Clinical trial NCT02323750: TransitionCHF Systolic Dysfunction to Congestive Heart Failure Cohort Study
Official title: Systolic Dysfunction to Congestive Heart Failure Cohort Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Systolic Dysfunction, Transition, Heart Failure, Biobank
Lead sponsor: University of Göttingen
Sponsor class: OTHER
Collaborators: name: University Medical Center Goettingen
name: Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)
First posted: 2014-12-23
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Composite endpoint of hospitalization for heart failure and cardiovascular death
timeFrame: 0.5 - 13 years
Secondary outcomes:
Other outcomes:
Locations:
city: Göttingen
country: Germany
facility: University Medical Center Goettingen
Study officials:
References: