Inflammatory Cardiomyopathy Baseline Cohort (SFB/TR19)
Sponsor
University Medicine Greifswald (Other)
Overall Status
Completed
CT.gov ID
NCT02970227
Collaborator
(none)
920
1
137
6.7
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Study Type:
Observational [Patient Registry]
Actual Enrollment
:
920 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Inflammatory Cardiomyopathy Cohort of the SFB/TR19 [Kohorte "Entzündliche Kardiomyopathien" Des Sonderforschungsbereichs/Transregio 19 (SFB/TR19)]
Study Start Date
:
Jan 1, 2004
Actual Primary Completion Date
:
Jun 1, 2015
Actual Study Completion Date
:
Jun 1, 2015
Outcome Measures
Primary Outcome Measures
- Cardiovascular events [1-year follow-ups]
Hospitalization (HF based. all-cause), interventions (ICD, pacemaker), myocardial infarction
Secondary Outcome Measures
- LVEF [1-year follow-ups]
Left ventricular ejection fraction at time of follow-up
- VO2peak [1-year follow-ups]
Exercise capacity by CPET
- QOL [1-year follow-ups]
Quality of life by questionnaire (Minnesota Living with HF questionnaire)
- Mortality [1-year follow-ups]
Mortality (HF-related, CVD, all-cause)
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
- suspected inflammatory cardiomyopathy at baseline
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:
NCT02970227
Other Study ID Numbers:
- SFB/TR19-001
First Posted:
Nov 21, 2016
Last Update Posted:
Nov 22, 2016
Last Verified:
Nov 1, 2016
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Keywords provided by University Medicine Greifswald
Additional relevant MeSH terms: