TransitionCHF Systolic Dysfunction to Congestive Heart Failure Cohort Study

Sponsor

University of Göttingen (Other)

Overall Status

Recruiting

CT.gov ID

NCT02323750

Collaborator

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

1,500

Enrollment

Location

Duration (Months)

15.6

Patients Per Site Per Month

Study Details

Study Description

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 DZHK study groups. This study will set the standard for a unique DZHK heart failure database and Biobank for innovative preclinical and clinical trials.

Condition or Disease	Intervention/Treatment	Phase
Systolic Dysfunction, Transition, Heart Failure, Biobank

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

1500 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Systolic Dysfunction to Congestive Heart Failure Cohort Study

Study Start Date :

Dec 1, 2014

Anticipated Primary Completion Date :

Dec 1, 2017

Anticipated Study Completion Date :

Dec 1, 2022

Outcome Measures

Primary Outcome Measures

composite endpoint of hospitalization for heart failure and cardiovascular death [5 Years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 95 Years

Sexes Eligible for Study:

All

Accepts 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)
No history of hospitalization for heart failure (defined as hospitalisation with symptoms of heart failure requiring initiation of therapy with a loop diuretic or escalation of a pre-existing loop diuretic therapy within 48 hours after hospital admission)
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 < 70% of normal limit)
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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Medical Center Goettingen	Göttingen		Germany	37075

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Gerd Hasenfus, Prof. Dr. med. Gerd Hasenfuß, University of Göttingen

ClinicalTrials.gov Identifier:

NCT02323750

Other Study ID Numbers:

TransitionCHF

First Posted:

Dec 23, 2014

Last Update Posted:

May 9, 2017

Last Verified:

May 1, 2017

Additional relevant MeSH terms:

Heart Failure

Systolic Murmurs

Study Results

No Results Posted as of May 9, 2017