Actively Recruiting
Real-World Camzyos Patient Reported Outcomes Through Patient Surveys in Hypertrophic Cardiomyopathy (COMPASS-HCM): A Prospective Longitudinal Study
Led by Bristol-Myers Squibb · Updated on 2024-11-07
118
Participants Needed
1
Research Sites
25 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating health changes in adults with symptomatic obstructive hypertrophic cardiomyopathy who are treated with mavacamten in real-world settings. This observational study aims to understand participants' symptoms, physical limitations, quality of life, and treatment experiences over time. The study is sponsored by Bristol-Myers Squibb and collects patient-reported outcomes to monitor the impact of mavacamten treatment. Participants are adults prescribed mavacamten by their doctors for their condition. The study involves completing surveys at multiple time points including baseline, weeks 2, 4, 8, 12, 24, 30, 48, 60, 72, 84, and 96 weeks. These surveys assess symptoms using tools like the Hypertrophic Cardiomyopathy Symptom Questionnaire and the Kansas City Cardiomyopathy Questionnaire, as well as treatment status, other therapies, and health events such as surgeries or injuries. During the study, participants provide information on their symptom severity, treatment adherence, and quality of life at regular intervals. The research team collects data on medical history and any changes in symptoms or treatments. Participants also share their experiences with the CAMZYOS Risk Evaluation and Mitigation Strategy program. The study runs until June 2027, allowing long-term observation of patient outcomes while receiving mavacamten.
CONDITIONS
Brief Title
Real-world Patient Reported Outcomes Among Patients Treated With Camzyos
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants 18 years of age or older
- Participants who are prescribed mavacamten for obstructive hypertrophic cardiomyopathy
- Provided informed consent to participate in the study
You will not qualify if you...
- Previously or currently enrolled in clinical trials for any cardiac myosin inhibitors
- Treated for more than 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person or remote) to complete baseline assessments and confirm eligibility
Duration - Up to 96 weeks
Participants treated with mavacamten are monitored through regular surveys assessing symptoms, treatment status, and quality of life.
Surveys completed at Baseline and Weeks 2, 4, 8, 12, 24, 30, 48, 60, 72, 84, and 96
Trial Site Locations
Total: 1 location
1
Analysis Group Inc.
Boston, Massachusetts, United States, 02199
Actively Recruiting
Research Team
B
BMS Study Connect Contact Center www.BMSStudyConnect.com
F
First line of the email MUST contain NCT # and Site #.
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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