Active — Not RecruitingNot Applicable

A Study to Assess the Treatment of Obstructive Hypertrophic Cardiomyopathy (oHCM) With Mavacamten in the US

United States150 participantsStarted 2023-12-22

Plain-language summary

The purpose of this study is to evaluate the real-world safety and effectiveness of patients with symptomatic obstructive hypertrophic cardiomyopathy (oHCM) initiated on mavacamten at certain high volume HCM centers in the US

Who can participate

Age range18 Years

SexALL

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Inclusion Criteria: * Age ≥ 18 years at the index date * Prescription of mavacamten for the treatment of Obstructive hypertrophic cardiomyopathy (oHCM) with NYHA Class II or III * ≥ 12 weeks of follow-up after prescription of mavacamten, except for the baseline data reporting Exclusion Criteria: * Data collection as part of a clinical trial during the study period * Participation in a myosin inhibitor clinical trial

What they're measuring

New York Heart Association (NYHA) functional class

Timeframe: Baseline, and at weeks 4, 8, 12, 24, 36, 48, 60, 72, and in increments of 12 weeks thereafter from index

Left ventricular outflow tract (LVOT) gradient and associated parameters

Timeframe: Baseline, and at weeks 4, 8, 12, 24, 36, 48, 60, 72, and in increments of 12 weeks thereafter from index

Left ventricular ejection fraction (LVEF) and associated parameters

Timeframe: Baseline, and at weeks 4, 8, 12, 24, 36, 48, 60, 72, and in increments of 12 weeks thereafter from index

Trial details

NCT IDNCT07107373

SponsorBristol-Myers Squibb

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2024-07-26

View on ClinicalTrials.gov More Obstructive Hypertrophic Cardiomyopathy (oHCM) trials