跳至主要内容
临床试验/DRKS00010239
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

发起方
Charité Campus Charité Mitte

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