B-type Natriuretic Peptide for Acute Shortness of Breath EvaLuation (BASEL) Study - Private Practice

NCT ID: NCT00130611

Last Updated: 2013-05-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 250 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-01-31
• Study Completion Date: 2011-01-31

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.

Detailed Description

Background: Most patients with dyspnea primarily consult physicians in private practice. Heart failure and pulmonary disease are "epidemic" disorders and account for the majority of cases of dyspnea. There are approximately 24 million individuals in the United States with chronic obstructive pulmonary disease and another 10 million persons suffer from asthma. These illnesses generate in excess of 17 million physician office visits a year at a cost of over $10.4 billion. In addition, there are nearly 1.5 million new cases of heart failure in North America and Europe every year. The total direct cost of care for heart failure exceed $38 billion in the United States per year. Therefore, cost-effective management of these diseases is of paramount importance. Unfortunately, the rapid and accurate differentiation of heart failure from other causes of dyspnea in private practice is challenging. The symptoms of heart failure may be nonspecific, and signs are not sensitive enough and considerably overlap with those of pulmonary disease. In addition, signs of volume overload take time to evolve and may be completely absent in patients with acute heart failure.

B-type natriuretic peptide (BNP) is a neurohormone secreted from the cardiac ventricles in response to ventricular volume expansion and pressure overload. BNP levels are significantly higher in patients with congestive heart failure as compared to patients with dyspnea due to other causes. Recently, the researchers were able to show that the use of BNP levels significantly improves the management of patients with acute dyspnea in the emergency department. As a simple, non-expensive assay easily applicable in private practice is available, rapid measurement of BNP might also be very helpful in establishing or excluding the diagnosis of heart failure in patients presenting with acute dyspnea in private practice.

Aim: 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.

Primary endpoint: Total medical cost within 3 months. Secondary endpoints: Hospitalisation, time interval to the initiation of the most appropriate therapy, 3-month mortality, dyspnea (NYHA) at 3 months, 12-month mortality, 12-month total medical cost, cost-effectiveness.

Patients and Methods: The trial is designed to enrol 250 patients presenting with acute dyspnea to physicians in private practice. Patients will be randomly assigned 1:1 into a control group using evaluation of patients according to local standards without the use of BNP (or other natriuretic peptides) and to a BNP group with early testing for BNP by a rapid point-of-care assay during the first consultation in each private practice.

Expected results: It is the researchers' hypothesis that a BNP guided diagnostic strategy will improve the evaluation and management and thereby reduce total cost of diagnosis and treatment.

Significance: Given the significant morbidity associated with dyspnea, as well as the enormous expenses associated with heart failure and pulmonary disease, BNP testing could represent a major advance in clinical medicine. In addition, BNP testing in the appropriate clinical setting may prove very helpful in the attempts to reduce cost of health care to society without reducing (but possibly increasing) the quality of health care.

Conditions

Dyspnea

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Study Groups

BNP blinded therapy

Clinical treatment without knowledge of BNP levels

Group Type: PLACEBO_COMPARATOR

Clinical examination

Intervention Type: OTHER

BNP guided therapy

Clinical treatment based on clinical examination and BNP-levels

Group Type: EXPERIMENTAL

BNP measurement

Intervention Type: OTHER

Clinical examination

Intervention Type: OTHER

Interventions

BNP measurement

Intervention Type: OTHER

Clinical examination

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Acute dyspnoea is the main symptom

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Swiss National Science Foundation

OTHER

Sponsor Role: collaborator

University Hospital, Basel, Switzerland

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christian Mueller, Prof.

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Basel, Switzerland

Locations

Private practices of Baden-Wuertemberg

Freiburg im Breisgau, Freiburg, Germany

Private Practices of Kanton Basel-Landschaft

Basel-Landschaft, Basel-Landschaft, Switzerland

Private Practices of Kanton Basel Stadt

Basel, Basel, Switzerland

Private practices of Kanton Aargau

Aarau, Canton of Aargau, Switzerland

Private Practice of Kanton Schwyz

Altendorf, Canton of Schwyz, Switzerland

Private practices of Kanton Solothurn

Solothurn, Canton of Solothurn, Switzerland

Private practices of Kanton St. Gallen

Sankt Gallen, Canton of St. Gallen, Switzerland

Private Practices of Kanton Graubünden

Chur, Chur, Switzerland

Private practices in Kanton Obwalden

Sarnen, Sarnen, Switzerland

Countries

Germany; Switzerland

References

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.

Reference Type: BACKGROUND

PMID: 14960741 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 22550938 (View on PubMed)

Related Links

http://www.dyspnea.ch

Related Info

Other Identifiers

PP00B-102853/1

Identifier Type: -

Identifier Source: secondary_id

04.001

Identifier Type: -

Identifier Source: secondary_id

287/03

Identifier Type: -

Identifier Source: secondary_id

BASEL III - Private Practice

Identifier Type: -

Identifier Source: org_study_id