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Recruiting NCT06551129

Real-world Patient Reported Outcomes Among Patients Treated With Camzyos

— Observational Obstructive Hypertrophic Cardiomyopathy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Mavacamten.
Who it may be relevant to
Registry conditions: Obstructive Hypertrophic Cardiomyopathy. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Drug Mavacamten
    As prescribed by treating physician

Primary outcome measures

  • 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]
  • 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]
  • Participant mavacamten treatment status [Time frame: Weeks 2, 4, 8, 12, 24, 30, 48, 60, 72, 84 and 96]
  • 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]
  • 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]
  • 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]
  • Participant septal reduction therapy [Time frame: Baseline and weeks 12, 30, 48 and 96]
  • Participant major injury or surgery since previous survey [Time frame: Weeks 2, 4, 8, 12, 24, 30, 48, 60, 72, 84 and 96]
  • 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]
  • Participant medical history [Time frame: Baseline]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • Analysis Group Inc. — Boston

Identifiers

NCT: NCT06551129 · CV027-1002

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗