HYPERTROPHIC CARDIOMYOPATHY OUTCOMES REGISTRY (DISCOVER-HCM)
R
Roopa Subbarao, MD
Primary Investigator
Overview
To evaluate the safety of mavacamten in patients with symptomatic obstructive hypertrophic
cardiomyopathy (obstructive HCM) in the real-world setting. The registry evaluates patient characteristics, realworld treatment patterns and short- and long-term outcomes in a population of patients with symptomatic
obstructive HCM who are receiving mavacamten, receiving other treatment for obstructive HCM, or not
receiving treatment for obstructive HCM due to intolerance or failure of prior treatment.
Description
Researchers will record relevant health information from participants' medical records to gather data. Researchers will then evaluate the data to evaluate the safety of mavacamten.
Eligibility
You may be eligible for this study if you meet the following criteria:
-
Conditions:
obstructive hypertrophic cardiomyopathy
-
Age: Between 18 Years - 100 Years
-
Gender: All
Inclusion Criteria:
- Willing and able to provide written informed consent and any required privacy authorization prior to the initiation of study procedures
- Diagnosis of obstructive HCM consistent with 2020 American Health Association/American College of Cardiology (AHA/ACC) guidelines:
- Obstructive HCM is defined clinically by the presence of increased left ventricular (LV) wall thickness ≥15 mm (or ≥13 mm with positive family history of HCM) in a non-dilated ventricular chamber that is not solely explained by abnormal loading conditions (e.g., another cardiac or systemic disease) and peak LV outflow tract gradient of ≥30 mmHg at rest or with provocation
- Has documented LVEF of ≥55% recorded by echocardiography within 6 months prior to enrollment
- Symptoms consistent with NYHA functional class II-IV
- Receiving BBs, non-DHP CCBs, disopyramide, and/or mavacamten (once available) as part of routine clinical care; or currently receiving no treatment due to intolerance or failure of prior treatment (e.g., BBs, non-DHP CCBs, or disopyramide) for obstructive HCM
Exclusion Criteria:
- Known phenocopy disease (e.g., Fabry disease, amyloidosis) or LV hypertrophy associated with hypertension
- Documentation of any fixed obstruction of the outflow tract such as aortic valve stenosis or replacement
- Prior treatment of obstructive HCM with invasive septal reduction (surgical myectomy or percutaneous alcohol septal ablation [ASA]) within 6 months prior to enrollment; participants with an unsuccessful myectomy or percutaneous ASA performed >6 months prior to enrollment may be enrolled
- Naïve to treatment for obstructive HCM (i.e., never treated with BBs, non-DHP CCBs, or disopyramide)
- Receiving an investigational therapeutic agent for obstructive HCM (e.g., myosin-inhibitors other than mavacamten) in an interventional clinical trial at patient enrollment
- Previously or currently enrolled in a long-term safety extension study of mavacamten
Updated on
28 Apr 2024.
Study ID: 15555, ECRO-BMS-DISCOVER-HCM
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