Follow-up of GANI_MED Cardio Cohorts

NCT ID: NCT02970214

Last Updated: 2023-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-11-30

Study Completion Date

2024-12-31

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.

Conditions

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Chronic Heart Failure Metabolic Syndrome

Keywords

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heart failure heart disease cardiovascular disease metabolic risk comorbidities

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Heart Failure

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

no intervention, only observational

Intervention Type OTHER

no intervention, only observational

Cardiometabolic risk

Patients with cardiovascular diseases and metabolic risk factors at baseline

no intervention, only observational

Intervention Type OTHER

no intervention, only observational

Interventions

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no intervention, only observational

no intervention, only observational

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* none
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Medicine Greifswald

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Department of Internal Medicine B, University Medicine Greifswald

Greifswald, Mecklenburg-Vorpommern, Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Marcus Dörr, MD

Role: CONTACT

Phone: +49383486

Email: [email protected]

Stephan B Felix, MD

Role: CONTACT

Phone: +49383486

Email: [email protected]

Facility Contacts

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Marcus Dörr, MD

Role: primary

Stephan B Felix, MD

Role: backup

References

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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.

Reference Type BACKGROUND
PMID: 24886498 (View on PubMed)

Related Links

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Other Identifiers

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GANIFU-C-001

Identifier Type: -

Identifier Source: org_study_id