NT-proBNP and New Biomarkers in Patients With Dyspnea and/or Peripheral Edema
NCT ID: NCT00143793
Last Updated: 2020-08-27
Study Results
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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COMPLETED
400 participants
OBSERVATIONAL
2005-06-30
2019-12-31
Brief Summary
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* Evaluate the sensitivity and specificity of NT-proBNP (N-terminal prohormone brain natriuretic peptide) and new biomarker measurements for the diagnosis of heart failure in patients with acute dyspnea and/or edema.
* Determine the exact biomarker cut-off point(s) for the differentiation of healthy persons, patients with heart failure and patients with dyspnea of other origin.
* Evaluate treatment costs in patients with dyspnea under special consideration of NT-proBNP measurement.
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Detailed Description
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* Sensitivity and specificity of biomarker measurements for discrimination of heart failure from dyspnea of other origin.
Secondary endpoints:
* Determination of Cut-off(s)
* Discrimination of cardiac and non-cardiac diseases causing to dyspnea or peripheral edema
* Determination of treatment costs of the initial hospital stay
* Evaluation of resource savings when implementing NT-proBNP for determination of diagnosis.
* Time to diagnosis.
* Hospitalization rate /Intensive care treatment rate between day 1 and 28
* Duration of initial hospital stay
* 30-day re-hospitalization rate
* 30 day mortality rate and adverse event rate
* 1 and 5 year mortality rates
* 1 and 5 year rehospitalization rates
Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* Dyspnea or/and peripheral edema
* Informed consent
Exclusion Criteria
* Anemia (hemoglobin \< 8.0mg/dl)
* Pregnancy
18 Years
90 Years
ALL
No
Sponsors
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Universitätsmedizin Mannheim
OTHER
Responsible Party
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Michael Behnes
Dr. med.
Principal Investigators
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Martina Brueckmann, MD
Role: STUDY_CHAIR
First Department of Medicine, University Medical Centre Mannheim
Martin Borggrefe, MD
Role: STUDY_CHAIR
First Department of Medicine, University Medical Centre Mannheim
Michael Neumaier, MD
Role: PRINCIPAL_INVESTIGATOR
Institute of Clinical Chemistry, University Medical Centre Mannheim
Parviz Ahmad-Nejad, MD
Role: STUDY_CHAIR
Institute of Clinical Chemistry, University Medical Centre Mannheim
Michael Behnes, MD
Role: PRINCIPAL_INVESTIGATOR
First Department of Medicine, University Medical Centre Mannheim
Ursula Hoffmann, MD
Role: STUDY_CHAIR
First Department of Medicine, University Medical Centre Mannheim
Locations
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Medical Faculty Mannheim, University of Heidelberg
Mannheim, Baden-Wurttemberg, Germany
Countries
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References
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Hoffmann U, Espeter F, Weiss C, Ahmad-Nejad P, Lang S, Brueckmann M, Akin I, Neumaier M, Borggrefe M, Behnes M. Ischemic biomarker heart-type fatty acid binding protein (hFABP) in acute heart failure - diagnostic and prognostic insights compared to NT-proBNP and troponin I. BMC Cardiovasc Disord. 2015 Jun 14;15:50. doi: 10.1186/s12872-015-0026-0.
Behnes M, Brueckmann M, Lang S, Weiss C, Ahmad-Nejad P, Neumaier M, Borggrefe M, Hoffmann U. Connective tissue growth factor (CTGF/CCN2): diagnostic and prognostic value in acute heart failure. Clin Res Cardiol. 2014 Feb;103(2):107-16. doi: 10.1007/s00392-013-0626-6. Epub 2013 Oct 22.
Behnes M, Brueckmann M, Lang S, Espeter F, Weiss C, Neumaier M, Ahmad-Nejad P, Borggrefe M, Hoffmann U. Diagnostic and prognostic value of osteopontin in patients with acute congestive heart failure. Eur J Heart Fail. 2013 Dec;15(12):1390-400. doi: 10.1093/eurjhf/hft112. Epub 2013 Jul 12.
Other Identifiers
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80/05
Identifier Type: -
Identifier Source: org_study_id
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