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

Bristol-Myers Squibb (BMS) logo

Bristol-Myers Squibb (BMS)

Status and phase

Active, not recruiting
Phase 4

Conditions

Cardiomyopathy, Hypertrophic

Treatments

Drug: Mavacamten

Study type

Interventional

Funder types

Industry

Identifiers

NCT06112743
CV027-1088

Details and patient eligibility

About

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].

Enrollment

85 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

85 participants in 1 patient group

Mavacamten
Experimental group
Treatment:
Drug: Mavacamten

Trial contacts and locations

12

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Central trial contact

First line of the email MUST contain NCT # and Site #.; BMS Study Connect Contact Center www.BMSStudyConnect.com

Data sourced from clinicaltrials.gov

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