Active — Not RecruitingPhase 3

A Study to Evaluate Mavacamten in Adolescents With Symptomatic Obstructive Hypertrophic Cardiomyopathy

United States44 participantsStarted 2024-04-17

Plain-language summary

The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics of mavacamten in adolescent patients with symptomatic obstructive hypertrophic cardiomyopathy (HCM).

Who can participate

Age range12 Years – 17 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Diagnosis of HCM * Presence of LVOT obstruction * Presence of symptoms Exclusion Criteria: * Phenocopy diseases resulting in myocardial hypertrophy not related to sarcomere dysfunction * Evidence of LVEF \<50% in prior 6 months * Planned escalation in HCM therapy or upcoming intervention (eg, major cardiac surgery, HCM medication dose increase) Other protocol-defined Inclusion/Exclusion criteria apply.

What they're measuring

Change from baseline in Valsalva left ventricular outflow tract (LVOT) (VLVOT) gradient

Timeframe: At Week 28

Trial details

NCT IDNCT06253221

SponsorBristol-Myers Squibb

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-11-25

View on ClinicalTrials.gov More Cardiomyopathy, Hypertrophic trials