Assessing health changes in patients with obstructive hypertrophic cardiomyopathy treated with mavacamten
Real-World Camzyos Patient Reported OutcoMes Through PAtient SurveyS in Hypertrophic CardioMyopathy (COMPASS-HCM): A Prospective Longitudinal Study
Bristol-Myers Squibb · NCT06551129
This study is testing how well the medication mavacamten helps adults with obstructive hypertrophic cardiomyopathy feel and do better in their everyday lives.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 118 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Bristol-Myers Squibb (industry) |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT06551129 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate real-world patient-reported outcomes in individuals diagnosed with symptomatic obstructive hypertrophic cardiomyopathy who are receiving treatment with mavacamten. Participants aged 18 and older will be monitored for changes in their health status after starting the medication. The study will gather data on their experiences and outcomes to better understand the effectiveness of mavacamten in a real-world setting.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who have been prescribed mavacamten for obstructive hypertrophic cardiomyopathy.
Not a fit: Patients who have recently participated in clinical trials for cardiac myosin inhibitors or have significant recent cardiac or lung health issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the effectiveness of mavacamten for improving health outcomes in patients with obstructive hypertrophic cardiomyopathy.
How similar studies have performed: While this study focuses on real-world outcomes, similar studies assessing patient-reported outcomes in other conditions have shown promising results, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Boston, Massachusetts
- Analysis Group Inc. — Boston, Massachusetts, United States (RECRUITING)
Study contacts
- Study coordinator: BMS Study Connect Contact Center www.BMSStudyConnect.com
- Email: Clinical.Trials@bms.com
- Phone: 855-907-3286
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Obstructive Hypertrophic Cardiomyopathy, Obstructive Hypertrophic cardiomyopathy