligibility

About

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).

Enrollment: 208 estimated patients

Sex: All

Ages: 40 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Quadruple Blind

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208 participants in 2 patient groups, including a placebo group

BMS-986435

Experimental group

Treatment:

Drug: BMS-986435

Placebo

Placebo Comparator group

Treatment:

Other: Placebo