Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    Transitionchf
Previous Study | Return to List | Next Study

TransitionCHF Systolic Dysfunction to Congestive Heart Failure Cohort Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02323750
Recruitment Status : Recruiting
First Posted : December 23, 2014
Last Update Posted : May 9, 2017
Sponsor:
Collaborators:
University Medical Center Goettingen
Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)
Information provided by (Responsible Party):
Gerd Hasenfus, University of Göttingen

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
Systolic Dysfunction, Transition, Heart Failure, Biobank

Layout table for study information
Study Type : Observational [Patient Registry]
Estimated Enrollment : 1500 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: Systolic Dysfunction to Congestive Heart Failure Cohort Study
Study Start Date : December 2014
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure




Primary Outcome Measures :
  1. composite endpoint of hospitalization for heart failure and cardiovascular death [ Time Frame: 5 Years ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 95 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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 seven participating DZHK centres and eight external partners from the ALKK network (German Working Group of Leading Hospital-based Cardiologists) and university hospitals.
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)
  • 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02323750


Contacts
Layout table for location contacts
Contact: Gerd Hasenfuß, Prof 49-551-39-20400 rfaber@med.uni-goettingen.de
Contact: Frank Edelmann, Dr 49-551-39-22658 fedelmann@med.uni-goettingen.de

Locations
Layout table for location information
Germany
University Medical Center Goettingen Recruiting
Göttingen, Germany, 37075
Contact: Frank Edelmann, Dr    49-551-39-22658    fedelmann@med.uni-goettingen.de   
Sponsors and Collaborators
University of Göttingen
University Medical Center Goettingen
Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)

Additional Information:

Layout table for additonal information
Responsible Party: Gerd Hasenfus, Prof. Dr. med. Gerd Hasenfuß, University of Göttingen
ClinicalTrials.gov Identifier: NCT02323750     History of Changes
Other Study ID Numbers: TransitionCHF
First Posted: December 23, 2014    Key Record Dates
Last Update Posted: May 9, 2017
Last Verified: May 2017
Additional relevant MeSH terms:
Layout table for MeSH terms
Heart Failure
Heart Diseases
Cardiovascular Diseases