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NCT02970214 Clinical Trial

Follow-up of GANI_MED Cardio Cohorts

Metabolic Syndrome Clinical Trial

— GANIFU-Card  

Official title:
Greifswald Approach to Individualized Medicine (GANI_MED) - Follow-up of Cardiovascular Cohorts

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02970214
Other study ID # GANIFU-C-001
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date November 2016
Est. completion date December 2024

Study information
Verified date December 2023
Source University Medicine Greifswald
Contact Marcus Dörr, MD
Phone +49383486
Email mdoerr@uni-greifswald.de
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

Follow-up of two hospital-based patient cohorts (heart failure, metabolic comorbidities in CVD), recruited at baseline by the GANI_MED-project (Greifswald Approach to Individualized Medicine). Standardized protocols will be used for the assessment of medical history, laboratory biomarkers, and the collection of various biosamples for bio-banking purposes. Comparisons with the general background population will be performed.

Description:

5-year follow-up of two hospital-based patient cohorts (heart failure, metabolic comorbidities in CVD), recruited at baseline by the GANI_MED-project (Greifswald Approach to Individualized Medicine). Subjects will be comprehensively phenotypes using standardized protocols for the assessment of medical history, laboratory biomarkers, and the collection of various biosamples for bio-banking purposes. A multi-omics based biomarker assessment including genome-wide genotyping, transcriptome, metabolome, and proteome analyses complements the multi-level approach of GANI_MED. Comparisons with the general background population as characterized by the Study of Health in Pomerania (SHIP) will be performed.

Recruitment information / eligibility
Status Recruiting
Enrollment 1200
Est. completion date December 2024
Est. primary completion date December 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Participation in baseline examination of GANI_MED cohorts (heart failure, metabolic risk) Exclusion Criteria: - none

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• no intervention, only observational
no intervention, only observational

Locations
Country Name City State
Germany Department of Internal Medicine B, University Medicine Greifswald Greifswald MV

Sponsors (1)
Lead Sponsor Collaborator
University Medicine Greifswald

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Grabe HJ, Assel H, Bahls T, Dorr M, Endlich K, Endlich N, Erdmann P, Ewert R, Felix SB, Fiene B, Fischer T, Flessa S, Friedrich N, Gadebusch-Bondio M, Salazar MG, Hammer E, Haring R, Havemann C, Hecker M, Hoffmann W, Holtfreter B, Kacprowski T, Klein K, Kocher T, Kock H, Krafczyk J, Kuhn J, Langanke M, Lendeckel U, Lerch MM, Lieb W, Lorbeer R, Mayerle J, Meissner K, zu Schwabedissen HM, Nauck M, Ott K, Rathmann W, Rettig R, Richardt C, Salje K, Schminke U, Schulz A, Schwab M, Siegmund W, Stracke S, Suhre K, Ueffing M, Ungerer S, Volker U, Volzke H, Wallaschofski H, Werner V, Zygmunt MT, Kroemer HK. Cohort profile: Greifswald approach to individualized medicine (GANI_MED). J Transl Med. 2014 May 23;12:144. doi: 10.1186/1479-5876-12-144. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Other PWA pulse wave analysis parameters by Vascular Explorer device (neverdis GmbH, Germany) 1-year follow-ups
Primary Cardiovascular events Hospitalization (HF based. all-cause), myocardial infarction 1-year follow-ups
Secondary VO2peak Exercise capacity by CPET 1-year follow-ups
Secondary QOL Quality of life by questionnaire (Minnesota Living with heart failure questionnaire) 1-year follow-ups
Secondary 6MW 6 minute walk test distance 1-year follow-ups
Secondary LVEF Left ventricular ejection fraction by echo at time of follow-up 1-year follow-ups
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