Status:
COMPLETED
Clinical Study to Evaluate Mavacamten (MYK-461) in Adults With Symptomatic Obstructive Hypertrophic Cardiomyopathy
Lead Sponsor:
MyoKardia, Inc.
Conditions:
Obstructive Hypertrophic Cardiomyopathy
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This is a multicenter, international, double-blind study of the administration of mavacamten in participants with symptomatic obstructive HCM (oHCM). Approximately 220 participants will be randomized ...
Eligibility Criteria
Inclusion
- Key
- Age 18 and greater, body weight ≥ 45kg
- Has adequate acoustic windows to enable accurate transthoracic echocardiograms (TTEs)
- Diagnosed with oHCM consistent with current American College of Cardiology Foundation/American Heart Association and European Society of Cardiology guidelines and satisfy both criteria:
- Has documented left ventricular ejection fraction (LVEF) ≥55%
- NYHA Class II or III
- Has documented oxygen saturation at rest ≥90% at Screening
- Is able to perform an upright CPET and has a respiratory exchange ratio (RER) ≥1.0 at Screening per central reading
- Key
Exclusion
- 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, intermittent atrial fibrillation with atrial fibrillation present at 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 disopyramide or ranolazine
- Treatment (within 14 days prior to Screening) or planned treatment during the study with a combination of β-blockers and calcium channel blockers
- LVOT gradient with Valsalva maneuver \<30 mmHg at Screening
- Has been successfully treated with invasive septal reduction (surgical myectomy or percutaneous alcohol septal ablation \[ASA\]) within 6 months prior to Screening or plans to have either of these treatments during the study
- ICD placement within 2 months prior to Screening or planned ICD placement during the study
- Has a history or evidence of any other clinically significant disorder, condition, or disease that, in the opinion of the investigator, would pose a risk to participant safety or interfere with the study evaluation, procedures, or completion
- Prior treatment with cardiotoxic agents such as doxorubicin or similar
Key Trial Info
Start Date :
May 29 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 6 2020
Estimated Enrollment :
251 Patients enrolled
Trial Details
Trial ID
NCT03470545
Start Date
May 29 2018
End Date
May 6 2020
Last Update
October 4 2021
Active Locations (71)
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1
Mayo Clinic Arizona
Scottsdale, Arizona, United States, 85259
2
Cedars-Sinai Medical Center (Smidt Heart Institute)
Los Angeles, California, United States, 90048
3
UCSF School of Medicine
San Francisco, California, United States, 94143
4
Stanford University
Stanford, California, United States, 94305