Trial document

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DRKS-ID: 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?

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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

DRKS-ID: DRKS00019022
Date of Registration in DRKS: 2020/05/28
Date of Registration in Partner Registry or other Primary Registry: [---]*
Investigator Sponsored/Initiated Trial (IST/IIT): no
Ethics Approval/Approval of the Ethics Committee: Approved
(leading) Ethics Committee No.: 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

ICD10: I50 - Heart failure

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Interventions/Observational Groups

Arm 1: Intervention group: standard care + bapp based exercise training, mointoring and selfmanagement
Arm 2: control group: standard care

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Characteristics

Study Type: Interventional
Study Type Non-Interventional: [---]*
Allocation: Randomized controlled trial
Blinding: Open (masking not used)
Who is blinded: [---]*
Control: Active control (effective treament of control group)
Purpose: Health care system
Assignment: Parallel
Phase: N/A
Off-label Drug use: 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

DE: Germany

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Locations of Recruitment

Medical Center Universität Leipzig Institut für Sportmedizin und Prävention, Leipzig
Medical Center MHH Institut für Sportmedizin, Hannover

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Recruitment

Planned/Actual: Planned
(Anticipated or Actual) Date of First Enrollment: 2020/06/01
Target Sample Size: 2500
Monocenter/Multicenter trial: Multicenter trial
National/International: National

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Inclusion Criteria

Gender: Both, male and female
Minimum Age: 18 Years
Maximum Age: 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

Primary Sponsor
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- Deutsche Luft - und Raumfahrtzentrum
- Rosa-Luxemburg-Str. 2
- 10178 Berlin
- Germany
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- Telephone: [---]*
- Fax: [---]*
- E-mail: [---]*
- URL: [---]*
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Collaborator, Other Address
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- Herzzentrum Leipzig
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- Telephone: [---]*
- Fax: [---]*
- E-mail: [---]*
- URL: [---]*
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Collaborator, Other Address
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- Klinikum Chemnitz
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- E-mail: [---]*
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Collaborator, Other Address
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- Klinikum Wolfsburg
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- Telephone: [---]*
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- E-mail: [---]*
- URL: [---]*
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Collaborator, Other Address
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- AOK Plus Sachsen und Thüringen
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- Telephone: [---]*
- Fax: [---]*
- E-mail: [---]*
- URL: [---]*
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Collaborator, Other Address
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- AUDI BKK
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- Telephone: [---]*
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- E-mail: [---]*
- URL: [---]*
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Collaborator, Other Address
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- Herzzentrum Dresden
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- Telephone: [---]*
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- E-mail: [---]*
- URL: [---]*
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Contact for Scientific Queries
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- Universität LeipzigInstitut für Sportmedizin und Prävention
- Mr. Stefan Kwast
- Marschner Str. 29a
- 04109 Leipzig
- Germany
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- Telephone: 03419731660
- Fax: [---]*
- E-mail: stefan.kwast at uni-leipzig.de
- URL: http://www.universität-leipzig.de
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Contact for Public Queries
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- Institut für Sportmedizin und Prävention Unviersität Leipzig
- Mr. Christop Pökel
- Marschner Str. 29a
- 04109+ Leipzig
- Germany
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- Telephone: 03419731660
- Fax: [---]*
- E-mail: HITS-Projekt at uni-leipzig.de
- URL: [---]*
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Sources of Monetary or Material Support

Public funding institutions financed by tax money/Government funding body (German Research Foundation (DFG), Federal Ministry of Education and Research (BMBF), etc.)
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- Gemiensamer Bundesauschuss Innovationsausschuss Vertreten durch das DLR
- Rosa-Luxemburg-Str. 2
- 10178 Berlin
- Germany
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- Telephone: [---]*
- Fax: [---]*
- E-mail: [---]*
- URL: [---]*
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Status

Recruitment Status: Recruiting planned
Study Closing (LPLV): [---]*

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Trial Publications, Results and other Documents

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