TransitionCHF Systolic Dysfunction to Congestive Heart Failure Cohort Study (TransitionCHF)

November 21, 2023 updated by: Gerd Hasenfus, University of Göttingen

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.

Study Overview

Status

Active, not recruiting

Conditions

Study Type

Observational

Enrollment (Actual)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Göttingen, Germany, 37075
        • University Medical Center Goettingen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 95 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Göttingen

Collaborators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2014

Primary Completion (Estimated)

September 30, 2027

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

December 18, 2014

First Submitted That Met QC Criteria

December 18, 2014

First Posted (Estimated)

December 23, 2014

Study Record Updates

Last Update Posted (Estimated)

November 22, 2023

Last Update Submitted That Met QC Criteria

November 21, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TransitionCHF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Systolic Dysfunction, Transition, Heart Failure, Biobank

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