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TransitionCHF Systolic Dysfunction to Congestive Heart Failure Cohort Study

NCT ID: NCT02323750

Last Updated: 2023-11-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-12-01

Study Completion Date

2027-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Systolic Dysfunction, Transition, Heart Failure, Biobank

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Medical Center Goettingen

OTHER

Sponsor Role collaborator

Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)

OTHER

Sponsor Role collaborator

University of Göttingen

OTHER

Sponsor Role lead

Responsible Party

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Gerd Hasenfus

Prof. Dr. med. Gerd Hasenfuß

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University Medical Center Goettingen

Göttingen, , Germany

Site Status

Countries

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Germany

Other Identifiers

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TransitionCHF

Identifier Type: -

Identifier Source: org_study_id