NCT02323750Active, not recruiting
TransitionCHF Systolic Dysfunction to Congestive Heart Failure Cohort Study
Systolic Dysfunction to Congestive Heart Failure Cohort Study
Source: ClinicalTrials.gov · Last updated 22 Nov 2023
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 1000 (actual)
- First submitted
- 18 Dec 2014
- Start date
- 1 Dec 2014
- Primary completion date
- 30 Sept 2027
- Lead sponsor
- University of Göttingen
- Diseases
- Heart failure
- NCT number
- NCT02323750
What you commit to
- Study type: Observational
- Participants enrolled: 1000
- From 1 Dec 2014 to the primary completion date, 30 Sept 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Therapy with loop diuretics (e.g. torasemide, furosemide, piretanide) within 4 weeks prior to inclusion/baseline visit
Other illness
- 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%)
- Pericardial disease
- Myocardial infarction within the last 3 months
- Planned cardiac surgical intervention within 3 months after inclusion
- Inability to give informed consent (e. g. mental disorders)
Lab values
- Severe renal disease (GFR \< 15 ml/min)
- ejection fraction at baseline visit ≥ 50% by echocardiography or MRI
Other
- Life expectancy \< 1 year
- Hypertrophic cardiomyopathy
- Geographical reasons (e. g. patients living outside Germany or planning to move abroad)
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Medical Center Goettingen Coordinator of this site? Confirm its status | Göttingen | Germany | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.