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OpenTrials
Active, Not Recruiting

NCT Number: NCT07107373

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

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Obstructive Hypertrophic Cardiomyopathy (oHCM) Aortic Stenosis, Subvalvular Aortic Valve Disease Aortic Valve Stenosis Cardiomyopathies Cardiomyopathy, Hypertrophic Cardiovascular Diseases Heart Diseases Heart Valve Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of California, San Francisco (UCSF)

San Francisco, California, 94118, United States

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Mavacamten

Drug

According to the product label

Primary outcomes

  1. New York Heart Association (NYHA) functional class

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

  2. Left ventricular outflow tract (LVOT) gradient and associated parameters

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

  3. Left ventricular ejection fraction (LVEF) and associated parameters

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

Secondary outcomes

  1. Mavacamten dose at initiation

    Time frame: Day 1

  2. Mavacamten dose change

    Time frame: Up to 72 weeks

  3. Reason for mavacamten dose change

    Time frame: Up to 72 weeks

  4. Reason for mavacamten permanent discontinuation

    Time frame: Up to 72 weeks

  5. Reason for treatment interruption

    Time frame: Up to 72 weeks

  6. Prior Obstructive hypertrophic cardiomyopathy (oHCM) therapies

    Time frame: Baseline

  7. Concurrent Obstructive hypertrophic cardiomyopathy (oHCM) therapies

    Time frame: Up to 72 weeks

  8. Other cardiovascular-related treatments prescribed

    Time frame: Up to 72 weeks

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

MavAcamten Real World eVidEnce coLlaboration in HCM (MARVEL-HCM)

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Aug 6, 2025
Registry last updated
Aug 6, 2025

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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