Status:
COMPLETED
A Phase 2 Study of Mavacamten in Adults With Symptomatic Non-Obstructive Hypertrophic Cardiomyopathy (nHCM)
Lead Sponsor:
MyoKardia, Inc.
Conditions:
Non-obstructive Hypertrophic Cardiomyopathy
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This is a multicenter, exploratory, randomized, double-blind study of the administration of mavacamten in 60 participants with symptomatic nHCM randomized to receive a 16-week course of mavacamten dos...
Eligibility Criteria
Inclusion
- Key
- Diagnosed with nHCM (hypertrophied and non-dilated left ventricle in absence of systemic or other known cause), with LV wall thickness ≥ 15mm at Screening or ≥ 13mm with a positive family history of HCM.
- Age 18 and greater, Body weight \> 45kg
- Documented LVEF ≥ 55% at the Screening as determined by echo central lab
- LVOT gradient \< 30 mmHg at rest AND during Valsalva AND post-exercise
- NYHA functional class II or III
- Elevated NT-proBNP at rest
- Key
Exclusion
- History of syncope, sustained ventricular tachyarrhythmia with exercise, obstructive coronary artery disease or myocardial infarction within the past 6 months
- History of resuscitated sudden cardiac arrest at any time or known appropriate implantable cardioverter defibrillator (ICD) discharge within 6 months prior to Screening
- Current treatment with disopyramide or ranolazine (within 14 days prior to Screening)
- Current or planned treatment during the study with a combination of beta-blockers and calcium channel blockers
- Has been treated with invasive septal reduction (surgical myectomy or percutaneous alcohol septal ablation \[ASA\]) within 6 months prior to Screening
- History of resting or post-exercise LVOT \>30 mmHg unless subsequently treated by septal reduction
- Has QTc Fridericia (QTcF) \>480 ms or any other ECG abnormality considered by the investigator to pose a risk to participant safety (eg, second-degree atrioventricular block type II)
- Has persistent or permanent atrial fibrillation not on anticoagulation for at least 4 weeks prior to Screening and/or not adequately rate-controlled within 1 year of Screening
- History of clinically significant malignant disease within 10 years such as non-metastatic cutaneous squamous cell or basal cell carcinoma
- History or evidence of any other clinically significant disorder, condition, or disease that, in the opinion of the investigator or MyoKardia physician, would pose a risk to subject safety or interfere with the study evaluation, procedures, or completion.
Key Trial Info
Start Date :
March 30 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 7 2020
Estimated Enrollment :
59 Patients enrolled
Trial Details
Trial ID
NCT03442764
Start Date
March 30 2018
End Date
January 7 2020
Last Update
August 9 2022
Active Locations (32)
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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
Stanford Hospital and Clinics/Stanford University
Palo Alto, California, United States, 94305
4
University of California, San Francisco
San Francisco, California, United States, 94143