NCT00130611

Brief Summary

Cost-effective management of heart failure and pulmonary disease is of paramount importance. Unfortunately, the rapid and accurate differentiation of heart failure from other causes of dyspnea in private practice is challenging. B-type natriuretic peptide (BNP) levels are significantly higher in patients with congestive heart failure as compared to patients with dyspnea due to other causes. As a simple, non-expensive assay easily applicable in private practice is available, rapid measurement of BNP might be very helpful in establishing or excluding the diagnosis of heart failure in patients presenting with acute dyspnea in private practice. The aim is to test the hypothesis that a BNP guided diagnostic strategy would improve the evaluation and management of patients presenting with acute dyspnea to physicians in private practice and thereby reduce total cost of diagnosis and treatment. The primary endpoint is total medical cost within 3 months.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
250

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jan 2004

Longer than P75 for phase_4

Geographic Reach
2 countries

9 active sites

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

January 1, 2004

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

August 12, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 15, 2005

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
Last Updated

May 29, 2013

Status Verified

May 1, 2013

Enrollment Period

6 years

First QC Date

August 12, 2005

Last Update Submit

May 28, 2013

Conditions

Dyspnea

Keywords

heart failurecost effectivenessBNPprivate practiceAcute dyspnoea

Outcome Measures

Primary Outcomes (1)

  • Total medical cost within 3 months

    3 months

Secondary Outcomes (8)

  • Hospitalisation

    1 month

  • Time interval to the initiation of the most appropriate therapy

    1 month

  • therapy

    1 month

  • 3-month mortality

    3 month

  • Dyspnea (New York Heart Association [NYHA]) at 3 months

    3 months

  • +3 more secondary outcomes

Study Arms (2)

BNP blinded therapy

PLACEBO COMPARATOR

Clinical treatment without knowledge of BNP levels

Other: Clinical examination

BNP guided therapy

EXPERIMENTAL

Clinical treatment based on clinical examination and BNP-levels

Other: BNP measurementOther: Clinical examination

Interventions

BNP measurementOTHER
BNP guided therapy
Clinical examinationOTHER
BNP blinded therapyBNP guided therapy

Eligibility Criteria

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

You may qualify if:

  • Acute dyspnoea is the main symptom

You may not qualify if:

  • Age \<18 years
  • Obvious traumatic cause
  • Severe renal dysfunction (serum creatinine \> 250 umol/l)
  • Sepsis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Private practices of Baden-Wuertemberg

Freiburg im Breisgau, Freiburg, Germany

Location

Private Practices of Kanton Basel-Landschaft

Basel-Landschaft, Basel-Landschaft, 4100, Switzerland

Location

Private Practices of Kanton Basel Stadt

Basel, Basel, 4000, Switzerland

Location

Private practices of Kanton Aargau

Aarau, Canton of Aargau, 4300, Switzerland

Location

Private Practice of Kanton Schwyz

Altendorf, Canton of Schwyz, 8852, Switzerland

Location

Private practices of Kanton Solothurn

Solothurn, Canton of Solothurn, 4500, Switzerland

Location

Private practices of Kanton St. Gallen

Sankt Gallen, Canton of St. Gallen, Switzerland

Location

Private Practices of Kanton Graubünden

Chur, Chur, 7500, Switzerland

Location

Private practices in Kanton Obwalden

Sarnen, Sarnen, 6060, Switzerland

Location

Related Publications (2)

  • Mueller C, Scholer A, Laule-Kilian K, Martina B, Schindler C, Buser P, Pfisterer M, Perruchoud AP. Use of B-type natriuretic peptide in the evaluation and management of acute dyspnea. N Engl J Med. 2004 Feb 12;350(7):647-54. doi: 10.1056/NEJMoa031681.

    PMID: 14960741BACKGROUND

  • Burri E, Hochholzer K, Arenja N, Martin-Braschler H, Kaestner L, Gekeler H, Hatziisaak T, Buttiker M, Fraulin A, Potocki M, Breidthardt T, Reichlin T, Socrates T, Twerenbold R, Mueller C. B-type natriuretic peptide in the evaluation and management of dyspnoea in primary care. J Intern Med. 2012 Nov;272(5):504-13. doi: 10.1111/j.1365-2796.2012.02552.x. Epub 2012 Jun 12.

    PMID: 22550938DERIVED

Related Links

MeSH Terms

Conditions

DyspneaHeart Failure

Interventions

Restraint, Physical

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and SymptomsHeart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Behavior ControlTherapeuticsImmobilizationInvestigative Techniques

Study Officials

  • Christian Mueller, Prof.

    University Hospital, Basel, Switzerland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 12, 2005

First Posted

August 15, 2005

Study Start

January 1, 2004

Primary Completion

January 1, 2010

Study Completion

January 1, 2011

Last Updated

May 29, 2013

Record last verified: 2013-05

Locations

CH(8)DE(1)