A Comparative Study of the Effects of Selective Myosin Inhibitors Mavacamten and Cibenzoline on Exercise Tolerance in Patients with Obstructive Hypertrophic Cardiomyopathy

未提供0 个研究点目标入组 45 人开始时间: 待定

试验速览

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•Patients aged 20 years or older
•Patients with symptomatic obstructive hypertrophic cardiomyopathy (left ventricular maximum wall thickness >=15 mm, or >=13 mm with a family history, and left ventricular pressure gradient >=30 mmHg at rest or during exercise)
•Patients with a baseline left ventricular ejection fraction (LVEF) >=55% on echocardiography
•Patients taking sibenzoline for at least 2 weeks in addition to beta-blockers or calcium channel blockers at baseline
•Individuals for whom consent for participation in this study was obtained via signed informed consent form by the subject or legal representative
•Patients capable of undergoing cardiopulmonary exercise testing using a seated cycle ergometer

•Patients with a history of drug hypersensitivity to macamute and for whom continued oral administration of macamute is considered difficult.
•Patients with a history of syncope or sustained ventricular tachycardia during exertion within 6 months prior to screening.
•Patients with a history of cardiac arrest or appropriate implantable cardioverter-defibrillator (ICD) activation within 6 months prior to screening.
•Patients with persistent atrial fibrillation at screening who have not received anticoagulant therapy for at least 4 weeks or who have not achieved adequate rate control (heart rate > 110 beats/min).
•Patients who underwent septal ablation therapy within 6 months prior to screening.
•Patients with NYHA functional class IV.
•Patients with Child-Pugh class C hepatic impairment.
•Patients with symptomatic chronic obstructive pulmonary disease or symptomatic restrictive pulmonary disease.
•Breastfeeding women.
•Pregnant women or women who may be pregnant.
•Patients presenting cardiac hypertrophy associated with the following conditions:
•Hypertensive heart disease, valvular heart disease, congenital heart disease, ischemic heart disease, endocrine heart disease, anemia, cor pulmonale, patients with specific cardiomyopathies*
•Other patients deemed inappropriate for study participation by the principal investigator (or co-investigator)

发起方

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