Mavacamten in Symptomatic Non-Obstructive Hypertrophic Cardiomyopathy

What is the Purpose of this Study?

The purpose of this study is to determine whether treatment with a drug called mavacamten reduces shortness of breath and fatigue and increases exercise capacity in patients with non-obstructive hypertrophic cardiomyopathy (nHCM). Study procedures include review of medical history and medications, physical exams, blood draws, echocardiograms, cardiopulmonary exercise test, electrocardiograms, and questionnaires. Participants will be randomly assigned to receive either mavacamten capsules or placebo (inactive substance) capsules. Mavacamten has been approved by the U.S. Food and Drug Administration (FDA) in adults with obstructive hypertrophic cardiomyopathy (oHCM), but it is not approved for people with nHCM.


Eligibility

  • Diagnosis of HCM consistent with current American College of Cardiology Foundation/American Heart Association and European Society of Cardiology guidelines: unexplained left-ventricular hypertrophy with non-dilated ventricular chambers in the absence of other cardiac or systemic disease which can produce the required magnitude of hypertrophy of a maximal left ventricular (LV) wall thickness ≥ 15 millimeters (mm) (or ≥ 13 mm with positive family history of hypertrophic cardiomyopathy [HCM]) as determined by core laboratory interpretation.
  • Peak left ventricular outflow tract (LVOT) pressure gradient < 30 millimeters mercury (mm Hg) at rest and < 50 mm Hg with provocation (Valsalva maneuver and stress echocardiography).
  • New York Heart Association (NYHA) Class II or III.
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Where can I participate?

Beverly

More about this Clinical Trial

What is the full name of this clinical trial?

A Randomized, Double-blind, Placebo-controlled Clinical Study to Evaluate Mavacamten in Adults with Symptomatic Non-obstructive Hypertrophic Cardiomyopathy

Study Details
Disease Type/Condition

Cardiomyopathy - non-obstructive hypertrophic (nHCM)

Principal Investigator

Rader, Florian

Age Group

Adult

Phase

III

IRB Number

STUDY00002389

ClinicalTrials.gov ID

NCT05582395

Key Eligibility
ClinicalTrials.gov

How do I learn more about this study?
Email
clinicaltrials@cshs.org
Study Detail
Disease Type/Condition

Cardiomyopathy - non-obstructive hypertrophic (nHCM)

Principal Investigator

Rader, Florian

Age Group

Adult

Phase

III

IRB Number

CV027031

ClinicalTrials.gov ID

NCT05582395

Key Eligibility
ClinicalTrials.gov

Contact
Email
clinicaltrials@cshs.org