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

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.

Study Overview

• Status: Completed
• Conditions: Dyspnea
• Intervention / Treatment: Other: Clinical examination; Other: BNP measurement

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.

• Study Type: Interventional
• Enrollment (Actual): 250
• Phase: Phase 4

Contacts and Locations

Study Locations

• Germany
  • Freiburg, Germany
    • Private practices of Baden-Wuertemberg
• Switzerland
  • Basel, Switzerland, 4000
    • Private Practices of Kanton Basel Stadt
  • Basel-Landschaft, Switzerland, 4100
    • Private Practices of Kanton Basel-Landschaft
  • Chur, Switzerland, 7500
    • Private Practices of Kanton Graubünden
  • Sarnen, Switzerland, 6060
    • Private practices in Kanton Obwalden
  • Solothurn, Switzerland, 4500
    • Private practices of Kanton Solothurn
  • St. Gallen, Switzerland
    • Private practices of Kanton St. Gallen
  • Aargau
    • Aarau, Aargau, Switzerland, 4300
      • Private practices of Kanton Aargau
  • Schwyz
    • Altendorf, Schwyz, Switzerland, 8852
      • Private Practice of Kanton Schwyz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: BNP blinded therapy; Clinical treatment without knowledge of BNP levels	Other: Clinical examination
Experimental: BNP guided therapy; Clinical treatment based on clinical examination and BNP-levels	Other: Clinical examination; Other: BNP measurement

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Total medical cost within 3 months	3 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Cost-effectiveness	12 months
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
12-month mortality	12 months
12-month total medical cost	12 months

Collaborators and Investigators

• Sponsor: University Hospital, Basel, Switzerland
• Collaborators: Swiss National Science Foundation
• Investigators: Principal Investigator: Christian Mueller, Prof., University Hospital, Basel, Switzerland

Publications and helpful links

General Publications

• 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.
• 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.

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: January 1, 2004
• Primary Completion (Actual): January 1, 2010
• Study Completion (Actual): January 1, 2011

Study Registration Dates

• First Submitted: August 12, 2005
• First Submitted That Met QC Criteria: August 12, 2005
• First Posted (Estimate): August 15, 2005

Study Record Updates

• Last Update Posted (Estimate): May 29, 2013
• Last Update Submitted That Met QC Criteria: May 28, 2013
• Last Verified: May 1, 2013

More Information

Terms related to this study

• Keywords: heart failure; cost effectiveness; BNP; private practice; Acute dyspnoea
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Dyspnea
• Other Study ID Numbers: BASEL III - Private Practice; PP00B-102853/1; 04.001; 287/03