Competence Network Heart Failure (KNHI)

The competence network in heart failure is a Germany wide network of physicians, scientists, self-help groups and other organizations concerned about the problem of heart disease.

The major task of the competence network is the coordination of medical research and creation of infrastructure for the standardized execution of geographically separated research projects.

In content and structure, the competence network covers the following subprojects at present:

1     Center for the competence network for heart failure (Berlin) 
2a     Computing, internet and information services (Leipzig) 
2b     Center for clinical trial coordination, trial management and Biostatistics (ZSSB, Leipzig) 
3     Center for tissue samples and bank for biological material (Berlin) 
4     Epidemiology of heart failure (Muenster) 
5     Etiology of heart failure (Luebeck, Dortmund, Regensburg) 
6     New strategies in Diagnostics: graphic procedures/serum and plasma marker (Wuerzburg) 
7     Diastolic heart insufficiency (Goettingen) 
8     Molecular mechanisms of heart insufficiency (Berlin, Hanover) 
9     Quality of life (Heidelberg) 
10      (cancelled)  
11     Study group "multi-centric clinical trials" 

The coordination center for clinical trials in Leipzig (KKS) is responsible for the competence network in heart failure on the one hand and for the computer systems and information service on the other. In the context of this sub-project the KKS is responsible for the construction of an information and a communication platform (Extranet) in order to make possible direct communication between the cooperation partners, as well as for the rapid delivery of new information to interested outside parties via Internet.

A further important task exists in the development and implementation of a core Database of networks to which the tissue sample administration databse, the peadiatric database, clinical trial database, the sepsis databse as well as the gene data base all belong. An important aspect of the conversion of the IT concept is the adherence to the safety and data security guidelines as well as the development of suitable role concepts.

In addition, KKS functions as a Center for Study co-ordination, Study management and Biometry (ZSSB German acronym) in the entire Competence network structure.

This center (ZSSB) within KKS, functions to create a suitable infrastructure primarily for the execution of clinical trials at a qualitatively high level. In order to reach this goal, clinical trials are planned by the ZSSB within the structure of the competence networks, and are executed and evaluated inside of this framework. Concretely, this procedure needs to possess the support of the co-operation partners in both the production of clinical trial protocols and with the selection of the biometric design. Furthermore, the ZSSB estimates the sample size for clinical studies and supports CRF and SOP creation. Likewise, the ZSSB undertakes the task of randomisation of the study population including the recruiting monitoring . Further tasks exist in the active data management and monitoring of the trials as well as the biostatistic interim and final evaluations including a written report. A harmonization of the contents of all of the documentation for each clinical trial in the comptence network is necessary for this process, as well as the development of a data dictionary under the supervision of the ZSSB.

 

Contact:

Project Coordination: Dr. rer. nat. Christiane Prettin 
Phone: +49 341 97 16273
Fax: +49 341 97 16289
E-Mail: e-mail address

 

Biometry: Dr. rer. med. Dr. rer. nat. Götz Gelbrich
Phone: +49 341 97 16270
Fax: +49 341 97 16259
E-Mail: e-mail address

 

Last updated: 27-Aug-2009