NCT00143793

NT-proBNP and New Biomarkers in Patients With Dyspnea and/or Peripheral Edema

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 400 (estimated)
• Sponsor: Universitätsmedizin Mannheim · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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

Conditions

• Dyspnea
• Peripheral Edema

Timeline

• Start date: 2005-06-01
• Primary completion: 2018-12-01
• Completion: 2019-12-01
• First posted: 2005-09-02
• Last updated: 2020-08-27

Locations

1 site across 1 country: Germany