2022-502316-36-00已完成4 期
MEMENTO-A Phase 3b/4 Randomized, Double-blind, Placebo-controlled 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)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 105
- 试验地点
- 49
- 主要终点
- To evaluate the efficacy of mavacamten on both the reduction in heart wall thickness and upper chamber size at week 48 on cardiac magnetic resonance (CMR).
研究概览
简要总结
The purpose of this study is to see if mavacamten treatment reduces the heart wall (ventricle) thickness and size of the upper heart chamber (atria) on imaging studies by cardiac magnetic resonance (CMR).
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •This trial will assess elegible adults with symptomatic oHCM (NYHA Funtional Class II or III)
排除标准
- •Adults with no symptomatic oHCM (NYHA Funtional Class II or III)
结局指标
主要结局
To evaluate the efficacy of mavacamten on both the reduction in heart wall thickness and upper chamber size at week 48 on cardiac magnetic resonance (CMR).
To evaluate the efficacy of mavacamten on both the reduction in heart wall thickness and upper chamber size at week 48 on cardiac magnetic resonance (CMR).
次要结局
- To evaluate the impact of mavacamten treatment: on improvement of heart failure class in symptomatic oHCM (New York Heart Association [NYHA] Functional Class) as well as monitor for other cardiac events as a safety assessment.
研究者
研究点 (49)
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