Trial document




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  DRKS00015802

Trial Description

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Title

HiGHmed - Use Case Cardiology (HiGHmed-UCC) - Establishment of a registry of patients with chronic heart failure as a part of the "HiGHmed-consortium"

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Trial Acronym

HiGHmed-UCC

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URL of the Trial

[---]*

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Brief Summary in Lay Language

HiGHmed is one of four consortia funded by the Federal Ministry of Education and Research (BMBF) under the “Medical Informatics” funding scheme as part of the Medical Informatics Initiative. Together with partners from industry and research, standardized methods in the form of information technology solutions for the exchange of clinical data across clinical borders are to be developed and established. In the context of the Use Case Cardiology, structured patient data of the standard treatment of a patient with chronic heart failure (including treatment data already collected) are to be documented. In addition, half-yearly telephone enquiries are carried out to query hospital stays of patients with chronic heart failure. This is initially planned for a period of 3 years.

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Brief Summary in Scientific Language

The aim of the project is to establish an IT environment (MeDIC-Medical Data Integration Center) for standardised diagnostic assessment. Retrospective and prospective treatment data of patients with chronic heart failure will be systematically recorded. The aim is to identify patients who are at high risk of hospitalization due to the worsening of the chronic heart failure and/or have a poor prognosis (mortality).

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Organizational Data

  •   DRKS00015802
  •   2018/11/14
  •   [---]*
  •   yes
  •   Approved
  •   8089_BO_K_2018, Ethikkommission der Medizinischen Hochschule Hannover
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   I50.9 -  Heart failure, unspecified
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Interventions/Observational Groups

  •   Patients with chronic heart failure

    In the context of the Use Case Cardiology, structured patient data of the standard treatment of a patient with chronic heart failure (including treatment data already collected) are to be documented. In addition, half-yearly telephone enquiries are carried out to query hospital stays of patients with chronic heart failure. This is initially planned for a period of 3 years.
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Other
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

Hospitalization due to worsening of heart failure and/or all-cause mortality.

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Secondary Outcome

(1) Determination of a standard data set for patients with chronic heart failure
(2) Provision of a structured recording method for the assessment of findings
(3) Structuring and collection of retrospective and prospective care data of patients with chronic heart failure in a medical data integration Center
(4) Provision of collected care data for long-term research/development of new research questions

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
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Recruitment

  •   Actual
  •   2018/11/23
  •   6250
  •   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

(1) Age ≥ 18 years
(2) Chronic Heart Failure
(3) ability to give consent
(4) conducted patient information and presence of patient´s written declaration of consent

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Exclusion Criteria

(1) Life expectancy less than 6 months due to non-cardiological pre-existing conditions
(2) Inability to give consent

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Universitätsklinikum Heidelberg und Medizinische Fakultät der Universität Heidelberg - Health Data Science Unit
    • Mr.  Prof. Dr.  Roland  Eils 
    • Im Neuenheimer Feld 267
    • 69210  Heidelberg
    • Germany
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    • Medizinische Hochschule Hannover
    • Mr.  Prof. Dr. med.  Udo  Bavendiek 
    • Carl-Neuberg-Straße 1
    • 30625  Hannover
    • Germany
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    • Medizinische Hochschule Hannover
    • Mr.  Prof. Dr. med.  Udo  Bavendiek 
    • Carl-Neuberg-Straße 1
    • 30625  Hannover
    • Germany
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Sources of Monetary or Material Support

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    • Bundesministerium für Bildung und Forschung (BMBF) Dienstsitz Berlin
    • Kapelle-Ufer 1
    • 11055  Berlin
    • Germany
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Status

  •   Recruiting ongoing
  •   [---]*
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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.