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Inflammatory Cardiomyopathy Baseline Cohort (SFB/TR19) (SFB/TR19)

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ClinicalTrials.gov Identifier: NCT02970227
Recruitment Status : Completed
First Posted : November 21, 2016
Last Update Posted : November 22, 2016
Sponsor:
Information provided by (Responsible Party):
University Medicine Greifswald

Brief Summary:
cohort of cardiomyopathy patients (suspected or validated inflammatory cardiomyopathy) recruited at baseline by the SFB-TR19 project. Standardized protocols used for the assessment of medical history and examinations, laboratory biomarkers, and the collection of various biosamples for biobanking purposes.

Condition or disease Intervention/treatment
Cardiomyopathies Heart Failure Other: Observation

Study Type : Observational [Patient Registry]
Actual Enrollment : 920 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 12 Years
Official Title: Inflammatory Cardiomyopathy Cohort of the SFB/TR19 [Kohorte "Entzündliche Kardiomyopathien" Des Sonderforschungsbereichs/Transregio 19 (SFB/TR19)]
Study Start Date : January 2004
Actual Primary Completion Date : June 2015
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cardiomyopathy


Intervention Details:
  • Other: Observation
    None, observation only


Primary Outcome Measures :
  1. Cardiovascular events [ Time Frame: 1-year follow-ups ]
    Hospitalization (HF based. all-cause), interventions (ICD, pacemaker), myocardial infarction


Secondary Outcome Measures :
  1. LVEF [ Time Frame: 1-year follow-ups ]
    Left ventricular ejection fraction at time of follow-up

  2. VO2peak [ Time Frame: 1-year follow-ups ]
    Exercise capacity by CPET

  3. QOL [ Time Frame: 1-year follow-ups ]
    Quality of life by questionnaire (Minnesota Living with HF questionnaire)

  4. Mortality [ Time Frame: 1-year follow-ups ]
    Mortality (HF-related, CVD, all-cause)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with suspected or validated inflammatory cardiomyopathy at baseline
Criteria

Inclusion Criteria:

  • suspected inflammatory cardiomyopathy at baseline

Exclusion Criteria:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02970227


Locations
Germany
Department of Internal Medicine B, University Medicine Greifswald
Greifswald, MV, Germany, 17475
Sponsors and Collaborators
University Medicine Greifswald

Responsible Party: University Medicine Greifswald
ClinicalTrials.gov Identifier: NCT02970227     History of Changes
Other Study ID Numbers: SFB/TR19-001
First Posted: November 21, 2016    Key Record Dates
Last Update Posted: November 22, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by University Medicine Greifswald:
heart failure
cardiomyopathies
myocarditis

Additional relevant MeSH terms:
Heart Failure
Cardiomyopathies
Heart Diseases
Cardiovascular Diseases