TransitionCHF Systolic Dysfunction to Congestive Heart Failure Cohort Study

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Systolic Dysfunction, Transition, Heart Failure, Biobank Cardiovascular Diseases Heart Diseases Heart Failure

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Medical Center Goettingen

Göttingen, 37075, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Composite endpoint of hospitalization for heart failure and cardiovascular death

Time frame: 0.5 - 13 years

Sponsors and collaborators

Lead sponsor

University of Göttingen

Other

Collaborators

Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)
University Medical Center Goettingen

Registry information

Official study title

Systolic Dysfunction to Congestive Heart Failure Cohort Study

Acronym: TransitionCHF

Important dates

Study start: 2014
Primary completion: 2027
Study completion: 2027
First posted: Dec 23, 2014
Registry last updated: Nov 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Active, Not Recruiting