MEMENTO - A Phase 4, Single-arm, Open-label Clinical Study to Evaluate Mavacamten in Adults With Symptomatic Obstructive Hypertrophic Cardiomyopathy to Assess the Impact on Myocardial Structure With Cardiac Magnetic Resonance Imaging (CMR)

Activo, no reclutaFase 4ClinicalTrials.gov

ID: NCT06112743Tipo: INTERVENTIONALInicio: 24 de ene de 2024Fin estimado: 9 de jul de 2026

Traducción no disponible, mostrando original

Resumen

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) \[New York Heart Association (NYHA) Functional Class II or III\].

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

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.

Criterios de exclusión

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).

Intervenciones

drug

Mavacamten

Specified dose on specified days

Ubicaciones

Local Institution - 0076

Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina

Local Institution - 0075

Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina

Local Institution - 0079

Pilar, Buenos Aires, Argentina

Local Institution - 0077

Córdoba, Córdoba Province, Argentina

Local Institution - 0074

Rosario, Santa Fe Province, Argentina

Local Institution - 0080

Buenos Aires, Argentina

Patrocinadores

PrincipalBristol-Myers Squibb

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