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

September 30, 2021 updated by: University Medicine Greifswald

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Marcus Dörr, MD
Phone Number: 80500 +49383486
Email: mdoerr@uni-greifswald.de

Study Contact Backup

Name: Stephan B Felix, MD
Phone Number: 80500 +49383486
Email: felix@uni-greifswald.de

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with suspected or validated inflammatory cardiomyopathy at baseline

Description

Inclusion Criteria:

Participation in baseline examination of SFB/TR19

Exclusion Criteria:

none

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	1-year follow-ups up to 10 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	1-year follow-ups up to 10 years
VO2peak Time Frame: 1-year follow-ups up to 10 years	Exercise capacity by CPET (cardiopulmonary exercise testing)	1-year follow-ups up to 10 years
QOL Time Frame: 1-year follow-ups up to 10 years	Quality of life by MLHF questionnaire	1-year follow-ups up to 10 years
Mortality Time Frame: 1-year follow-ups up to 10 years	Mortality (HF-related, cardiovascular disease, all-cause mortality)	1-year follow-ups up to 10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Medicine Greifswald

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2015

Primary Completion (Anticipated)

December 1, 2022

Study Completion (Anticipated)

December 1, 2025

Study Registration Dates

First Submitted

November 9, 2016

First Submitted That Met QC Criteria

November 19, 2016

First Posted (Estimate)

November 22, 2016

Study Record Updates

Last Update Posted (Actual)

October 1, 2021

Last Update Submitted That Met QC Criteria

September 30, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

SFB/TR19plus-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.