Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mavacamten | Adult participants with symptomatic obstructive hypertrophic cardiomyopathy treated with mavacamten |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mavacamten | Drug | As prescribed by treating physician |
|
| Measure | Description | Time Frame |
|---|---|---|
| Participant Hypertrophic Cardiomyopathy symptoms as assessed by Hypertrophic Cardiomyopathy Symptom Questionnaire (HCMSQ v2,0 - 7-day recall version) | 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) | Baseline and weeks 2, 4, 8, 12, 24, 30, 48, 60, 72, 84 and 96 | |
| Participant mavacamten treatment status | Weeks 2, 4, 8, 12, 24, 30, 48, 60, 72, 84 and 96 | |
| Other pharmacological and surgical treatments for obstructive hypertrophic cardiomyopathy (HCM) | 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 | 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) | Weeks 2, 4, 8, 12, 24, 30, 48, 72, and 96 | |
| Participant septal reduction therapy | Baseline and weeks 12, 30, 48 and 96 | |
| Participant major injury or surgery since previous survey | 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 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Adult participants in the United States diagnosed with obstructive hypertrophic cardiomyopathy (oHCM) receiving mavacamten treatment
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| BMS Study Connect Contact Center www.BMSStudyConnect.com | Contact | 855-907-3286 | Clinical.Trials@bms.com | |
| First line of the email MUST contain NCT # and Site #. | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Analysis Group Inc. | Recruiting | Boston | Massachusetts | 02199 | United States |
Not provided
| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
| FDA Safety Alerts and Recalls | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D002312 | Cardiomyopathy, Hypertrophic |
| ID | Term |
|---|---|
| D009202 | Cardiomyopathies |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001020 | Aortic Stenosis, Subvalvular |
Not provided
Not provided
| ID | Term |
|---|---|
| C000605992 | MYK-461 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Baseline and weeks 4, 12, 30, 48, 72 and 96 |
| Participant medical history | Baseline |
| D001024 |
| Aortic Valve Stenosis |
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |