Inflammatory Cardiomyopathy Baseline Cohort (SFB/TR19)

Heart Failure Clinical Trial

— SFB/TR19  

Official title:

Inflammatory Cardiomyopathy Cohort of the SFB/TR19 [Kohorte "Entzündliche Kardiomyopathien" Des Sonderforschungsbereichs/Transregio 19 (SFB/TR19)]

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02970227
• Other study ID #: SFB/TR19-001
• Status: Completed
• Phase: N/A
• First received: November 9, 2016
• Last updated: November 21, 2016
• Start date: January 2004
• Est. completion date: June 2015

Study information

• Verified date: November 2016
• Source: University Medicine Greifswald
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 920
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• suspected inflammatory cardiomyopathy at baseline

Exclusion Criteria:

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cardiomyopathies
• Heart Failure

Intervention

Other:
• Observation
None, observation 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	Cardiovascular events	Hospitalization (HF based. all-cause), interventions (ICD, pacemaker), myocardial infarction	1-year follow-ups	No
Secondary	LVEF	Left ventricular ejection fraction at time of follow-up	1-year follow-ups	No
Secondary	VO2peak	Exercise capacity by CPET	1-year follow-ups	No
Secondary	QOL	Quality of life by questionnaire (Minnesota Living with HF questionnaire)	1-year follow-ups	No
Secondary	Mortality	Mortality (HF-related, CVD, all-cause)	1-year follow-ups	No