Clinical trial NCT02970214: Follow-up of GANI_MED Cardio Cohorts
Official title: Greifswald Approach to Individualized Medicine (GANI_MED) - Follow-up of Cardiovascular Cohorts
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chronic Heart Failure
Metabolic Syndrome
Keywords: heart failure
heart disease
cardiovascular disease
metabolic risk
comorbidities
Lead sponsor: University Medicine Greifswald
Sponsor class: OTHER
First posted: 2016-11-21
Enrollment: 1200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients included into the baseline examinations of the two cohorts

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* Participation in baseline examination of GANI_MED cohorts (heart failure, metabolic risk)

Exclusion Criteria:

* none

Primary outcomes:
measure: Cardiovascular events
timeFrame: 1-year follow-ups
Secondary outcomes:
measure: VO2peak
timeFrame: 1-year follow-ups
measure: QOL
timeFrame: 1-year follow-ups
measure: 6MW
timeFrame: 1-year follow-ups
measure: LVEF
timeFrame: 1-year follow-ups
Other outcomes:
measure: PWA
timeFrame: 1-year follow-ups
Locations:
city: Greifswald
country: Germany
facility: Department of Internal Medicine B, University Medicine Greifswald
state: MV
Study officials:
References:
citation: 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.