NT-proBNP and New Biomarkers in Patients With Dyspnea and/or Peripheral Edema
This trial is active, not recruiting.
|Conditions||dyspnea, peripheral edema|
|Start date||June 2005|
|End date||January 2016|
|Trial size||400 participants|
|Trial identifier||NCT00143793, 80/05|
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.
Male or female participants from 18 years up to 90 years old.
Inclusion Criteria: - Age 18-90 years - Dyspnea or/and peripheral edema - Informed consent Exclusion Criteria: - Renal insufficiency with creatinine > 2.8mg/dl - Anemia (hemoglobin < 8.0mg/dl) - Pregnancy
|Official title||Mannheim NT-proBNP Study (MANPRO) Evaluating NT-proBNP and New Biomarkers in Patients Suffering From Dyspnea and/or Peripheral Edema for the Differential Diagnosis of Congestive Heart Failure|
|Principal investigator||Michael Neumaier, MD|
|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|
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