Clinical trial NCT00143793: NT-proBNP and New Biomarkers in Patients With Dyspnea and/or Peripheral Edema
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dyspnea
Peripheral Edema
Keywords: natruretic peptides
NT-proBNP
new biomarkers
congestive heart failure
atrial fibrillation
acute myocardial infarction
lung embolism
Lead sponsor: Universitätsmedizin Mannheim
Sponsor class: OTHER
First posted: 2005-09-02
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients suffering from dyspnea and peripheral edema

Brief summary: 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: 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 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Mannheim
country: Germany
facility: Medical Faculty Mannheim, University of Heidelberg
state: Baden-Württemberg
Study officials:
affiliation: First Department of Medicine, University Medical Centre Mannheim
name: Martina Brueckmann, MD
role: STUDY_CHAIR
affiliation: First Department of Medicine, University Medical Centre Mannheim
name: Martin Borggrefe, MD
role: STUDY_CHAIR
affiliation: Institute of Clinical Chemistry, University Medical Centre Mannheim
name: Michael Neumaier, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Institute of Clinical Chemistry, University Medical Centre Mannheim
name: Parviz Ahmad-Nejad, MD
role: STUDY_CHAIR
affiliation: First Department of Medicine, University Medical Centre Mannheim
name: Michael Behnes, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: First Department of Medicine, University Medical Centre Mannheim
name: Ursula Hoffmann, MD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.