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The purpose of this study is to understand the real-world clinical outcomes and treatment patterns of adults with obstructive hypertrophic cardiomyopathy (HCM) treated with mavacamten, and to understand patient and physician experiences with mavacamten treatment, in the US community-based practice
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Participants with obstructive hypertrophic cardiomyopathy (oHCM) receiving mavacamten |
| |
| Group 2 | Physicians treating patients diagnosed with obstructive hypertrophic cardiomyopathy (oHCM) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mavacamten | Drug | According to the product label |
|
| Measure | Description | Time Frame |
|---|---|---|
| Participant blood pressure (both systolic and diastolic) | Group 1 only | Baseline |
| Date of diagnosis of hypertrophic cardiomyopathy | Group 1 only | Baseline |
| Hypertrophic cardiomyopathy genetic testing results | Group 1 only | Baseline |
| Family history of hypertrophic cardiomyopathy | Group 1 only | Baseline |
| Family history of Sudden Cardiac Death (SCD) | Group 1 only | Baseline |
| Participant comorbidities (cardiovascular and non-cardiovascular ) | Group 1 only | Baseline |
| Type of prior surgeries and procedures | Group 1 only. Prior surgeries and procedures include: Septal Reduction Therapy (SRT), surgeries (valve repair/placement, left atrial appendage ligation), placement of devices (Implantable Cardioverter Defibrillator (ICD), pacemaker and cardiac resynchronization therapy) or atrial fibrillation/flutter ablation | Baseline and up to week 24 |
| Participant New York Heart Association (NYHA) class category | Group 1 only |
| Measure | Description | Time Frame |
|---|---|---|
| Perspectives on treatment preference, and the eligibility, onboarding and implementation of mavacamten as assessed by feedback collated through structured physician interviews | Group 2 only | Up to week 24 |
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Inclusion Criteria:
Phase I: retrospective chart review
For inclusion in the study, participants must meet ALL of the following criteria:
Phase II: patient survey • Participants must meet all inclusion criteria of Phase I: retrospective chart review and be able to read and understand English and have access to computer or smartphone to complete the survey
Exclusion Criteria:
• None with the proviso that all inclusion criteria are met.
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The study population will consist of adults that have been diagnosed with obstructive hypertrophic cardiomyopathy (HCM) and have received treatment with mavacamten and their treating clinicians from participating community-based sites in the US.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| BMS Clinical Trials Contact Center www.BMSClinicalTrials.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 |
|---|---|---|---|---|---|---|
| Adelphi Real World | Recruiting | Bollington | Macclesfield | SK10 5JB | United Kingdom |
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| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
| FDA Safety Alerts and Recalls | View source |
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| ID | Term |
|---|---|
| D002312 | Cardiomyopathy, Hypertrophic |
| ID | Term |
|---|---|
| D009202 | Cardiomyopathies |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001020 | Aortic Stenosis, Subvalvular |
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| ID | Term |
|---|---|
| C000605992 | MYK-461 |
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| Baseline, and at weeks 4, 8, 12, 24 |
| Change in participant New York Heart Association (NYHA) class from baseline | Group 1 only | Baseline, and at weeks 4, 8, 12, 24 |
| Duration of mavacamten treatment | Group 1 only | Baseline, and at weeks 4, 8, 12, 24 |
| Number of mavacamten dose titrations | Group 1 only | Baseline, and at weeks 4, 8, 12, 24 |
| Type of mavacamten dose tritration | Group 1 only | Baseline, and at weeks 4, 8, 12, 24 |
| Clinical reason for mavacamten dose titration | Group 1 only | Baseline, and at weeks 4, 8, 12, 24 |
| Clinical reason for mavacamten treatment discontinuation | Group 1 only | Baseline, and at weeks 4, 8, 12, 24 |
| Left Ventricular Ejection Fraction (LVEF) recovery after mavacamten discontinuation if discontinued due to LVEF<50%, | Group 1 only | Baseline, and at weeks 4, 8, 12, 24 |
| Time from mavacamten discontinuation to Left Ventricular Ejection Fraction (LVEF) recovery | Group 1 only | Baseline, and at weeks 4, 8, 12, 24 |
| Clinical reason for temporary mavacamten treatment interuption | Group 1 only | Baseline, and at weeks 4, 8, 12, 24 |
| Time to temporary mavacamten treatment interruption | Group 1 only | Baseline, and at weeks 4, 8, 12, 24 |
| Left Ventricular Ejection Fraction (LVEF) recovery after mavacamten interruption if the interruption was due to LVEF<50% | Group 1 only | Baseline, and at weeks 4, 8, 12, 24 |
| Time from mavacamten treatment interruption to Left Ventricular Ejection Fraction (LVEF) recovery | Group 1 only | Baseline, and at weeks 4, 8, 12, 24 |
| Time to mavacamten treatment resumption | Group 1 only | Baseline, and at weeks 4, 8, 12, 24 |
| Type of hypertrophic cardiomyopathy (HCM) background therapy prescribed | Group 1 only | Baseline, and at weeks 4, 8, 12, 24 |
| Type of changes to hypertrophic cardiomyopathy (HCM) background therapy | Group 1 only. Type of changes include initiation, switching, discontinuation, augmentation, dose titration | At baseline, weeks 4, 8, 12, 24 |
| D001024 |
| Aortic Valve Stenosis |
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |