Follow-up of GANI_MED Cardio Cohorts (GANIFU-Card)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Metabolic Syndrome; Chronic Heart Failure
• Intervention / Treatment: Other: no intervention, only observational

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.

• Study Type: Observational
• Enrollment (Estimated): 1200

Contacts and Locations

• Study Contact: Name: Marcus Dörr, MD; Phone Number: 80500 +49383486; Email: mdoerr@uni-greifswald.de
• Study Contact Backup: Name: Stephan B Felix, MD; Phone Number: 80500 +49383486; Email: felix@uni-greifswald.de

Study Locations

• Germany
  • MV
    • Greifswald, MV, Germany, 17475
      • Recruiting
      • Department of Internal Medicine B, University Medicine Greifswald
      • Contact: Marcus Dörr, MD; Phone Number: 80500 +49383486; Email: mdoerr@uni-greifswald.de
      • Contact: Stephan B Felix, MD; Phone Number: 80500 +49383486; Email: felix@uni-greifswald.de
      • Sub-Investigator: Kristin Lehnert, MD
      • Sub-Investigator: Sabine Kaczmarek, MD
      • Sub-Investigator: Ann Lousie Pedersen, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

All patients included into the baseline examinations of the two cohorts

Description

Inclusion Criteria:

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

Exclusion Criteria:

• none

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; no intervention, only observational
Cardiometabolic risk; Patients with cardiovascular diseases and metabolic risk factors at baseline	Other: no intervention, only observational; no intervention, only observational

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cardiovascular events	Hospitalization (HF based. all-cause), myocardial infarction	1-year follow-ups

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
VO2peak	Exercise capacity by CPET	1-year follow-ups
QOL	Quality of life by questionnaire (Minnesota Living with heart failure questionnaire)	1-year follow-ups
6MW	6 minute walk test distance	1-year follow-ups
LVEF	Left ventricular ejection fraction by echo at time of follow-up	1-year follow-ups

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
PWA	pulse wave analysis parameters by Vascular Explorer device (neverdis GmbH, Germany)	1-year follow-ups

Collaborators and Investigators

• Sponsor: University Medicine Greifswald

Publications and helpful links

General Publications

• 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.

Helpful Links

• Homepage of GANI_MED project

Study record dates

Study Major Dates

• Study Start: November 1, 2016
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: November 9, 2016
• First Submitted That Met QC Criteria: November 17, 2016
• First Posted (Estimated): November 21, 2016

Study Record Updates

• Last Update Posted (Estimated): December 12, 2023
• Last Update Submitted That Met QC Criteria: December 11, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: comorbidities; cardiovascular disease; heart failure; metabolic risk; heart disease
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Insulin Resistance; Hyperinsulinism; Heart Failure; Metabolic Syndrome
• Other Study ID Numbers: GANIFU-C-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO