CardiomyopathiesSFB/TR19plusNCT02971267
Follow-up of the Cardiomyopathy Cohort SFB/TR19
An observational study of Cardiomyopathies and Heart Failure, run by University Medicine Greifswald at 1 site in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiomyopathies, Heart Failure
- What is being tested?
- Observational
- How many people
- 150 participants
- Where
- 1 siteGermany
- Study dates
- Jun 2015to Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with suspected or validated inflammatory cardiomyopathy at baseline
Who may be able to join
- Participation in baseline examination of SFB/TR19
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Department of Internal Medicine B, University Medicine Greifswald
Greifswald, Mecklenburg-Vorpommern, 17475
Marcus Dörr, MD, +49383486 ext. 80500, mdoerr@uni-greifswald.de
Stephan B Felix, MD, +49383486 ext. 80500, felix@uni-greifswald.de
About this study
Official title: 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.
Read the 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.
- Conditions
- Cardiomyopathies, Heart Failure
- Being tested
- Observational
- Keywords
- heart failure, cardiomyopathy, myocarditis
- Medical subject headings
- Cardiomyopathies, Heart Failure, Myocarditis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationalOther
None, observational only
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of cardiovascular events
Number of hospitalization (HF based. all-cause), interventions (ICD, pacemaker), myocardial infarction
Measured: 1-year follow-ups up to 10 years
Secondary outcomes (4)
LVEF (left ventricular ejection fraction)
Left ventricular ejection fraction at time of follow-ups (through study completion, every year)
Measured: 1-year follow-ups up to 10 years
VO2peak
Exercise capacity by CPET (cardiopulmonary exercise testing)
Measured: 1-year follow-ups up to 10 years
QOL
Quality of life by MLHF questionnaire
Measured: 1-year follow-ups up to 10 years
Mortality
Mortality (HF-related, cardiovascular disease, all-cause mortality)
Measured: 1-year follow-ups up to 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2016 (estimated)
- Study startJun 2015
- Primary completionDec 2022 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CardiomyopathiesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medicine Greifswald
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02971267
- Sponsor's protocol ID
- SFB/TR19plus-001
- Acronym
- SFB/TR19plus
- Status last verified
- Sep 2021
- First submitted
- 9 Nov 2016
- Last updated
- 1 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Follow-up of the Inflammatory Cardiomyopathy Cohort of SFB/TR19
- ClinicalTrials.gov ID
- NCT02971267
- Acronym / sponsor ID
- SFB/TR19plus / SFB/TR19plus-001
- Conditions
- Cardiomyopathies, Heart Failure
- Keywords
- heart failure, cardiomyopathy, myocarditis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University Medicine GreifswaldUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 22 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with suspected or validated inflammatory cardiomyopathy at baseline
Key inclusion criteria (1 listed)
- Participation in baseline examination of SFB/TR19
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ObservationalNone, observational only | Other | – |
Primary outcome
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
4 secondary outcomes
LVEF (left ventricular ejection fraction)
Time frame: 1-year follow-ups up to 10 years
VO2peak
Time frame: 1-year follow-ups up to 10 years
QOL
Time frame: 1-year follow-ups up to 10 years
Mortality
Time frame: 1-year follow-ups up to 10 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiomyopathies and Heart Failure, run by University Medicine Greifswald at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marcus Dörr, MD (+49383486 ext. 80500, mdoerr@uni-greifswald.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of cardiovascular events (time frame: 1-year follow-ups up to 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2021.