JPRN-jRCT2031220178进行中（未招募）3 期
A Phase 3, Open-label, Single Arm, Clinical Study to Evaluate Efficacy, Safetyand Tolerability of Mavacamten in Adults With Symptomatic ObstructiveHypertrophic Cardiomyopathy
Florea Victoria0 个研究点目标入组 30 人开始时间: 2022年7月2日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 30
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
- •Age 18 and greater, body weight >- 35kg
- •- Has adequate acoustic windows to enable accurate transthoracic echocardiograms (TTEs)
- •- Diagnosed with obstructive hypertrophic cardiomyopathy consistent with current American College of Cardiology Foundation/American Heart Association, European Society of Cardiology, and Japanese Circulation
- •Society guidelines
- •- Has documented left ventricular ejection fraction (LVEF) >-60% NYHA Class II or III
排除标准
- •- Known infiltrative or storage disorder causing cardiac hypertrophy that
- •mimics oHCM, such as Fabry disease, amyloidosis, or Noonan syndrome
- •with LV hypertrophy
- •- History of syncope or sustained ventricular tachyarrhythmia with exercise within 6 months prior to Screening
- •- History of resuscitated sudden cardiac arrest (at any time) or known history of appropriate implantable cardioverter defibrillator (ICD) discharge for lifethreatening ventricular arrhythmia within 6 months prior to Screening
- •- Paroxysmal atrial fibrillation with atrial fibrillation present at the time of Screening.
- •- Persistent or permanent atrial fibrillation not on anticoagulation for at least 4 weeks prior to Screening and/or not adequately rate controlled within 6 months prior to Screening
- •- Treatment (within 14 days prior to Screening) or planned treatment during
- •the study with cibenzoline, disopyramide or ranolazine
- •- Treatment (within 14 days prior to Screening) or planned treatment during the study with a combination of beta blockers and verapamil or a combination of beta blockers and diltiazem
- •- Has been successfully treated with invasive septal reduction (surgical myectomy or percutaneous alcohol septal ablation [ASA]) within 6 months prior to Screening or plans to have either of these treatments during the
- •- ICD placement within 2 months prior to Screening or planned ICD placement during the study
- •- Has a history or evidence of any other clinically significant disorder, condition, or disease that, in the opinion of the investigator, would pose a risk to participant safety or interfere with the study evaluation procedures, or completion
- •- Prior treatment with cardiotoxic agents such as doxorubicin or similar
研究者
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