NCT02970227

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
920

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2004

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

January 1, 2004

Completed
11.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

November 9, 2016

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 21, 2016

Completed
Last Updated

November 22, 2016

Status Verified

November 1, 2016

Enrollment Period

11.4 years

First QC Date

November 9, 2016

Last Update Submit

November 21, 2016

Conditions

CardiomyopathiesHeart Failure

Keywords

heart failurecardiomyopathiesmyocarditis

Outcome Measures

Primary Outcomes (1)

  • Cardiovascular events

    Hospitalization (HF based. all-cause), interventions (ICD, pacemaker), myocardial infarction

    1-year follow-ups

Secondary Outcomes (4)

  • LVEF

    1-year follow-ups

  • VO2peak

    1-year follow-ups

  • QOL

    1-year follow-ups

  • Mortality

    1-year follow-ups

Interventions

ObservationOTHER

None, observation 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:

  • suspected inflammatory cardiomyopathy at baseline

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

Location

MeSH Terms

Conditions

CardiomyopathiesHeart FailureMyocarditis

Interventions

Observation

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
12 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 9, 2016

First Posted

November 21, 2016

Study Start

January 1, 2004

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

November 22, 2016

Record last verified: 2016-11

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)