Obstructive Hypertrophic Cardiomyopathy
Conditions
Keywords
Obstructive Hypertrophic cardiomyopathy
Brief 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.
Interventions
DRUGMavacamten
As prescribed by treating physician
Sponsors
Bristol-Myers Squibb
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Participant major injury or surgery since previous survey | Weeks 2, 4, 8, 12, 24, 30, 48, 60, 72, 84 and 96 |
| 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 survey response on experience with CAMZYOS Risk Evaluation and Mitigation Strategy program (REMS) Program | Baseline and weeks 4, 12, 30, 48, 72 and 96 |
| Participant medical history | Baseline |
Countries
United States
Contacts
Primary ContactBMS Study Connect Contact Center www.BMSStudyConnect.com
Backup ContactFirst line of the email MUST contain NCT # and Site #.
Outcome results
None listed