CardiomyopathiesSFB/TR19NCT02970227
Inflammatory Cardiomyopathy Baseline Cohort (SFB/TR19)
An observational study of Cardiomyopathies and Heart Failure, run by University Medicine Greifswald at 1 site in Germany.
Trial 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. 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?
- Observation
- How many people
- 920 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2004to Jun 2015
- How long will I take part?
- 12 Years
- 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
- suspected inflammatory cardiomyopathy at baseline
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Internal Medicine B, University Medicine Greifswald
Greifswald, Mecklenburg-Vorpommern, 17475
About this study
Official title: Inflammatory Cardiomyopathy Cohort of the SFB/TR19 [Kohorte "Entzündliche Kardiomyopathien" Des Sonderforschungsbereichs/Transregio 19 (SFB/TR19)]
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.
- Conditions
- Cardiomyopathies, Heart Failure
- Being tested
- Observation
- Keywords
- heart failure, cardiomyopathies, 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.
ObservationOther
None, observation only
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiovascular events
Hospitalization (HF based. all-cause), interventions (ICD, pacemaker), myocardial infarction
Measured: 1-year follow-ups
Secondary outcomes (4)
LVEF
Left ventricular ejection fraction at time of follow-up
Measured: 1-year follow-ups
VO2peak
Exercise capacity by CPET
Measured: 1-year follow-ups
QOL
Quality of life by questionnaire (Minnesota Living with HF questionnaire)
Measured: 1-year follow-ups
Mortality
Mortality (HF-related, CVD, all-cause)
Measured: 1-year follow-ups
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2016 (estimated)
- Study startJan 2004
- Primary completionJun 2015
- Study completionJun 2015
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
- 920 participants (actual)
- Target duration
- 12 Years
Sponsor and investigators
- Lead sponsor
- University Medicine Greifswald
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02970227
- Sponsor's protocol ID
- SFB/TR19-001
- Acronym
- SFB/TR19
- Status last verified
- Nov 2016
- First submitted
- 9 Nov 2016
- Last updated
- 22 Nov 2016
- 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 22 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inflammatory Cardiomyopathy Cohort of the SFB/TR19 [Kohorte "Entzündliche Kardiomyopathien" Des Sonderforschungsbereichs/Transregio 19 (SFB/TR19)]
- ClinicalTrials.gov ID
- NCT02970227
- Acronym / sponsor ID
- SFB/TR19 / SFB/TR19-001
- Conditions
- Cardiomyopathies, Heart Failure
- Keywords
- heart failure, cardiomyopathies, myocarditis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 920 participants (actual)
- Lead sponsor
- University Medicine GreifswaldUniversity, hospital or other
- Study start
- Jan 2004
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 21 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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Years
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)
- suspected inflammatory cardiomyopathy at baseline
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 |
|---|---|---|
| ObservationNone, observation only | Other | – |
Primary outcome
Cardiovascular events
Time frame: 1-year follow-ups
Hospitalization (HF based. all-cause), interventions (ICD, pacemaker), myocardial infarction
4 secondary outcomes
LVEF
Time frame: 1-year follow-ups
VO2peak
Time frame: 1-year follow-ups
QOL
Time frame: 1-year follow-ups
Mortality
Time frame: 1-year follow-ups
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2016.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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: finished, as of the sponsor's last update on 22 Nov 2016. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiovascular events (time frame: 1-year follow-ups). 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 22 Nov 2016.