Status:
COMPLETED
Telemedical Interventional Management in Heart Failure II
Lead Sponsor:
Charite University, Berlin, Germany
Collaborating Sponsors:
German Federal Ministry of Education and Research
University of Leipzig
Conditions:
Chronic Heart Failure
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Superiority of additional Remote Patient Management (RPM) in patients with chronic heart failure (CHF) in comparison to usual care in terms of, e.g.: * days lost due to unplanned cardiovascular hospi...
Detailed Description
The clinical trial assesses 1,500 patients over a period of 12 months each (2013 until 2015). All participants will continue to receive usual care from their general practitioner and specialist. All p...
Eligibility Criteria
Inclusion
- 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
- Depression score PHQ-9: \<10
Exclusion
- 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)
Key Trial Info
Start Date :
August 8 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 17 2018
Estimated Enrollment :
1571 Patients enrolled
Trial Details
Trial ID
NCT01878630
Start Date
August 8 2013
End Date
May 17 2018
Last Update
August 3 2018
Active Locations (109)
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1
Klinikum St. Marien Amberg - Medizinische Klinik I
Amberg, Germany
2
GLG Fachklinik Wolletzsee GmbH
Angermünde, Germany
3
Klinik Ernst von Bergmann Bad Belzig gGmbH - Zentrum für Innere Medizin/Kardiologie
Bad Belzig, Germany, 14805
4
Oder-Spree-Krankenhaus Beeskow GmbH
Beeskow, Germany