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Clinical Trial: B-Type Natriuretic Peptide for Acute Shortness of Breath EvaLuation (BASEL) Study - Private Practice
This study is currently recruiting patients.
Verified by University Hospital, Basel, Switzerland August 2005
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Purpose
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. 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.
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.
| Condition | Intervention | Phase |
|---|---|---|
| Acute dyspnoea | Procedure: BNP guided diagnostics and initial therapy | Phase IV |
MedlinePlus related topics: Breathing Problems
Study Type: Interventional
Study Design: Diagnostic, Randomized, Single Blind, Active Control, Parallel Assignment, Efficacy Study
Secondary Outcomes: - 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
Expected Total Enrollment: 250
Study start: January 2004; Expected completion: June 2008
Last follow-up: December 2007; Data entry closure: March 2008
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, we 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 our 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 our attempts to reduce cost of health care to society without reducing (but possibly increasing) the quality of health care.
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
Location and Contact Information
Kirsten Laule-Kilian 0041 61 265 25 25 laulek@uhbs.ch
Germany
Private practices of Baden-Wuertemberg, Freiburg, Germany; Recruiting
Andrea Fräulin, Dr., Sub-Investigator
Helmut Gekeler, Dr., Sub-Investigator
Lothar Schlageter, Dr., Sub-Investigator
Switzerland
Private Practices of Kanton Basel-Stadt, Basel, 4000, Switzerland; Recruiting
Klaus Bally, Dr., Sub-Investigator
Laurent Dukas, Dr., Sub-Investigator
Michael Gonon, Dr., Sub-Investigator
Alexander Haegeli, Dr., Sub-Investigator
Ruedi Isler, Dr., Sub-Investigator
Stefan Lehmann, Dr., Sub-Investigator
Dominik Marti, Dr., Sub-Investigator
Urs Niederoest, Dr., Sub-Investigator
Reto Pinoesch, Dr., Sub-Investigator
Andreas Schlumpf, Dr., Sub-Investigator
Michael Schwarz, Dr., Sub-Investigator
Andreas Sokhegyi, Dr., Sub-Investigator
Balthasar Staehelin, Dr., Sub-Investigator
Cosette Stoerkle-Buser, Dr., Sub-Investigator
Philipp Tschopp, Dr., Sub-Investigator
Peter Tschudi, Dr., Sub-Investigator
Regula Zimak-Ryffel, Dr., Sub-Investigator
Private Practices of Kanton Basel-Landschaft, Basel-Landschaft, 4100, Switzerland; Recruiting
Claus Kopp, Dr., Sub-Investigator
Peter Sigg, Dr., Sub-Investigator
Martin Tschan, Dr., Sub-Investigator
Heini Wacker, Dr., Sub-Investigator
Private Practices of Kanton Graubünden, Chur, 7500, Switzerland; Recruiting
Lueder Kaestner, Dr., Sub-Investigator
Private practices in Kanton Obwalden, Sarnen, 6060, Switzerland; Recruiting
Therese Geiger-Burch, Dr., Sub-Investigator
Thomas Müller, Dr., Sub-Investigator
Private practices of Kanton Solothurn, Solothurn, 4500, Switzerland; Recruiting
Monika Büttiker, Dr., Sub-Investigator
Private practices of Kanton St. Gallen, St. Gallen, Switzerland; Recruiting
Jean-Jacques Brocard, Dr., Sub-Investigator
Ruedi Elsaesser, Dr., Sub-Investigator
Telemachos Hatziisaak, Dr., Sub-Investigator
Urs Keller, Dr., Sub-Investigator
Heidi Martin-Braschler, Dr., Sub-Investigator
Ruedi Stahlberger, Dr., Sub-Investigator
Werner Sulser, Dr., Sub-Investigator
Switzerland, Aargau
Private practices of Kanton Aargau, AARAU, Aargau, 4300, Switzerland; Recruiting
Guido Casagrande, Dr., Sub-Investigator
Christian Mueller, Prof., Principal Investigator, University Hospital Basel
More Information
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.
Last Updated: August 12, 2005
Record first received: August 12, 2005
ClinicalTrials.gov Identifier: NCT00130611
Health Authority: Switzerland: Swissmedic
ClinicalTrials.gov processed this record on 2005-08-23

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