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B-Type Natriuretic Peptide for Acute Shortness of Breath EvaLuation (BASEL) Study - Private Practice
This study is ongoing, but not recruiting participants.
Sponsors and Collaborators: University Hospital, Basel, Switzerland
Swiss National Science Foundation
Information provided by: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT00130611
  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. 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.


Condition Intervention Phase
Dyspnea
Procedure: BNP guided diagnostics and initial therapy
Phase IV

MedlinePlus related topics: Breathing Problems Heart Failure
Drug Information available for: Nesiritide
U.S. FDA Resources
Study Type: Interventional
Study Design: Diagnostic, Randomized, Single Blind, Active Control, Parallel Assignment, Efficacy Study
Official Title: B-Type Natriuretic Peptide for Acute Shortness of Breath EvaLuation (BASEL) Study - Private Practice

Further study details as provided by University Hospital, Basel, Switzerland:

Primary Outcome Measures:
  • Total medical cost within 3 months

Secondary Outcome Measures:
  • Hospitalisation
  • Time interval to the initiation of the most appropriate
  • therapy
  • 3-month mortality
  • Dyspnea (New York Heart Association [NYHA]) at 3 months
  • 12-month mortality
  • 12-month total medical cost
  • Cost-effectiveness

Estimated Enrollment: 250
Study Start Date: January 2004
Estimated Study Completion Date: February 2008
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00130611

Locations
Germany
Private practices of Baden-Wuertemberg
Freiburg, Germany
Switzerland
Private Practices of Kanton Basel Stadt
Basel, Switzerland, 4000
Private Practices of Kanton Basel-Landschaft
Basel-Landschaft, Switzerland, 4100
Private Practices of Kanton Graubünden
Chur, Switzerland, 7500
Private practices in Kanton Obwalden
Sarnen, Switzerland, 6060
Private practices of Kanton Solothurn
Solothurn, Switzerland, 4500
Private practices of Kanton St. Gallen
St. Gallen, Switzerland
Switzerland, Aargau
Private practices of Kanton Aargau
Aarau, Aargau, Switzerland, 4300
Switzerland, Schwyz
Private Practice of Kanton Schwyz
Altendorf, Schwyz, Switzerland, 8852
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Swiss National Science Foundation
Investigators
Principal Investigator: Christian Mueller, Prof. University Hospital Basel
  More Information

Related Info  This link exits the ClinicalTrials.gov site

Publications:
Study ID Numbers: BASEL III - Private Practice, PP00B-102853/1, 04.001, 287/03
Study First Received: August 12, 2005
Last Updated: June 25, 2007
ClinicalTrials.gov Identifier: NCT00130611  
Health Authority: Switzerland: Swissmedic

Keywords provided by University Hospital, Basel, Switzerland:
heart failure
cost effectiveness
BNP
private practice
Acute dyspnoea

Study placed in the following topic categories:
Natriuretic Peptide, Brain
Signs and Symptoms
Heart Failure
Respiratory Tract Diseases
Respiration Disorders
Signs and Symptoms, Respiratory
Dyspnea

Additional relevant MeSH terms:
Natriuretic Agents
Therapeutic Uses
Physiological Effects of Drugs
Cardiovascular Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009