A Study to Evaluate Mavacamten in Adults With Symptomatic Obstructive HCM Who Are Eligible for Septal Reduction Therapy

  • End date
    Dec 16, 2024
  • participants needed
  • sponsor
    MyoKardia, Inc.
Updated on 16 September 2021


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.

Condition Hypertrophic Cardiomyopathy, hypertrophic obstructive cardiomyopathy
Treatment Placebo, mavacamten
Clinical Study IdentifierNCT04349072
SponsorMyoKardia, Inc.
Last Modified on16 September 2021


Yes No Not Sure

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/or ESC 2014 guidelines 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

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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