Mavacamten in Obstructive Hypertrophic Cardiomyopathy

September 4, 2025 updated by: Bristol-Myers Squibb

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

163

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The study population will comprise of adult individuals diagnosed with Obstructive Hypertrophic cardiomyopathy (oHCM) that have been prescribed mavacamten at The Hospital of the University of Pennsylvania between April 1, 2022 and January 17, 2025

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Participants prescribed mavacamten treatment
Drug: Mavacamten
According to the product label

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Participant age
Time Frame: Baseline
Baseline
Participant comorbidities
Time Frame: Baseline
Baseline
Participant race
Time Frame: Baseline
Baseline
Participant ethnicity
Time Frame: Baseline
Baseline
Participant insurance coverage
Time Frame: Baseline
Baseline
Participant blood pressure
Time Frame: Baseline
Baseline
Participant heart rate
Time Frame: Baseline
Baseline
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
Baseline, and at weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, and 108 weeks
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
Baseline, and at weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, and 108 weeks
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
Baseline, and at weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, and 108 weeks
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
Baseline, and at weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, and 108 weeks
Participant gender
Time Frame: Baseline
Baseline
Participant Body Mass Index
Time Frame: Baseline
Baseline
Participant genotype
Time Frame: Baseline
Baseline
Participant family history
Time Frame: Baseline
Baseline
Participant New York Functional Class classification
Time Frame: Baseline
Baseline
Participant echocardiogram measurements
Time Frame: Baseline
Baseline
Participant hypertrophic cardiomyopathy (HCM) treatment history
Time Frame: Baseline
Baseline
Mavacamten index dose prescribed
Time Frame: Baseline
Baseline
Participant obstructive hypertrophic cardiomyopathy (oHCM) symptoms (syncope, shortness of breath, fatigue, exercise intolerance, palpitations)
Time Frame: Baseline
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Investigators

  • Study Director: Bristol Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 21, 2023

Primary Completion (Actual)

March 31, 2023

Study Completion (Actual)

March 25, 2025

Study Registration Dates

First Submitted

July 23, 2025

First Submitted That Met QC Criteria

September 4, 2025

First Posted (Estimated)

September 11, 2025

Study Record Updates

Last Update Posted (Estimated)

September 11, 2025

Last Update Submitted That Met QC Criteria

September 4, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CV027-1039

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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