Evaluation of the sensitivity and specificity of NT-proBNP-measurement for the diagnosis of heart failure in patients with acute dyspnoea and/or edema. Determination of the exact NT-proBNP-cut-off point(s) for the differentiation of healthy persons, patients with acute heart failure and patients with dyspnoea of other origin.

Evaluation of treatment costs in patients with dyspnoea under special consideration of NT-proBNP-measurement.

Condition	Phase
Heart Failure Edema	Phase IV

Further Study Details: 

Expected Total Enrollment:  400

Primary endpoint:

Sensitivity and specificity of NT-proBNP measurement for discrimination of heart failure from dyspnoea of other origin.

Secondary endpoints:

Determination of NT-proBNP-Cut-off(s) Determination of treatment costs Evaluation of resource savings when implementing NT-proBNP for determination of diagnosis.

Time to diagnosis. Hospitalization rate /Intensive care treatment rate Duration of hospital stay 30-Day re-hospitalization rate 30 day mortality rate and adverse event rate

Ages Eligible for Study:  18 Years   -   90 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• Age 18-90 years
• Dyspnoea or/and peripheral edema
• Informed consent

Exclusion Criteria:

• Renal insufficiency with creatinine > 2.8mg/dl
• Anemia (hemoglobin < 8.0mg/dl)
• Pregnancy

Please refer to this study by ClinicalTrials.gov identifier  NCT00143793

Martina Brueckmann, MD      0049621383-  Ext. 2875    martina.brueckmann@med.ma.uni-heidelberg.de

Germany, Baden-Württemberg
      Faculty of Clinical Medicine Mannheim of the University of Heidelberg, Mannheim,  Baden-Württemberg,  68167,  Germany; Recruiting

Study chairs or principal investigators

Martina Brueckmann, MD,  Principal Investigator,  I. Medical Department, University Hospital Mannheim   
Martin Borggrefe, MD,  Study Director,  I. Medical Department, University Hospital Mannheim   
Michael Neumaier, MD,  Study Chair,  Institute of Clinical Chemistry, University Hospital Mannheim   
Parviz Ahmad-Nejad, MD,  Study Chair,  Institute of Clinical Chemistry, University Hospital Mannheim   

Study ID Numbers:  80/05; not applicable
Last Updated:  September 1, 2005
Record first received:  August 31, 2005
ClinicalTrials.gov Identifier:  NCT00143793
Health Authority: Germany: Federal Institute for Drugs and Medicinal Devices
ClinicalTrials.gov processed this record on 2005-09-06