We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00143793
First Posted: September 2, 2005
Last Update Posted: November 23, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Michael Behnes, Universitätsmedizin Mannheim
  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 Michael Behnes, Universitätsmedizin Mannheim:

Biospecimen Retention:   Samples Without DNA
Peripheral blood samples

Estimated Enrollment: 400
Study Start Date: June 2005
Estimated Study Completion Date: June 2017
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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Michael Behnes, Dr. med., Universitätsmedizin Mannheim
ClinicalTrials.gov Identifier: NCT00143793     History of Changes
Other Study ID Numbers: 80/05
First Submitted: August 31, 2005
First Posted: September 2, 2005
Last Update Posted: November 23, 2016
Last Verified: November 2016

Keywords provided by Michael Behnes, Universitätsmedizin Mannheim:
natruretic peptides
NT-proBNP
new biomarkers
congestive heart failure
atrial fibrillation
acute myocardial infarction
lung embolism

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