Hypertrophic Cardiomyopathy Clinical Trial

A Phase 2 Study of Mavacamten in Adults With Symptomatic Non-Obstructive Hypertrophic Cardiomyopathy (nHCM)

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 doses titrated to achieve 1 of 2 target drug concentrations.

View Eligibility Criteria

Eligibility Criteria

Key Inclusion Criteria:

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 Criteria:

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.

Study is for people with:

Hypertrophic Cardiomyopathy

Phase:

Phase 2

Estimated Enrollment:

59

Study ID:

NCT03442764

Recruitment Status:

Completed

Sponsor:

MyoKardia, Inc.

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There are 31 Locations for this study

See Locations Near You

Mayo Clinic Arizona
Scottsdale Arizona, 85259, United States
Cedars-Sinai Medical Center (Smidt Heart Institute)
Los Angeles California, 90048, United States
Stanford Hospital and Clinics/Stanford University
Palo Alto California, 94305, United States
University of California, San Francisco
San Francisco California, 94143, United States
Yale New Haven Hospital
New Haven Connecticut, 06520, United States
Northwestern University
Evanston Illinois, 60208, United States
St. Vincent Medical Group
Indianapolis Indiana, 46260, United States
University of Iowa Hospitals and clinics
Iowa City Iowa, 52242, United States
University of Maryland Medical System
Baltimore Maryland, 21201, United States
Brigham and Women's Hospital
Boston Massachusetts, 02115, United States
Michigan Medicine
Ann Arbor Michigan, 48109, United States
Henry Ford Hospital
Detroit Michigan, 48202, United States
Washington University School of Medicine
Saint Louis Missouri, 63110, United States
NYU Winthrop Hospital
Mineola New York, 11501, United States
NYU Langone Medical Center
New York New York, 10016, United States
Carolinas Medical Center
Charlotte North Carolina, 28203, United States
Duke Cardiology at Southpoint
Durham North Carolina, 27713, United States
University of Cincinnati Medical Center
Cincinnati Ohio, 45219, United States
Oregon Health and Science University
Portland Oregon, 97239, United States
St. Luke's Cardiology Associates
Bethlehem Pennsylvania, 18018, United States
Penn State Health Milton S. Hershey Medical Center
Hershey Pennsylvania, 17033, United States
University of Pennsylvania
Philadelphia Pennsylvania, 19104, United States
UPMC Presbyterian
Pittsburgh Pennsylvania, 15213, United States
The University of Texas Southwestern Medical Center at Dallas
Dallas Texas, 75390, United States
Baylor St. Luke Medical Center at Houston, Texas Heart Institute Out-patient Clinic
Houston Texas, 77030, United States
Houston Methodist Hospital
Houston Texas, 77030, United States
Intermountain Medical Center
Murray Utah, 84107, United States
University of Utah Medical Center
Salt Lake City Utah, 84132, United States
University of Virginia
Charlottesville Virginia, 22908, United States
Virginia Commonwealth University
Richmond Virginia, 23298, United States
University of Washington Medical Center
Seattle Washington, 98195, United States
Unity Point Health Meriter Heart and Vascular Institute
Madison Wisconsin, 53713, United States

How clear is this clinincal trial information?

Study is for people with:

Hypertrophic Cardiomyopathy

Phase:

Phase 2

Estimated Enrollment:

59

Study ID:

NCT03442764

Recruitment Status:

Completed

Sponsor:


MyoKardia, Inc.

How clear is this clinincal trial information?

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