Trial document




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  DRKS00019022

Trial Description

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Title

HITS Heart Failure Individual Training Telemonitoring and Selfmanagment

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Trial Acronym

HITS

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URL of the Trial

http://herzinsuffizienz-online.de

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Brief Summary in Lay Language

[---]*

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Brief Summary in Scientific Language

Risk patients of HF (NYHA I, RCT A) and patients with known HF (NYHAII, RCT B) are randomized to intervention or control group. The overall aim of the study is to improve the care of patients with heart failure. The Intervention period is 12 month in both RCTs.
The primary study endpoints are:
NYHA I: Patients in the IG have a 20% higher VO2max at 12 months after program end compared to the KG
NYHA II/III: Patients in the IG are 30% less likely hospitalized for HF-related conditions in the 12 months after inclusion than patients in the KG

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Do you plan to share individual participant data with other researchers?

No

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Description IPD sharing plan:

The publication of data is carried out according to the requirements of the sponsor and scientific practice.

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Organizational Data

  •   DRKS00019022
  •   2020/05/28
  •   [---]*
  •   no
  •   Approved
  •   479/19-ek, Ethikkommission an der Medizinischen Fakultät der Universität Leipzig
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Secondary IDs

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Health Condition or Problem studied

  •   I50 -  Heart failure
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Interventions/Observational Groups

  •   Intervention group: standard care + bapp based exercise training, mointoring and selfmanagement
  •   control group: standard care
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Active control (effective treament of control group)
  •   Health care system
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

NYHA I: Patients in the IG have a 20% higher VO2max at 12 months after program end compared to the KG
NYHA II/III: Patients in the IG are 30% less likely hospitalized for HF-related conditions in the 12 months after inclusion than patients in the KG

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Secondary Outcome

1. improvement of the echocardiographic HF related values
2. lower NT-proBNP values
3. improvement of vascular function in the FMD method
4. improvement of concomitant diseases
5. improving the quality of life
6. improvement of drug adherence

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
  • Medical Center 
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Recruitment

  •   Planned
  •   2020/06/01
  •   2500
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

- the presence of an NYHA class (II and III)
- a sufficient constellation of symptoms and risk factors (screening NYHA I)

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Exclusion Criteria

- Insufficient cognitive skills to participate in the programme
- expected low compliance
- Constellation of symptoms with contraindication to exercise therapy
- Participation in other studies

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Addresses

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    • Deutsche Luft - und Raumfahrtzentrum
    • Rosa-Luxemburg-Str. 2
    • 10178  Berlin
    • Germany
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    • Herzzentrum Leipzig
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    • Klinikum Chemnitz
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    • Klinikum Wolfsburg
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    • AOK Plus Sachsen und Thüringen
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    • AUDI BKK
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    • Herzzentrum Dresden
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    • Universität LeipzigInstitut für Sportmedizin und Prävention
    • Mr.  Stefan  Kwast 
    • Marschner Str. 29a
    • 04109  Leipzig
    • Germany
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    • Institut für Sportmedizin und Prävention Unviersität Leipzig
    • Mr.  Christop  Pökel 
    • Marschner Str. 29a
    • 04109+  Leipzig
    • Germany
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Sources of Monetary or Material Support

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    • Gemiensamer Bundesauschuss Innovationsausschuss Vertreten durch das DLR
    • Rosa-Luxemburg-Str. 2
    • 10178  Berlin
    • Germany
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Status

  •   Recruiting planned
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.