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Completed

NCT Number: NCT00143793

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

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.

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Key information

Conditions

Dyspnea Arrhythmias, Cardiac Atrial Fibrillation Cardiovascular Diseases Embolism Embolism and Thrombosis Heart Diseases Heart Failure Lung Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Peripheral Edema Pulmonary Embolism Respiration Disorders Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory Vascular Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Medical Faculty Mannheim, University of Heidelberg

Mannheim, Baden-Wurttemberg, 68167, Germany

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Sponsors and collaborators

Lead sponsor

Universitätsmedizin Mannheim

Other

Registry information

Official study 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

Acronym: MANPRO

Important dates

Study start
2005
Primary completion
2018
Study completion
2019
First posted
Sep 2, 2005
Registry last updated
Aug 27, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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