NCT00410293

Brief Summary

Diagnostic uncertainty in patients with complaints of shortness of breath presenting to the Emergency Department of a hospital may delay treatment and proper care. In patients with shortness of breath due to heart failure increased plasma levels of NT-pro-B-type natriuretic peptide (NT-proBNP) can be demonstrated. The use of NT-proBNP as a biomarker for heart failure in patients presenting to the emergency department with dyspnea might improve care and reduce length of hospital stay. To investigate the effect of NT-proBNP testing on patient care and time to discharge the NT-proBNP test will be randomized. In patients in the study group, the NT-proBNP plasma level is determined at admission and the physician in charge will immediately receive the result of the test. In patients in the control group blood will be sampled but the physician will recieve no information on the NT-proBNP plasma level. In our study we will investigate the effect of introduction of NT-proBNP as biomarker for heart failure on treatment, time to discharge and costs.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
500

participants targeted

Target at P75+ for not_applicable heart-failure

Timeline
Completed

Started Dec 2004

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

December 1, 2004

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2006

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 11, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 12, 2006

Completed
Last Updated

December 12, 2006

Status Verified

December 1, 2006

First QC Date

December 11, 2006

Last Update Submit

December 11, 2006

Conditions

Heart FailureDyspnea

Keywords

Heart failureDiagnosticNatriuretic peptideNT-pro B-type natriuretic peptideLength of stayCosts

Outcome Measures

Primary Outcomes (2)

  • Time to discharge

  • Cost of treatment

Secondary Outcomes (6)

  • Duration of stay at the ED

  • Proportion of patients admitted to the hospital

  • Proportion of patients admitted to an intensive or coronary care unit

  • Specialist consultations

  • Medical treatment

  • +1 more secondary outcomes

Interventions

NT-proBNP testingPROCEDURE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18 years or older
  • Acute dyspnea as their most prominent complaint

You may not qualify if:

  • Acute dyspnea due to a trauma
  • Acute dyspnea due to cardiogenic shock
  • Renal failure requiring dialysis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Erasmus MC

Rotterdam, 3015 CE, Netherlands

Location

MeSH Terms

Conditions

Heart FailureDyspneaDisease

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesRespiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and SymptomsPathologic Processes

Study Officials

  • Anton H. van den Meiracker, MD, PhD

    Erasmus Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 11, 2006

First Posted

December 12, 2006

Study Start

December 1, 2004

Study Completion

August 1, 2006

Last Updated

December 12, 2006

Record last verified: 2006-12

Locations

NL(1)