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

Dyspnea Clinical Trial

— MANPRO  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00143793
• Other study ID #: 80/05
• Status: Completed
• Start date: June 2005
• Est. completion date: December 2019

Study information

• Verified date: August 2020
• Source: Universitätsmedizin Mannheim
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: December 2019
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Dyspnea
• Edema
• Peripheral Edema

Locations

Country	Name	City	State
Germany	Medical Faculty Mannheim, University of Heidelberg	Mannheim	Baden-Württemberg

Sponsors (1)

Lead Sponsor	Collaborator
Universitätsmedizin Mannheim

Country where clinical trial is conducted

Germany,