NT-proBNP and New Biomarkers in Patients With Dyspnea and/or Peripheral Edema (MANPRO)
August 26, 2020 updated by: Michael Behnes, Universitätsmedizin Mannheim
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
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.
Study Overview
Status
Completed
Conditions
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
Study Type
Observational
Enrollment (Anticipated)
400
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Baden-Württemberg
-
Mannheim, Baden-Württemberg, Germany, 68167
- Medical Faculty Mannheim, University of Heidelberg
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 90 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Patients suffering from dyspnea and peripheral edema
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Hoffmann U, Espeter F, Weiss C, Ahmad-Nejad P, Lang S, Brueckmann M, Akin I, Neumaier M, Borggrefe M, Behnes M. Ischemic biomarker heart-type fatty acid binding protein (hFABP) in acute heart failure - diagnostic and prognostic insights compared to NT-proBNP and troponin I. BMC Cardiovasc Disord. 2015 Jun 14;15:50. doi: 10.1186/s12872-015-0026-0.
- Behnes M, Brueckmann M, Lang S, Weiss C, Ahmad-Nejad P, Neumaier M, Borggrefe M, Hoffmann U. Connective tissue growth factor (CTGF/CCN2): diagnostic and prognostic value in acute heart failure. Clin Res Cardiol. 2014 Feb;103(2):107-16. doi: 10.1007/s00392-013-0626-6. Epub 2013 Oct 22.
- Behnes M, Brueckmann M, Lang S, Espeter F, Weiss C, Neumaier M, Ahmad-Nejad P, Borggrefe M, Hoffmann U. Diagnostic and prognostic value of osteopontin in patients with acute congestive heart failure. Eur J Heart Fail. 2013 Dec;15(12):1390-400. doi: 10.1093/eurjhf/hft112. Epub 2013 Jul 12.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 1, 2005
Primary Completion (Actual)
December 1, 2018
Study Completion (Actual)
December 1, 2019
Study Registration Dates
First Submitted
August 31, 2005
First Submitted That Met QC Criteria
August 31, 2005
First Posted (Estimate)
September 2, 2005
Study Record Updates
Last Update Posted (Actual)
August 27, 2020
Last Update Submitted That Met QC Criteria
August 26, 2020
Last Verified
August 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 80/05
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.