Follow-up of the Cardiomyopathy Cohort SFB/TR19

Recruiting

• Conditions: Cardiomyopathies; Heart Failure

• Registration Number: NCT02971267
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2015-06
• Study First Submitted: 2016-11-09
• Study First Submitted QC: 2016-11-19
• Study First Posted: 2016-11-22
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-30
• Last Update Posted: 2021-10-01
• Primary Completion: 2022-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• Participation in baseline examination of SFB/TR19

Exclusion Criteria

• none

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of cardiovascular events	1-year follow-ups up to 10 years	Number of hospitalization (HF based. all-cause), interventions (ICD, pacemaker), myocardial infarction

Secondary Outcome Measures

Name	Time	Method
VO2peak	1-year follow-ups up to 10 years	Exercise capacity by CPET (cardiopulmonary exercise testing)
Mortality	1-year follow-ups up to 10 years	Mortality (HF-related, cardiovascular disease, all-cause mortality)
LVEF (left ventricular ejection fraction)	1-year follow-ups up to 10 years	Left ventricular ejection fraction at time of follow-ups (through study completion, every year)
QOL	1-year follow-ups up to 10 years	Quality of life by MLHF questionnaire

Trial Locations

Locations (1)

Department of Internal Medicine B, University Medicine Greifswald; 🇩🇪 Greifswald, MV, Germany