DRKS00010239已完成3 期
Telemedical Interventional Management in Heart Failure II - TIM-HF2
Charité Campus Charité Mitte0 个研究点目标入组 1,571 人开始时间: 2016年4月1日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,571
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 one(—)
- 性别
- All
入选标准
- •1. chronic heart failure New York Heart Association (NYHA) class II or III; 2. echocardiographically determined left ventricular ejection fraction (LVEF) =45% or >45% + minimum 1 diuretic in permanent medicinal therapy;
- •3. hospitalization due to decompensated HF within the last 12months before randomization; 4. informed consent; 5. depression score (PHQ-9 <10)
排除标准
- •Hospitalization within the last 7 days before randomization; Implanted cardiac assist system
- •Acute coronary syndrome within the last 7 days before randomization; High urgent listed for heart transplantation (HTx); Planned revascularization, Transcatheter Aortic Valve Implantation (TAVI), MitraClip and/or Cardiac Resynchronization Therapy (CRT)-implantation within the last 3 months before randomization
- •Revascularization and/or CRT-implantation within 28 days before randomization;
- •Known alcohol or drug abuse; Terminal renal insufficiency with hemodialysis;
- •Impairment or unwillingness to use the telemonitoring equipment (e.g. dementia, impaired self-determination, lacking ability to communicate); Existence of any disease reducing life expectancy to less than 1 year; Age <18 years; Pregnancy; Participation in other treatment studies or remote patient management programmes (register studies possible)
研究者
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