A Study of Mavacamten in Obstructive Hypertrophic Cardiomyopathy (NCT05414175) | Clinical Trial Compass
CompletedPhase 3
A Study of Mavacamten in Obstructive Hypertrophic Cardiomyopathy
Japan38 participantsStarted 2022-08-19
Plain-language summary
The purpose of this study is to evaluate the effectiveness, safety, and tolerability of a 30-week course of mavacamten and the long-term effects of mavacamten in Japanese participants with symptomatic obstructive hypertrophic cardiomyopathy (HCM).
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Age 18 and greater, body weight ≥ 35kg
* Has adequate acoustic windows to enable accurate transthoracic echocardiograms (TTEs)
* Diagnosed with obstructive hypertrophic cardiomyopathy consistent with current American College of Cardiology Foundation/American Heart Association, European Society of Cardiology, and Japanese Circulation Society guidelines
* Has documented left ventricular ejection fraction (LVEF) ≥60% NYHA Class II or III
Exclusion Criteria:
* Known infiltrative or storage disorder causing cardiac hypertrophy that mimics oHCM, such as Fabry disease, amyloidosis, or Noonan syndrome with LV hypertrophy
* History of syncope or sustained ventricular tachyarrhythmia with exercise within 6 months prior to Screening
* History of resuscitated sudden cardiac arrest (at any time) or known history of appropriate implantable cardioverter defibrillator (ICD) discharge for life-threatening ventricular arrhythmia within 6 months prior to Screening
* Paroxysmal atrial fibrillation with atrial fibrillation present at the time of Screening.
* Persistent or permanent atrial fibrillation not on anticoagulation for at least 4 weeks prior to Screening and/or not adequately rate controlled within 6 months prior to Screening
* Treatment (within 14 days prior to Screening) or planned treatment during the study with cibenzoline, disopyramide or ranolazine
* Treatment (within 14 days prior to Screening) or planned treatment during the study with a combination of be…
What they're measuring
1
Change From Baseline in Post-exercise Left Ventricular Outflow Tract (LVOT) Peak Gradient at Week 30