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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02323750
Other study ID # TransitionCHF
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date December 1, 2014
Est. completion date December 31, 2027

Study information

Verified date November 2023
Source University of Göttingen
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical 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. 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 1000
Est. completion date December 31, 2027
Est. primary completion date September 30, 2027
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - 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 - 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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Germany University Medical Center Goettingen Göttingen

Sponsors (3)

Lead Sponsor Collaborator
University of Göttingen Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK), University Medical Center Goettingen

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Composite endpoint of hospitalization for heart failure and cardiovascular death 0.5 - 13 years