Telemedical Interventional Management in Heart Failure II (TIM-HF II)

Chronic heart failure is a widespread disease that currently affects about 1.2 million patients in Germany. With approximately 430,000 hospitalizations in 2014, it represents the most frequent reason for hospitalization. The outcome of this is the enormous charging of costs for care on these patients from the health and care insurance providers which makes around three billion euros p.a. (Statistisches Bundesamt 2015)

In a controlled, prospective health care clinical trial TIM-HF II (NCT01878630, DRKS00010239) the non-inferiority of a new ambulatory care model for underdeveloped rural area without resident cardiologists in patients with chronic heart failure (CHF) compared to regions with practicing cardiologists regarding medical health and economic effectiveness will be tested.

inclusion criteria

  • chronic heart failure New York Heart Association (NYHA) class II or III
  • echocardiographically determined left ventricular ejection fraction (LVEF) ≤45% or >45% + minimum 1 diuretic in permanent medicinal therapy
  • hospitalization due to decompensated HF within the last 12months before randomization
  • informed consent

exclusion criteria

  • 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)

 

Principal Investigator: Prof. Dr. Friedrich Koehler, MD