Systolic Dysfunction, Transition, Heart Failure, BiobankTransitionCHFNCT02323750
TransitionCHF Systolic Dysfunction to Congestive Heart Failure Cohort Study
An observational study of Systolic Dysfunction, Transition, Heart Failure, Biobank, run by University of Göttingen at 1 site in Germany.
Trial summary
TransitionCHF aims to recruit a unique cohort of patients with asymptomatic left ventricular dysfunction (NYHA I) to study the progression to symptomatic (>NYHA I) HF and to identify parameters/ biomarkers promoting and predicting the individual risk of transition. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Systolic Dysfunction, Transition, Heart Failure, Biobank
- How many people
- 1,000 participants
- Where
- 1 siteGermany
- Study dates
- 1 Dec 2014to 31 Dec 2027
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: The DZHK TransitionCHF Cohort Study will include patients with systolic dysfunction (NYHA I), i.e. (1) patients without a history of HF symptoms and (2) patients who reversed from symptomatic HF. Patients will be recruited prospectively at the participating DZHK centres, non-DZHK university hospitals and centers.
Who may be able to join
- Asymptomatic systolic dysfunction (defined as: ejection fraction < 40% by echocardiography or MRI; documented within the last 3 months prior to baseline visit)
- A maximum of one hospitalization for heart failure (defined as hospitalization with signs and symptoms of heart failure requiring intravenous loop diuretic therapy within 48 hours after hospital admission) at least 2 years prior to the baseline visit
- No heart failure symptoms (NYHA II, III or IV) upon inclusion
- 6MWD ≥ 80% of reference values
- Written informed consent
- Age ≥ 18 years
Who cannot join
- Symptomatic heart failure (NYHA>I) at baseline visit
- Any significant valvular disease (> 2nd degree)
- Severe pulmonary disease (e.g. FEV1/FVC <0.7 and FEV1<50%)
- Severe renal disease (GFR < 15 ml/min)
- ejection fraction at baseline visit ≥ 50% by echocardiography or MRI
- Life expectancy < 1 year
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- Pericardial disease
- Hypertrophic cardiomyopathy
- Myocardial infarction within the last 3 months
- Planned cardiac surgical intervention within 3 months after inclusion
- Geographical reasons (e. g. patients living outside Germany or planning to move abroad)
- Inability to give informed consent (e. g. mental disorders)
- Therapy with loop diuretics (e.g. torasemide, furosemide, piretanide) within 4 weeks prior to inclusion/baseline visit
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Systolic Dysfunction to Congestive Heart Failure Cohort Study
TransitionCHF aims to recruit a unique cohort of patients with asymptomatic left ventricular dysfunction (NYHA I) to study the progression to symptomatic (>NYHA I) HF and to identify parameters/ biomarkers promoting and predicting the individual risk of transition. Results from TransitionCHF Cohort Study will inform and refine current treatment guidelines. The implementation of common patient data sets and biobanking standards will enable data and biomaterial sharing with other study groups of the German Center for Cardiovascular Research (DZHK). This study will set the standard for a unique DZHK heart failure database and Biobank for innovative preclinical and clinical trials.
- Medical subject headings
- Heart Failure
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite endpoint of hospitalization for heart failure and cardiovascular death
Measured: 0.5 - 13 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2014 (estimated)
- Study start1 Dec 2014
- Primary completion30 Sep 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systolic Dysfunction, Transition, Heart Failure, BiobankStudies 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
- 1,000 participants (actual)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- University of Göttingen
- Sponsor type
- University, hospital or other
- Collaborators
- University Medical Center Goettingen, Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)
- Responsible party
- Principal investigator, Gerd Hasenfus, University of Göttingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02323750
- Sponsor's protocol ID
- TransitionCHF
- Acronym
- TransitionCHF
- Status last verified
- Nov 2023
- First submitted
- 18 Dec 2014
- Last updated
- 22 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Systolic Dysfunction to Congestive Heart Failure Cohort Study
- ClinicalTrials.gov ID
- NCT02323750
- Acronym / sponsor ID
- TransitionCHF / TransitionCHF
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- University of GöttingenUniversity, hospital or other
- Collaborators
- University Medical Center Goettingen, Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)
- Study start
- 1 Dec 2014 (actual)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 23 Dec 2014 (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.
TransitionCHF aims to recruit a unique cohort of patients with asymptomatic left ventricular dysfunction (NYHA I) to study the progression to symptomatic (>NYHA I) HF and to identify parameters/ biomarkers promoting and predicting the individual risk of transition. Results from TransitionCHF Cohort Study will inform and refine current treatment guidelines. The implementation of common patient data sets and biobanking standards will enable data and biomaterial sharing with other study groups of the German Center for Cardiovascular Research (DZHK). This study will set the standard for a unique DZHK heart failure database and Biobank for innovative preclinical and clinical trials.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The DZHK TransitionCHF Cohort Study will include patients with systolic dysfunction (NYHA I), i.e. (1) patients without a history of HF symptoms and (2) patients who reversed from symptomatic HF. Patients will be recruited prospectively at the participating DZHK centres, non-DZHK university hospitals and centers.
Key inclusion criteria (6 listed)
- Asymptomatic systolic dysfunction (defined as: ejection fraction < 40% by echocardiography or MRI; documented within the last 3 months prior to baseline visit)
- A maximum of one hospitalization for heart failure (defined as hospitalization with signs and symptoms of heart failure requiring intravenous loop diuretic therapy within 48 hours after hospital admission) at least 2 years prior to the baseline visit
- No heart failure symptoms (NYHA II, III or IV) upon inclusion
- 6MWD ≥ 80% of reference values
- Written informed consent
Key exclusion criteria (13 listed)
- Symptomatic heart failure (NYHA>I) at baseline visit
- Any significant valvular disease (> 2nd degree)
- Severe pulmonary disease (e.g. FEV1/FVC <0.7 and FEV1<50%)
- Severe renal disease (GFR < 15 ml/min)
- ejection fraction at baseline visit ≥ 50% by echocardiography or MRI
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Composite endpoint of hospitalization for heart failure and cardiovascular death
Time frame: 0.5 - 13 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2023.
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 Systolic Dysfunction, Transition, Heart Failure, Biobank, run by University of Göttingen 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 6 inclusion and 13 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: under way, not looking for participants, as of the sponsor's last update on 22 Nov 2023. 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?
This study is still under way. Results are not available in the source record yet.
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?
Composite endpoint of hospitalization for heart failure and cardiovascular death (time frame: 0.5 - 13 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 22 Nov 2023.