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OpenTrials
Completed

NCT Number: NCT07168655

Mavacamten in Obstructive Hypertrophic Cardiomyopathy

The purpose of this study is to evaluate the real-world outcomes of individuals diagnosed with obstructive hypertrophic cardiomyopathy (oHCM) treated with mavacamten at the Hospital of The University of Pennsylvania in the US

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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 Pennsylvania

Philadelphia, Pennsylvania, 19104, 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 index date
  • Prescription of mavacamten for the treatment of Obstructive Hypertrophic Cardiomyopathy (oHCM)
  • ≥ 4 weeks of follow-up after prescription of mavacamten

Exclusion criteria

  • Data collection as part of a clinical trial during the study period
  • Current participation in a myosin inhibitor clinical trial

Treatment and study plan

Mavacamten

Drug

According to the product label

Primary outcomes

  1. Participant New York Heart Association (NYHA) functional class

    Time frame: Baseline, and at weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, and 108 weeks

  2. Participant echocardiogram measurements: Left ventricular outflow tract (LVOT) gradient results at rest, Valsalva and post-exercise (if available)

    Time frame: Baseline, and at weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, and 108 weeks

  3. Participant echocardiogram measurements: Left ventricular ejection fraction (LVEF) percentage

    Time frame: Baseline, and at weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, and 108 weeks

  4. Participant echocardiogram measurements: Maximum left ventricular wall thickness

    Time frame: Baseline, and at weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, and 108 weeks

  5. Participant age

    Time frame: Baseline

  6. Participant gender

    Time frame: Baseline

  7. Participant race

    Time frame: Baseline

  8. Participant ethnicity

    Time frame: Baseline

  9. Participant insurance coverage

    Time frame: Baseline

  10. Participant Body Mass Index

    Time frame: Baseline

  11. Participant blood pressure

    Time frame: Baseline

  12. Participant heart rate

    Time frame: Baseline

  13. Participant genotype

    Time frame: Baseline

  14. Participant family history

    Time frame: Baseline

  15. Participant New York Functional Class classification

    Time frame: Baseline

  16. Participant echocardiogram measurements

    Time frame: Baseline

  17. Participant comorbidities

    Time frame: Baseline

  18. Participant hypertrophic cardiomyopathy (HCM) treatment history

    Time frame: Baseline

  19. Mavacamten index dose prescribed

    Time frame: Baseline

  20. Participant obstructive hypertrophic cardiomyopathy (oHCM) symptoms (syncope, shortness of breath, fatigue, exercise intolerance, palpitations)

    Time frame: Baseline

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

Real-World Patients With Obstructive Hypertrophic Cardiomyopathy Treated With Mavacamten - a Single-Center Descriptive Study

Important dates

Study start
2023
Primary completion
2023
Study completion
2025
First posted
Sep 11, 2025
Registry last updated
Sep 11, 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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