Follow-up of GANI_MED Cardio Cohorts
- Conditions
- Metabolic SyndromeChronic Heart Failure
- Interventions
- Other: no intervention, only observational
- Registration Number
- NCT02970214
- Lead Sponsor
- University Medicine Greifswald
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 1200
- Participation in baseline examination of GANI_MED cohorts (heart failure, metabolic risk)
- none
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Cardiometabolic risk no intervention, only observational Patients with cardiovascular diseases and metabolic risk factors at baseline Heart Failure no intervention, only observational Patients with chronic heart failure and with/without reduced left ventricular ejection fraction (EF) at baseline (HFrEF, HFmrEF, HFpEF)
- Primary Outcome Measures
Name Time Method Cardiovascular events 1-year follow-ups Hospitalization (HF based. all-cause), myocardial infarction
- Secondary Outcome Measures
Name Time Method 6MW 1-year follow-ups 6 minute walk test distance
QOL 1-year follow-ups Quality of life by questionnaire (Minnesota Living with heart failure questionnaire)
VO2peak 1-year follow-ups Exercise capacity by CPET
LVEF 1-year follow-ups Left ventricular ejection fraction by echo at time of follow-up
Trial Locations
- Locations (1)
Department of Internal Medicine B, University Medicine Greifswald
🇩🇪Greifswald, MV, Germany