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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Michael Behnes, University Hospital Mannheim
ClinicalTrials.gov Identifier:
NCT00143793
First received: August 31, 2005
Last updated: February 6, 2012
Last verified: February 2012
History of Changes
  Purpose

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 Phase
Dyspnea
Peripheral Edema
 Phase 4

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Hospital Mannheim:

Biospecimen Retention:   Samples Without DNA

Peripheral blood samples


Estimated Enrollment: 400
Study Start Date: June 2005
Estimated Study Completion Date: June 2015
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
  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients suffering from dyspnea and peripheral edema

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00143793

Locations
Germany
Medical Faculty Mannheim, University of Heidelberg
Mannheim, Baden-Württemberg, Germany, 68167
Sponsors and Collaborators
University Hospital Mannheim
Investigators
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
  More Information

No publications provided

Responsible Party: Michael Behnes, Dr. med., University Hospital Mannheim
ClinicalTrials.gov Identifier: NCT00143793     History of Changes
Other Study ID Numbers: 80/05
Study First Received: August 31, 2005
Last Updated: February 6, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University Hospital Mannheim:
natruretic peptides
NT-proBNP
new biomarkers
congestive heart failure
 atrial fibrillation
acute myocardial infarction
lung embolism

Additional relevant MeSH terms:
Dyspnea
Edema
Heart Failure
Respiration Disorders
Respiratory Tract Diseases
 Signs and Symptoms, Respiratory
Signs and Symptoms
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 22, 2013