This trial is active, not recruiting.

Conditions dyspnea, peripheral edema
Phase phase 4
Sponsor Universitätsmedizin Mannheim
Start date June 2005
End date June 2017
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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective

Eligibility Criteria

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

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Universitätsmedizin Mannheim.