A Study of Mavacamten in Non-Obstructive Hypertrophic Cardiomyopathy (ODYSSEY-HCM)
R
Roopa Subbarao, MD
Primary Investigator
Not Recruiting
18 years or above
All
Phase
3
420 participants needed
1 Location
Brief description of study
The purpose of this study is to evaluate the safety, tolerability, and efficacy of mavacamtend with placebo in participants with symptomatic non-obstructive hypertrophicdiomyopathy (nHCM).
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Cardiomyopathy, Hypertrophic
-
Age: 18 years or above
-
Gender: All
Inclusion Criteria:
- Diagnosis of HCM consistent with current American College of CardiologyFoundation/American Heart Association and European Society of Cardiology guidelines:unexplained left-ventricular hypertrophy with non-dilated ventricular chambers in thebsence of other cardiac or systemic disease which can produce the required magnitudehypertrophy of a maximal left ventricular (LV) wall thickness ≥ 15 millimeters (mm)(or ≥ 13 mm with positive family history of hypertrophic cardiomyopathy [HCM]) asdetermined 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 stresshocardiography)
- New York Heart Association (NYHA) Class II or III
Exclusion Criteria:
- Known infiltrative or storage disorder causing cardiac hypertrophy that mimicsbstructive hypertrophic cardiomyopathy (nHCM) such as Fabry disease, amyloidosis,yndrome with LV hypertrophy
- History of unexplained syncope within 6 months prior to screening
- History of sustained ventricular tachyarrhythmia (> 30 seconds) within 6 months priorg
Additional inclusion and exclusion criteria apply.
Updated on
13 Dec 2024.
Study ID: CV027-031
