TransitionCHF Systolic Dysfunction to Congestive Heart Failure Cohort Study

Systolic Dysfunction, Transition, Heart Failure, Biobank Clinical Trial

— TransitionCHF  

Official title:

Systolic Dysfunction to Congestive Heart Failure Cohort Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02323750
• Other study ID #: TransitionCHF
• Status: Active, not recruiting
• 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
• 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

Related Conditions & MeSH terms

• Heart Failure
• Systolic Dysfunction, Transition, Heart Failure, Biobank
• Systolic Murmurs

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