Follow-up of the Cardiomyopathy Cohort SFB/TR19

Heart Failure Clinical Trial

— SFB/TR19plus  

Official title:

Follow-up of the Inflammatory Cardiomyopathy Cohort of SFB/TR19

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02971267
• Other study ID #: SFB/TR19plus-001
• Status: Recruiting
• Start date: June 2015
• Est. completion date: December 2025

Study information

• Verified date: September 2021
• Source: University Medicine Greifswald
• Contact: Marcus Dörr, MD
• Phone: +49383486
• Email: mdoerr[@]uni-greifswald.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 2025
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Participation in baseline examination of SFB/TR19

Exclusion Criteria:

• none

Related Conditions & MeSH terms

• Cardiomyopathies
• Heart Failure

Intervention

Other:
• Observational
None, observational only

Locations

Country	Name	City	State
Germany	Department of Internal Medicine B, University Medicine Greifswald	Greifswald	MV

Sponsors (1)

Lead Sponsor	Collaborator
University Medicine Greifswald

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of cardiovascular events	Number of hospitalization (HF based. all-cause), interventions (ICD, pacemaker), myocardial infarction	1-year follow-ups up to 10 years
Secondary	LVEF (left ventricular ejection fraction)	Left ventricular ejection fraction at time of follow-ups (through study completion, every year)	1-year follow-ups up to 10 years
Secondary	VO2peak	Exercise capacity by CPET (cardiopulmonary exercise testing)	1-year follow-ups up to 10 years
Secondary	QOL	Quality of life by MLHF questionnaire	1-year follow-ups up to 10 years
Secondary	Mortality	Mortality (HF-related, cardiovascular disease, all-cause mortality)	1-year follow-ups up to 10 years