JPRN-jRCT2051220175招募中3 期
A Randomized, Double-blind, Placebo-controlled Clinical Study to Evaluate Mavacamten inAdults with Symptomatic Non-obstructive Hypertrophic Cardiomyopathy
Aronson Ron0 个研究点目标入组 34 人开始时间: 2023年2月23日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 34
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 18age old 至 ot applicable（—）
- 性别
- All
入选标准
- •Diagnosis of HCM consistent with current American College of Cardiology Foundation/American Heart Association and European Society of Cardiology guidelines: unexplained left-ventricular hypertrophy with non-dilated ventricular chambers in the absence of other cardiac or systemic disease which can produce the required magnitude of hypertrophy of a maximal left ventricular (LV) wall thickness >= 15 millimeters (mm) (or >= 13 mm with positive family history of hypertrophic cardiomyopathy [HCM]) as determined by core laboratory interpretation
- •-Peak left ventricular outflow tract (LVOT) pressure gradient < 30 millimeters mercury (mm Hg) at rest and < 50 mm Hg with provocation (Valsalva maneuver and stress echocardiography)
- •-New York Heart Association (NYHA) Class II or III
排除标准
- •-Known infiltrative or storage disorder causing cardiac hypertrophy that mimics non-obstructive hypertrophic cardiomyopathy (nHCM) such as Fabry disease, amyloidosis, or Noonan syndrome with LV hypertrophy
- •-History of unexplained syncope within 6 months prior to screening
- •-History of sustained ventricular tachyarrhythmia (> 30 seconds) within 6 months prior to screening
研究者
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