NCT06551129Recruiting
Real-world Patient Reported Outcomes Among Patients Treated With Camzyos
Bristol-Myers Squibb
Start Date
5/10/2024
Completion Date
6/30/2027
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
Age Range: 18 years to No maximum
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
Interventions
DRUG
Mavacamten
Conditions
Obstructive Hypertrophic Cardiomyopathy
Locations
Analysis Group Inc.
Boston, Massachusetts 02199
United States