Follow-up of GANI_MED Cardio Cohorts

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Chronic Heart Failure, Metabolic Syndrome

Intervention / Treatment
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* Other: no intervention, only observational


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participation in baseline examination of GANI_MED cohorts (heart failure, metabolic risk) Exclusion Criteria: none

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Heart Failure<br>Patients with chronic heart failure and with/without reduced left ventricular ejection fraction (EF) at baseline (HFrEF, HFmrEF, HFpEF) | Other: no intervention, only observational<br>* no intervention, only observational<br>|
| Cardiometabolic risk<br>Patients with cardiovascular diseases and metabolic risk factors at baseline | Other: no intervention, only observational<br>* no intervention, only observational<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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heart failure, heart disease, cardiovascular disease, metabolic risk, comorbidities