SFB/TR19plus: Follow-up of the Cardiomyopathy Cohort SFB/TR19

• Sponsor: University Medicine Greifswald (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT02971267
• Collaborator: (none)
• Enrollment: 150
• Location: 1
• Duration (Months): 126
• Patients Per Site Per Month: 1.2

Study Details

Study Description

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	Phase
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 Design

• Study Type: Observational
• Anticipated Enrollment: 150 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Follow-up of the Inflammatory Cardiomyopathy Cohort of SFB/TR19
• Study Start Date: Jun 1, 2015
• Anticipated Primary Completion Date: Dec 1, 2022
• Anticipated Study Completion Date: Dec 1, 2025

Outcome Measures

Primary Outcome Measures

1. 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

1. 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)

2. VO2peak [1-year follow-ups up to 10 years]

   Exercise capacity by CPET (cardiopulmonary exercise testing)

3. QOL [1-year follow-ups up to 10 years]

   Quality of life by MLHF questionnaire

4. Mortality [1-year follow-ups up to 10 years]

   Mortality (HF-related, cardiovascular disease, all-cause mortality)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Participation in baseline examination of SFB/TR19

Exclusion Criteria:

• none

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Internal Medicine B, University Medicine Greifswald	Greifswald	MV	Germany	17475

Sponsors and Collaborators

• University Medicine Greifswald

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University Medicine Greifswald
• ClinicalTrials.gov Identifier: NCT02971267
• Other Study ID Numbers: SFB/TR19plus-001
• First Posted: Nov 22, 2016
• Last Update Posted: Oct 1, 2021
• Last Verified: Sep 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by University Medicine Greifswald: heart failure; cardiomyopathy; myocarditis
• Additional relevant MeSH terms: Heart Failure; Cardiomyopathies

Study Results

No Results Posted as of Oct 1, 2021