TransitionCHF Systolic Dysfunction to Congestive Heart Failure Cohort Study

Systolic Dysfunction to Congestive Heart Failure Cohort Study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02323750

Acronym

TransitionCHF

Enrollment

1000

Registered

2014-12-23

Start date

2014-12-01

Completion date

2027-12-31

Last updated

2023-11-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Systolic Dysfunction, Transition, Heart Failure, Biobank

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Composite endpoint of hospitalization for heart failure and cardiovascular death	0.5 - 13 years

Countries

Germany

Outcome results