The purpose of this study is to evaluate the mavacamten impact on myocardial structure with cardiac magnetic resonance imaging (CMR) in adult participants with symptomatic obstructive hypertrophic cardiomyopathy (oHCM) \[New York Heart Association (NYHA) Functional Class II or III\].
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria
* Diagnosed with obstructive hypertrophic cardiomyopathy (oHCM), in accordance with current American College of Cardiology Foundation/American Heart Association and European Society of Cardiology guidelines as below:.
* Left ventricular outflow tract (LVOT) peak gradient ≥ 30 mmHg and ≥ 50 mmHg after Valsalva or after exercise.
* Left ventricular ejection fraction (LVEF) ≥ 55% at rest.
* New York Heart Association (NYHA) functional class II or III symptoms.
Exclusion Criteria
* A known infiltrative or storage disorder causing cardiac hypertrophy that mimics oHCM.
* Documented obstructive coronary artery disease or history of myocardial infarction.
* A history of resuscitated sudden cardiac arrest or life-threatening ventricular arrhythmia within 6 months prior to screening.
* An implantable cardioverter defibrillator (ICD) or pacemaker, or another contraindication for cardiac magnetic resonance imaging (CMR).
* Other protocol-defined inclusion/exclusion criteria apply.
Primary outcome measure(s)
Composite of maximum left atrial volume index (LAVI) and left ventricular mass index (LVMI) at Week 48 — At week 48 Participants achieving both of the following criteria at Week 48 cardiac magnetic resonance imaging (CMR) assessment:
* A decrease of at least 5 mL/m2 in maximum LAVI from baseline
* A decrease of at least 5 g/m2 in LVMI from baseline
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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