jRCT2080222593未知2 期
Phase II clinical study of TY-0201 in patients with chronic heart failure
适应症
试验速览
- 阶段
- 2 期
- 入组人数
- 40
- 主要终点
- -
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 干预模型
- Multicenter, Open-label study
入排标准
- 年龄范围
- 20age old over 至 80age old under（—）
- 性别
- All
入选标准
- •Patients with chronic heart failure due to ischemic heart disease, dilated cardiomyopathy or dilated phase of hypertrophic cardiomyopathy.
- •New York Heart Association (NYHA) class I, II or III.
- •Patients diagnosed with chronic heart failure and confirmed =< 40 % of left ventricular ejection fraction (LVEF) before the day of informed consent.
- •Patients whose medication for chronic heart failure has been optimized without any change of the dosage and administration.
- •Outpatients
排除标准
- •Patients without the implantation of pacemaker and whose pulse rate are < 50 beats/min.
- •Systolic blood pressure < 90 mmHg.
- •Patients with complication of hypertrophic obstructive cardiomyopathy, cardiogenic shock, severe valve stenosis or valve regurgitation, severe or multiple arrhythmia, or secondary cardiomyopathy with rapid deterioration.
- •Patients with poor skin condition at the patch application site or history of dermatitis due to a topical agent, etc.
结局指标
主要结局
-
The change in LVEF
次要结局
未报告次要终点
研究者
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