Real-world Patient Reported Outcomes Among Patients Treated With Camzyos

Last updated: November 6, 2024
Sponsor: Bristol-Myers Squibb
Overall Status: Active - Recruiting

Phase

N/A

Condition

Circulation Disorders

Treatment

Mavacamten

Clinical Study ID

NCT06551129
CV027-1002
  • Ages > 18
  • All Genders

Study 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

Inclusion Criteria:

  • Participants ≥18 years of age.

  • Participants who are prescribed mavacamten for obstructive hypertrophiccardiomyopathy

  • Provided informed consent to participate in the study

Exclusion

Exclusion Criteria:

  • Previously or currently enrolled in clinical trials for any cardiac myosininhibitors

  • 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 priorto the screening

  • Had heart attack requiring coronary artery bypass grafting within the three-monthperiod prior to the screening

  • Had stroke or transient ischemic attack within the six-month period prior to thescreening

  • Had moderate-to-severe lung disease which impacted the ability to perform dailyactivities of living and ability to breathe

  • Had major lung (thoracic) or heart (cardiac) surgery within the six-month periodprior to the screening

  • Scheduled for a major surgery for the next three months, such as joint surgeriesincluding hip replacement, abdominal surgeries, lung surgeries, heart surgeries, eyesurgeries, brain surgeries, and any other major surgeries that require generalanesthesia and at least an overnight hospital stay

  • Hospitalized requiring an overnight stay at the time of or within the two-weekperiod prior to the screening

Study Design

Total Participants: 118
Treatment Group(s): 1
Primary Treatment: Mavacamten
Phase:
Study Start date:
May 10, 2024
Estimated Completion Date:
June 30, 2027

Connect with a study center

  • Analysis Group Inc.

    Boston, Massachusetts 02199
    United States

    Active - Recruiting

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