GANIFU-Card: Follow-up of GANI_MED Cardio Cohorts

Sponsor
University Medicine Greifswald (Other)
Overall Status
Recruiting
CT.gov ID
NCT02970214
Collaborator
(none)
1,200
1
73
16.4

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
1200 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Greifswald Approach to Individualized Medicine (GANI_MED) - Follow-up of Cardiovascular Cohorts
Study Start Date :
Nov 1, 2016
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. Cardiovascular events [1-year follow-ups]

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

Secondary Outcome Measures

  1. VO2peak [1-year follow-ups]

    Exercise capacity by CPET

  2. QOL [1-year follow-ups]

    Quality of life by questionnaire (Minnesota Living with heart failure questionnaire)

  3. 6MW [1-year follow-ups]

    6 minute walk test distance

  4. LVEF [1-year follow-ups]

    Left ventricular ejection fraction by echo at time of follow-up

Other Outcome Measures

  1. PWA [1-year follow-ups]

    pulse wave analysis parameters by Vascular Explorer device (neverdis GmbH, Germany)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Participation in baseline examination of GANI_MED cohorts (heart failure, metabolic risk)
Exclusion Criteria:
  • none

Contacts and Locations

Locations

Site City State Country Postal Code
1 Department of Internal Medicine B, University Medicine Greifswald Greifswald MV Germany 17475

Sponsors and Collaborators

  • University Medicine Greifswald

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:
University Medicine Greifswald
ClinicalTrials.gov Identifier:
NCT02970214
Other Study ID Numbers:
  • GANIFU-C-001
First Posted:
Nov 21, 2016
Last Update Posted:
Oct 1, 2021
Last Verified:
Sep 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Keywords provided by University Medicine Greifswald
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 1, 2021