Obstructive Hypertrophic Cardiomyopathy (oHCM)
Conditions
Keywords
Obstructive Hypertrophic cardiomyopathy (oHCM)
Brief summary
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
Interventions
DRUGMavacamten
According to the product label
Sponsors
Bristol-Myers Squibb
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Phase I: retrospective chart review For inclusion in the study, participants must meet ALL of the following criteria: * Are an adult aged 18 or over at baseline * Have a confirmed diagnosis of obstructive hypertrophic cardiomyopathy (HCM) * Have been prescribed mavacamten for obstructive HCM at one of the study sites between 28th April 2022 and 31st December 2024 * Have not ever been enrolled in any interventional clinical trial involving any cardiac myosin inhibitor (enrollment in observational studies is permitted) * Are not enrolled in any interventional clinical trial at study baseline 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Participant blood pressure (both systolic and diastolic) | Baseline | Group 1 only |
| Date of diagnosis of hypertrophic cardiomyopathy | Baseline | Group 1 only |
| Hypertrophic cardiomyopathy genetic testing results | Baseline | Group 1 only |
| Family history of hypertrophic cardiomyopathy | Baseline | Group 1 only |
| Family history of Sudden Cardiac Death (SCD) | Baseline | Group 1 only |
| Participant comorbidities (cardiovascular and non-cardiovascular ) | Baseline | Group 1 only |
| Type of prior surgeries and procedures | Baseline and up to week 24 | 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 |
| Participant New York Heart Association (NYHA) class category | Baseline, and at weeks 4, 8, 12, 24 | Group 1 only |
| Change in participant New York Heart Association (NYHA) class from baseline | Baseline, and at weeks 4, 8, 12, 24 | Group 1 only |
| Duration of mavacamten treatment | Baseline, and at weeks 4, 8, 12, 24 | Group 1 only |
| Number of mavacamten dose titrations | Baseline, and at weeks 4, 8, 12, 24 | Group 1 only |
| Type of mavacamten dose tritration | Baseline, and at weeks 4, 8, 12, 24 | Group 1 only |
| Clinical reason for mavacamten dose titration | Baseline, and at weeks 4, 8, 12, 24 | Group 1 only |
| Clinical reason for mavacamten treatment discontinuation | Baseline, and at weeks 4, 8, 12, 24 | Group 1 only |
| Left Ventricular Ejection Fraction (LVEF) recovery after mavacamten discontinuation if discontinued due to LVEF<50%, | Baseline, and at weeks 4, 8, 12, 24 | Group 1 only |
| Time from mavacamten discontinuation to Left Ventricular Ejection Fraction (LVEF) recovery | Baseline, and at weeks 4, 8, 12, 24 | Group 1 only |
| Clinical reason for temporary mavacamten treatment interuption | Baseline, and at weeks 4, 8, 12, 24 | Group 1 only |
| Time to temporary mavacamten treatment interruption | Baseline, and at weeks 4, 8, 12, 24 | Group 1 only |
| Left Ventricular Ejection Fraction (LVEF) recovery after mavacamten interruption if the interruption was due to LVEF<50% | Baseline, and at weeks 4, 8, 12, 24 | Group 1 only |
| Time from mavacamten treatment interruption to Left Ventricular Ejection Fraction (LVEF) recovery | Baseline, and at weeks 4, 8, 12, 24 | Group 1 only |
| Time to mavacamten treatment resumption | Baseline, and at weeks 4, 8, 12, 24 | Group 1 only |
| Type of hypertrophic cardiomyopathy (HCM) background therapy prescribed | Baseline, and at weeks 4, 8, 12, 24 | Group 1 only |
| Type of changes to hypertrophic cardiomyopathy (HCM) background therapy | At baseline, weeks 4, 8, 12, 24 | Group 1 only. Type of changes include initiation, switching, discontinuation, augmentation, dose titration |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Perspectives on treatment preference, and the eligibility, onboarding and implementation of mavacamten as assessed by feedback collated through structured physician interviews | Up to week 24 | Group 2 only |
Countries
United Kingdom
Contacts
CONTACTBMS Clinical Trials Contact Center www.BMSClinicalTrials.com
CONTACTFirst line of the email MUST contain NCT # and Site #.
STUDY_DIRECTORBristol-Myers Squibb
Bristol-Myers Squibb
Outcome results
None listed