TransitionCHF Systolic Dysfunction to Congestive Heart Failure Cohort Study

Active, not recruiting

• Conditions: Systolic Dysfunction, Transition, Heart Failure, Biobank

• Registration Number: NCT02323750
• Lead Sponsor: University of Göttingen

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-12-01
• Study First Submitted: 2014-12-18
• Study First Submitted QC: 2014-12-18
• Study First Posted: 2014-12-23
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-21
• Last Update Posted: 2023-11-22
• Primary Completion: 2027-09-30
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 1000

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Composite endpoint of hospitalization for heart failure and cardiovascular death	0.5 - 13 years

Trial Locations

Locations (1)

University Medical Center Goettingen; 🇩🇪 Göttingen, Germany