Hypertrophic Cardiomyopathy Clinical Trial
A Study to Evaluate Mavacamten in Adults With Symptomatic Obstructive HCM Who Are Eligible for Septal Reduction Therapy
Summary
This is a randomized, double-blind, placebo-controlled, multi-center study in the United States (U.S.) that will evaluate the effect of mavacamten treatment on reducing the number of septal reduction therapy (SRT) procedures performed in subjects with symptomatic obstructive hypertrophic cardiomyopathy (oHCM [also known as HOCM]) who are eligible for SRT based on ACCF/AHA 2011 and/or ESC 2014 guidelines.
Eligibility Criteria
Key Inclusion Criteria:
At least 18 years old at screening and body weight > 45 kg at screening
Diagnosed with oHCM consistent with current ACCF/AHA 2011 and meet their recommendations for invasive therapies
Referred or under active consideration within the past 12 months for SRT procedure and willing to have SRT procedure
Has documented left ventricular ejection fraction (LVEF) ≥ 60% at Screening
Has documented oxygen saturation at rest ≥ 90% at Screening
Key Exclusion Criteria:
Persistent or permanent atrial fibrillation and subject not on anticoagulation for ≥ 4 weeks prior to screening and/or not adequately rate controlled ≤ 6 months prior to screening
Previously treated with invasive septal reduction (surgical myectomy or percutaneous alcohol septal ablation [ASA])
For individuals on beta blockers, calcium channel blockers, or disopyramide, any dose adjustment of these medications < 14 days prior to screening or an anticipated change in regimen during the first 16 weeks of the study
Any medical condition that precludes upright exercise stress testing
Paroxysmal, intermittent atrial fibrillation with atrial fibrillation present at screening
Prior treatment with cardiotoxic agents, such as doxorubicin or similar
Has a history or evidence of any other clinically significant disorder, condition, or disease that would pose a risk to subject safety or interfere with the study evaluation, procedures, or completion
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There are 21 Locations for this study
Los Angeles California, 90027, United States
Stanford California, 94305, United States
New Haven Connecticut, 06520, United States
Weston Florida, 33331, United States
Boston Massachusetts, 02114, United States
Boston Massachusetts, 02115, United States
Ann Arbor Michigan, 48109, United States
Grand Rapids Michigan, 49503, United States
Rochester Minnesota, 55905, United States
Saint Louis Missouri, 63110, United States
New York New York, 10016, United States
Valhalla New York, 10595, United States
Durham North Carolina, 27710, United States
Cleveland Ohio, 44195, United States
Portland Oregon, 97239, United States
Philadelphia Pennsylvania, 19104, United States
Pittsburgh Pennsylvania, 15212, United States
Nashville Tennessee, 37205, United States
Nashville Tennessee, 37235, United States
Houston Texas, 77030, United States
Murray Utah, 84107, United States
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