NT-proBNP and New Biomarkers in Patients With Dyspnea and/or Peripheral Edema (MANPRO)
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|ClinicalTrials.gov Identifier: NCT00143793|
Recruitment Status : Active, not recruiting
First Posted : September 2, 2005
Last Update Posted : November 23, 2016
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.
|Condition or disease||Phase|
|Dyspnea Peripheral Edema||Phase 4|
- Sensitivity and specificity of biomarker measurements for discrimination of heart failure from dyspnea of other origin.
- 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
|Study Type :||Observational|
|Estimated Enrollment :||400 participants|
|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|
|Study Start Date :||June 2005|
|Estimated Study Completion Date :||June 2017|
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): NCT00143793
|Medical Faculty Mannheim, University of Heidelberg|
|Mannheim, Baden-Württemberg, Germany, 68167|
|Study Chair:||Martina Brueckmann, MD||First Department of Medicine, University Medical Centre Mannheim|
|Study Chair:||Martin Borggrefe, MD||First Department of Medicine, University Medical Centre Mannheim|
|Principal Investigator:||Michael Neumaier, MD||Institute of Clinical Chemistry, University Medical Centre Mannheim|
|Study Chair:||Parviz Ahmad-Nejad, MD||Institute of Clinical Chemistry, University Medical Centre Mannheim|
|Principal Investigator:||Michael Behnes, MD||First Department of Medicine, University Medical Centre Mannheim|
|Study Chair:||Ursula Hoffmann, MD||First Department of Medicine, University Medical Centre Mannheim|