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Purpose

The purpose of this study is to evaluate the mavacamten impact on myocardial structure with cardiac magnetic resonance imaging (CMR) in adult participants with symptomatic obstructive hypertrophic cardiomyopathy (oHCM) [New York Heart Association (NYHA) Functional Class II or III].

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Diagnosed with obstructive hypertrophic cardiomyopathy (oHCM), in accordance with current American College of Cardiology Foundation/American Heart Association and European Society of Cardiology guidelines as below:. - Left ventricular outflow tract (LVOT) peak gradient ≥ 30 mmHg and ≥ 50 mmHg after Valsalva or after exercise. - Left ventricular ejection fraction (LVEF) ≥ 55% at rest. - New York Heart Association (NYHA) functional class II or III symptoms.

Exclusion Criteria

  • A known infiltrative or storage disorder causing cardiac hypertrophy that mimics oHCM. - Documented obstructive coronary artery disease or history of myocardial infarction. - A history of resuscitated sudden cardiac arrest or life-threatening ventricular arrhythmia within 6 months prior to screening. - An implantable cardioverter defibrillator (ICD) or pacemaker, or another contraindication for cardiac magnetic resonance imaging (CMR). - Other protocol-defined inclusion/exclusion criteria apply.

Study Design

Phase
Phase 4
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Mavacamten
  • Drug: Mavacamten
    Specified dose on specified days

Recruiting Locations

Cedars Sinai Medical Center - 1207 San Vicente Blvd
Los Angeles, California 90048
Contact:
Florian Rader, Site 0087
310-967-3846

Piedmont Hospital
Atlanta, Georgia 30309
Contact:
Rahul Loungani, Site 0003
803-553-1103

Massachusetts General Hospital
Boston, Massachusetts 02114
Contact:
Albree Tower-Rader, Site 0093
617-724-5434

University Hospitals Cleveland Medical Center - 11100 Euclid Ave
Cleveland, Ohio 44106
Contact:
Imran Rashid, Site 0090
216-844-3800

Allegheny General Hospital
Pittsburgh, Pennsylvania 15212-4756
Contact:
Victor Farah, Site 0086
901-484-8358

Houston Methodist Hospital
Houston, Texas 77030
Contact:
Sherif Nagueh, Site 0017
713-441-2850

More Details

NCT ID
NCT06112743
Status
Recruiting
Sponsor
Bristol-Myers Squibb

Study Contact

BMS Study Connect Contact Center www.BMSStudyConnect.com
855-907-3286
Clinical.Trials@bms.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.

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Vanderbilt University Medical Center