Ireland
--:--IST
Active, not recruiting Observational

TransitionCHF Systolic Dysfunction to Congestive Heart Failure Cohort Study

NCT02323750 · tracked via the Priya Life Science Germany tracker
Phase
Observational
Started
2014-12-01
Last updated
2023-11-22

Condition(s) studied

Systolic Dysfunction, Transition, Heart Failure, Biobank

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Composite endpoint of hospitalization for heart failure and cardiovascular death — 0.5 - 13 years

Trial sites (1)

FacilityCityRegionStatus
University Medical Center Goettingen Göttingen Germany

More University of Göttingen trials in Germany

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT02323750 on ClinicalTrials.gov ↗ ← All trials in Germany