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

ConditionHeart Failure
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age40-85
SponsorBristol-Myers Squibb

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

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

Design model

Sequential

Treatments tested in this trial

  • BMS-986435

    Drug

    Specified dose on specified days

  • Placebo

    Other intervention

    Specified dose on specified days

Treatment groups

208 Participants
are divided into 2 treatment groups
Group A: BMS-986435Experimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Bristol-Myers Squibb

Lead sponsor

Source ClinicalTrials.gov
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