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NCT Number: NCT06551129

Real-world Patient Reported Outcomes Among Patients Treated With Camzyos

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.

Recruiting

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Key information

Conditions

Obstructive Hypertrophic Cardiomyopathy 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

Analysis Group Inc.

Boston, Massachusetts, 02199, United States

Location status: Recruiting

Location contact

Min Yang, Site 0001

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

Mavacamten

Drug

As prescribed by treating physician

Primary outcomes

  1. Participant Hypertrophic Cardiomyopathy symptoms as assessed by Hypertrophic Cardiomyopathy Symptom Questionnaire (HCMSQ v2,0 - 7-day recall version)

    Time frame: Baseline and weeks 2, 4, 8, 12, 24, 30, 48, 60, 72, 84 and 96

  2. Participant physical limitation, symptom stability, symptom frequency, symptom burden, self-efficacy, QoL, and social limitations as assessed by Kansas City Cardiomyopathy Questionnaire (KCCQ-23)

    Time frame: Baseline and weeks 2, 4, 8, 12, 24, 30, 48, 60, 72, 84 and 96

  3. Participant mavacamten treatment status

    Time frame: Weeks 2, 4, 8, 12, 24, 30, 48, 60, 72, 84 and 96

  4. Other pharmacological and surgical treatments for obstructive hypertrophic cardiomyopathy (HCM)

    Time frame: Baseline and weeks 2, 4, 8, 12, 24, 30, 48, 60, 72, 84 and 96

  5. Participant symptom severity as assessed by self-assessed New York Heart Association (SA-NYHA) functional class

    Time frame: Baseline and weeks 2, 4, 8, 12, 24, 30, 48, 60, 72, 84 and 96

  6. Participant change in symptom severity as assessed by Patient Global Impression of Change (PGI-C)

    Time frame: Weeks 2, 4, 8, 12, 24, 30, 48, 72, and 96

  7. Participant septal reduction therapy

    Time frame: Baseline and weeks 12, 30, 48 and 96

  8. Participant major injury or surgery since previous survey

    Time frame: Weeks 2, 4, 8, 12, 24, 30, 48, 60, 72, 84 and 96

  9. Participant survey response on experience with CAMZYOS Risk Evaluation and Mitigation Strategy program (REMS) Program

    Time frame: Baseline and weeks 4, 12, 30, 48, 72 and 96

  10. Participant medical history

    Time frame: Baseline

Study contacts

Contact information is provided by the study sponsor or research team.

BMS Study Connect Contact Center www.BMSStudyConnect.com

CONTACT

[email protected]

855-907-3286

First line of the email MUST contain NCT # and Site #.

CONTACT

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

Real-World Camzyos Patient Reported OutcoMes Through PAtient SurveyS in Hypertrophic CardioMyopathy (COMPASS-HCM): A Prospective Longitudinal Study

Acronym: COMPASS-HCM

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Aug 13, 2024
Registry last updated
Nov 7, 2024

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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