NCT02971267

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2015

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

November 9, 2016

Completed
13 days until next milestone

First Posted

Study publicly available on registry

November 22, 2016

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

October 1, 2021

Status Verified

September 1, 2021

Enrollment Period

7.5 years

First QC Date

November 9, 2016

Last Update Submit

September 30, 2021

Conditions

CardiomyopathiesHeart Failure

Keywords

heart failurecardiomyopathymyocarditis

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • LVEF (left ventricular ejection fraction)

    1-year follow-ups up to 10 years

  • VO2peak

    1-year follow-ups up to 10 years

  • QOL

    1-year follow-ups up to 10 years

  • Mortality

    1-year follow-ups up to 10 years

Interventions

ObservationalOTHER

None, observational only

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with suspected or validated inflammatory cardiomyopathy at baseline

You may qualify if:

  • Participation in baseline examination of SFB/TR19

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Internal Medicine B, University Medicine Greifswald

Greifswald, Mecklenburg-Vorpommern, 17475, Germany

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

blood

MeSH Terms

Conditions

CardiomyopathiesHeart FailureMyocarditis

Interventions

Watchful Waiting

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health CareOutcome and Process Assessment, Health CareQuality of Health CareHealth Services Administration

Central Study Contacts

Marcus Dörr, MD

CONTACT

+49383486mdoerr@uni-greifswald.de

Stephan B Felix, MD

CONTACT

+49383486felix@uni-greifswald.de

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 9, 2016

First Posted

November 22, 2016

Study Start

June 1, 2015

Primary Completion

December 1, 2022

Study Completion

December 1, 2025

Last Updated

October 1, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)