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
  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:


Further study details as provided by Universitätsmedizin 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Universitätsmedizin 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 by Universitätsmedizin Mannheim

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 Universitätsmedizin 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
Cardiovascular Diseases
Heart Diseases
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms
Signs and Symptoms, Respiratory

ClinicalTrials.gov processed this record on October 29, 2014