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Follow-up of the Cardiomyopathy Cohort SFB/TR19 (SFB/TR19plus)

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ClinicalTrials.gov Identifier: NCT02971267
Recruitment Status : Recruiting
First Posted : November 22, 2016
Last Update Posted : July 2, 2018
Sponsor:
Information provided by (Responsible Party):
University Medicine Greifswald

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

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

Detailed Description:
Periodical follow-up of a cohort of inflammatory cardiomyopathy patients (suspected or validated inflammatory cardiomyopathy) recruited at baseline by the SFB/TR19 project. Participants will be followed up at least every year - or more frequently based on clinical need. Standardized protocols will be used for the assessment of medical history and examinations, laboratory biomarkers, and the collection of various biomaterials for biobanking purposes.

Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Follow-up of the Inflammatory Cardiomyopathy Cohort of SFB/TR19
Study Start Date : June 2015
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cardiomyopathy


Intervention Details:
  • Other: Observational
    None, observational only


Primary Outcome Measures :
  1. Number of cardiovascular events [ Time Frame: 1-year follow-ups up to 10 years ]
    Number of hospitalization (HF based. all-cause), interventions (ICD, pacemaker), myocardial infarction


Secondary Outcome Measures :
  1. LVEF (left ventricular ejection fraction) [ Time Frame: 1-year follow-ups up to 10 years ]
    Left ventricular ejection fraction at time of follow-ups (through study completion, every year)

  2. VO2peak [ Time Frame: 1-year follow-ups up to 10 years ]
    Exercise capacity by CPET (cardiopulmonary exercise testing)

  3. QOL [ Time Frame: 1-year follow-ups up to 10 years ]
    Quality of life by MLHF questionnaire

  4. Mortality [ Time Frame: 1-year follow-ups up to 10 years ]
    Mortality (HF-related, cardiovascular disease, all-cause mortality)


Biospecimen Retention:   Samples With DNA
blood


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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:

  • Participation in baseline examination of SFB/TR19

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): NCT02971267


Contacts
Contact: Marcus Dörr, MD +49383486 ext 80500 mdoerr@uni-greifswald.de
Contact: Stephan B Felix, MD +49383486 ext 80500 felix@uni-greifswald.de

Locations
Germany
Department of Internal Medicine B, University Medicine Greifswald Recruiting
Greifswald, MV, Germany, 17475
Contact: Marcus Dörr, MD    +49383486 ext 80500    mdoerr@uni-greifswald.de   
Contact: Stephan B Felix, MD    +49383486 ext 80500    felix@uni-greifswald.de   
Sub-Investigator: Kristin Lehnert, MD         
Sub-Investigator: Sabine Kaczmarek, MD         
Sub-Investigator: Ann Louise Pedersen, MD         
Sponsors and Collaborators
University Medicine Greifswald

Responsible Party: University Medicine Greifswald
ClinicalTrials.gov Identifier: NCT02971267     History of Changes
Other Study ID Numbers: SFB/TR19plus-001
First Posted: November 22, 2016    Key Record Dates
Last Update Posted: July 2, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by University Medicine Greifswald:
heart failure
cardiomyopathy
myocarditis

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