TransitionCHF Systolic Dysfunction to Congestive Heart Failure Cohort Study

NCT02323750 | Active Not Recruiting

• 1 other identifier: TransitionCHF
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Systolic Dysfunction, Transition, Heart Failure, Biobank

Outcome Measures

Primary Outcomes (1)

• Composite endpoint of hospitalization for heart failure and cardiovascular death

  0.5 - 13 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The DZHK TransitionCHF Cohort Study will include patients with systolic dysfunction (NYHA I), i.e. (1) patients without a history of HF symptoms and (2) patients who reversed from symptomatic HF. Patients will be recruited prospectively at the participating DZHK centres, non-DZHK university hospitals and centers.

You may qualify if:

• 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
• MWD ≥ 80% of reference values
• Written informed consent
• Age ≥ 18 years

You may not qualify if:

• 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
• Geographical reasons (e. g. patients living outside Germany or planning to move abroad)
• Inability to give informed consent (e. g. mental disorders)

Sponsors & Collaborators

• University of Göttingen: lead
• University Medical Center Goettingen: collaborator
• Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK): collaborator

Study Sites (1)

University Medical Center Goettingen

Göttingen, 37075, Germany

Location

Biospecimen

Retention: SAMPLES WITH DNA

Up to 100 mL blood and 40 mL urine are received for each patient at baseline and one follow-up. Samples are managed through the DZHK Heart bank collection (https://dzhk.de/en/dzhk-heart-bank).

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. med. Gerd Hasenfuß

Study Record Dates

• First Submitted: December 18, 2014
• First Posted: December 23, 2014
• Study Start: December 1, 2014
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: November 22, 2023

Record last verified: 2023-11

Locations

DE (1)