Status:

RECRUITING

Real-world Patient Reported Outcomes Among Patients Treated With Camzyos

Lead Sponsor:

Bristol-Myers Squibb

Conditions:

Obstructive Hypertrophic Cardiomyopathy

Eligibility:

All Genders

18+ years

Brief Summary

This real-world study will assess changes in health status among participants with symptomatic obstructive hypertrophic cardiomyopathy who are treated with mavacamten in the real world.

Eligibility Criteria

Inclusion

  • Participants ≥18 years of age.
  • Participants who are prescribed mavacamten for obstructive hypertrophic cardiomyopathy
  • Provided informed consent to participate in the study

Exclusion

  • Previously or currently enrolled in clinical trials for any cardiac myosin inhibitors
  • Treated for \>7 days with mavacamten by the day of completing the baseline survey
  • Enrolled in any clinical trials at the time of or within the six-month period prior to the screening
  • Had heart attack requiring coronary artery bypass grafting within the three-month period prior to the screening
  • Had stroke or transient ischemic attack within the six-month period prior to the screening
  • Had moderate-to-severe lung disease which impacted the ability to perform daily activities of living and ability to breathe
  • Had major lung (thoracic) or heart (cardiac) surgery within the six-month period prior to the screening
  • Scheduled for a major surgery for the next three months, such as joint surgeries including hip replacement, abdominal surgeries, lung surgeries, heart surgeries, eye surgeries, brain surgeries, and any other major surgeries that require general anesthesia and at least an overnight hospital stay
  • Hospitalized requiring an overnight stay at the time of or within the two-week period prior to the screening

Key Trial Info

Start Date :

May 10 2024

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

June 30 2027

Estimated Enrollment :

118 Patients enrolled

Trial Details

Trial ID

NCT06551129

Start Date

May 10 2024

End Date

June 30 2027

Last Update

November 7 2024

Active Locations (1)

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1

Analysis Group Inc.

Boston, Massachusetts, United States, 02199