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

Dyspnea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00130611
• Other study ID #: BASEL III - Private Practice
• Secondary ID: PP00B-102853/104
• Status: Completed
• Phase: Phase 4
• First received: August 12, 2005
• Last updated: May 28, 2013
• Start date: January 2004
• Est. completion date: January 2011

Study information

• Verified date: May 2013
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: January 2011
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Dyspnea

Intervention

Other:
• BNP measurement

• Clinical examination

Locations

Country	Name	City	State
Germany	Private practices of Baden-Wuertemberg	Freiburg
Switzerland	Private practices of Kanton Aargau	Aarau	Aargau
Switzerland	Private Practice of Kanton Schwyz	Altendorf	Schwyz
Switzerland	Private Practices of Kanton Basel Stadt	Basel
Switzerland	Private Practices of Kanton Basel-Landschaft	Basel-Landschaft
Switzerland	Private Practices of Kanton Graubünden	Chur
Switzerland	Private practices in Kanton Obwalden	Sarnen
Switzerland	Private practices of Kanton Solothurn	Solothurn
Switzerland	Private practices of Kanton St. Gallen	St. Gallen

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland	Swiss National Science Foundation

Countries where clinical trial is conducted

Germany,  Switzerland, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total medical cost within 3 months		3 months	No
Secondary	Hospitalisation		1 month	No
Secondary	Time interval to the initiation of the most appropriate therapy		1 month	No
Secondary	therapy		1 month	No
Secondary	3-month mortality		3 month	No
Secondary	Dyspnea (New York Heart Association [NYHA]) at 3 months		3 months	No
Secondary	12-month mortality		12 months	No
Secondary	12-month total medical cost		12 months	No
Secondary	Cost-effectiveness		12 months	No

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