NCT00143793

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2005

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2005

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 31, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 2, 2005

Completed
13.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

August 27, 2020

Status Verified

August 1, 2020

Enrollment Period

13.5 years

First QC Date

August 31, 2005

Last Update Submit

August 26, 2020

Conditions

DyspneaPeripheral Edema

Keywords

natruretic peptidesNT-proBNPnew biomarkerscongestive heart failureatrial fibrillationacute myocardial infarctionlung embolism

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients suffering from dyspnea and peripheral edema

You may qualify if:

  • Age 18-90 years
  • Dyspnea or/and peripheral edema
  • Informed consent

You may not qualify if:

  • Renal insufficiency with creatinine \> 2.8mg/dl
  • Anemia (hemoglobin \< 8.0mg/dl)
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical Faculty Mannheim, University of Heidelberg

Mannheim, Baden-Wurttemberg, 68167, Germany

Location

Related Publications (3)

  • 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.

    PMID: 26072112DERIVED

  • 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.

    PMID: 24146089DERIVED

  • 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.

    PMID: 23851388DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Peripheral blood samples

MeSH Terms

Conditions

DyspneaHeart FailureAtrial FibrillationPulmonary Embolism

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and SymptomsHeart DiseasesCardiovascular DiseasesArrhythmias, CardiacPathologic ProcessesLung DiseasesEmbolismEmbolism and ThrombosisVascular Diseases

Study Officials

  • Martina Brueckmann, MD

    First Department of Medicine, University Medical Centre Mannheim

    STUDY CHAIR

  • Martin Borggrefe, MD

    First Department of Medicine, University Medical Centre Mannheim

    STUDY CHAIR

  • Michael Neumaier, MD

    Institute of Clinical Chemistry, University Medical Centre Mannheim

    PRINCIPAL INVESTIGATOR

  • Parviz Ahmad-Nejad, MD

    Institute of Clinical Chemistry, University Medical Centre Mannheim

    STUDY CHAIR

  • Michael Behnes, MD

    First Department of Medicine, University Medical Centre Mannheim

    PRINCIPAL INVESTIGATOR

  • Ursula Hoffmann, MD

    First Department of Medicine, University Medical Centre Mannheim

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. med.

Study Record Dates

First Submitted

August 31, 2005

First Posted

September 2, 2005

Study Start

June 1, 2005

Primary Completion

December 1, 2018

Study Completion

December 1, 2019

Last Updated

August 27, 2020

Record last verified: 2020-08

Locations

DE(1)