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Active (not recruiting) Phase 4 NCT06112743

A Study to Evaluate Mavacamten Impact on Myocardial Structure in Participants With Symptomatic Obstructive Hypertrophic Cardiomyopathy

Phase 4 – monitoring after market approval
Conditions: Cardiomyopathy, Hypertrophic

Sponsor: Bristol-Myers Squibb

trial.available_in: БГ
Overview
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) \[New York Heart Association (NYHA) Functional Class II or III\].
Who can participate
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.
Locations 6
Argentina (1)
Local Institution - 0076
Ciudad Autónoma de Buenos Aires , Buenos Aires
Australia (1)
Local Institution - 0015
Camperdown , New South Wales
Canada (1)
Local Institution - 0001
Montreal , Quebec
Switzerland (1)
Local Institution - 0058
Lucerne , Luzern (de)
United Kingdom (1)
Local Institution - 0025
Leeds , Yorkshire
United States (1)
Local Institution - 0087
West Hollywood , California
Technical details
Status
Active (not recruiting)
Phase
Phase 4
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
24.01.2024
Completion date
09.07.2026
Registry ID
NCT06112743
Source
anzctr
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Information is automatically extracted from ClinicalTrials.gov. Consult your doctor before taking action.