NT-proBNP and New Biomarkers in Patients With Dyspnea and/or Peripheral Edema
- Conditions
- DyspneaPeripheral Edema
- Registration Number
- NCT00143793
- Lead Sponsor
- Universitätsmedizin Mannheim
- Brief Summary
The objectives of this study are to:
* 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.
- Detailed Description
Primary endpoint:
* 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 400
- Age 18-90 years
- Dyspnea or/and peripheral edema
- Informed consent
- Renal insufficiency with creatinine > 2.8mg/dl
- Anemia (hemoglobin < 8.0mg/dl)
- Pregnancy
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Medical Faculty Mannheim, University of Heidelberg
🇩🇪Mannheim, Baden-Württemberg, Germany