Follow-up of GANI_MED Cardio Cohorts

NCT02970214 | Unknown

• 1 other identifier: GANIFU-C-001
• Study Type: observational
• Target: 1,200
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Heart Failure; Metabolic Syndrome

Keywords

heart failure; heart disease; cardiovascular disease; metabolic risk; comorbidities

Outcome Measures

Primary Outcomes (1)

• Cardiovascular events

  Hospitalization (HF based. all-cause), myocardial infarction

  1-year follow-ups

Secondary Outcomes (4)

• VO2peak

  1-year follow-ups

• QOL

  1-year follow-ups

• 6MW

  1-year follow-ups

• LVEF

  1-year follow-ups

Other Outcomes (1)

• PWA

  1-year follow-ups

Study Arms (2)

Heart Failure

Patients with chronic heart failure and with/without reduced left ventricular ejection fraction (EF) at baseline (HFrEF, HFmrEF, HFpEF)

Other: no intervention, only observational

Cardiometabolic risk

Patients with cardiovascular diseases and metabolic risk factors at baseline

Other: no intervention, only observational

Interventions

no intervention, only observational OTHER

no intervention, only observational

Cardiometabolic risk; Heart Failure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients included into the baseline examinations of the two cohorts

You may qualify if:

• Participation in baseline examination of GANI\_MED cohorts (heart failure, metabolic risk)

You may not qualify if:

• none

Sponsors & Collaborators

• University Medicine Greifswald: lead

Study Sites (1)

Department of Internal Medicine B, University Medicine Greifswald

Greifswald, Mecklenburg-Vorpommern, 17475, Germany

RECRUITING

Related 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.

  PMID: 24886498 BACKGROUND

Related Links

• Homepage of GANI\_MED project

Biospecimen

Retention: SAMPLES WITH DNA

blood, urine

MeSH Terms

Conditions

Metabolic Syndrome; Heart Failure; Heart Diseases; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Central Study Contacts

Marcus Dörr, MD

CONTACT

+49383486; mdoerr@uni-greifswald.de

Stephan B Felix, MD

CONTACT

+49383486; felix@uni-greifswald.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2016
• First Posted: November 21, 2016
• Study Start: November 1, 2016
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: December 12, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)