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Pesquisa Study Connect
  • NCT06112743

Recruiting

A Study to Evaluate Mavacamten Impact on Myocardial Structure in Participants With Symptomatic Obstructive Hypertrophic Cardiomyopathy - CV027-1088

Atualizado: 10 maio, 2024   |   ClinicalTrials.gov

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Detalhes do estudo

  • Phase 4

    Fase

  • Gênero(s)

  • 18+

    Faixa etária

  • 9

    Localização(ões)

  • Recruiting

Opções de tratamento

Braços de tratamento do Estudo
INTERVENÇÃO ATRIBUÍDA
Experimental: Mavacamten
Drug: Mavacamten
Placebo Comparator: Placebo
Other: Placebo

Principais critérios de elegibilidade

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 mm Hg and ≥ 50 mm Hg 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) Note: Other protocol-defined inclusion/exclusion criteria apply

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