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

NCT ID: NCT00143793

Last Updated: 2020-08-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-06-30

Study Completion Date

2019-12-31

Brief Summary

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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.

Detailed Description

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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

Conditions

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Dyspnea Peripheral Edema

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universitätsmedizin Mannheim

OTHER

Sponsor Role lead

Responsible Party

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Michael Behnes

Dr. med.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Martina Brueckmann, MD

Role: STUDY_CHAIR

First Department of Medicine, University Medical Centre Mannheim

Martin Borggrefe, MD

Role: STUDY_CHAIR

First Department of Medicine, University Medical Centre Mannheim

Michael Neumaier, MD

Role: PRINCIPAL_INVESTIGATOR

Institute of Clinical Chemistry, University Medical Centre Mannheim

Parviz Ahmad-Nejad, MD

Role: STUDY_CHAIR

Institute of Clinical Chemistry, University Medical Centre Mannheim

Michael Behnes, MD

Role: PRINCIPAL_INVESTIGATOR

First Department of Medicine, University Medical Centre Mannheim

Ursula Hoffmann, MD

Role: STUDY_CHAIR

First Department of Medicine, University Medical Centre Mannheim

Locations

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Medical Faculty Mannheim, University of Heidelberg

Mannheim, Baden-Wurttemberg, Germany

Site Status

Countries

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Germany

References

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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.

Reference Type DERIVED
PMID: 26072112 (View on PubMed)

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.

Reference Type DERIVED
PMID: 24146089 (View on PubMed)

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.

Reference Type DERIVED
PMID: 23851388 (View on PubMed)

Other Identifiers

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80/05

Identifier Type: -

Identifier Source: org_study_id

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