Mavacamten in Obstructive Hypertrophic Cardiomyopathy

NCT07168655 | Completed FDA Drug

• 1 other identifier: CV027-1039
• Study Type: observational
• Target: 163
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Obstructive Hypertrophic Cardiomyopathy (oHCM)

Keywords

Obstructive Hypertrophic cardiomyopathy (oHCM)

Outcome Measures

Primary Outcomes (20)

• Participant New York Heart Association (NYHA) functional class

  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)

  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

  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

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

• Participant age

  Baseline

• Participant gender

  Baseline

• Participant race

  Baseline

• Participant ethnicity

  Baseline

• Participant insurance coverage

  Baseline

• Participant Body Mass Index

  Baseline

• Participant blood pressure

  Baseline

• Participant heart rate

  Baseline

• Participant genotype

  Baseline

• Participant family history

  Baseline

• Participant New York Functional Class classification

  Baseline

• Participant echocardiogram measurements

  Baseline

• Participant comorbidities

  Baseline

• Participant hypertrophic cardiomyopathy (HCM) treatment history

  Baseline

• Mavacamten index dose prescribed

  Baseline

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

  Baseline

Study Arms (1)

Participants prescribed mavacamten treatment

Drug: Mavacamten

Interventions

Mavacamten DRUG

According to the product label

Participants prescribed mavacamten treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Links

• BMS Clinical Trial Information
• FDA Safety Alerts and Recalls

MeSH Terms

Conditions

Cardiomyopathy, Hypertrophic

Interventions

MYK-461

Condition Hierarchy (Ancestors)

Cardiomyopathies; Heart Diseases; Cardiovascular Diseases; Aortic Stenosis, Subvalvular; Aortic Valve Stenosis; Aortic Valve Disease; Heart Valve Diseases

Study Officials

• Bristol Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2025
• First Posted: September 11, 2025
• Study Start: February 21, 2023
• Primary Completion: March 31, 2023
• Study Completion: March 25, 2025
• Last Updated: September 11, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)