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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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 Summary:

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.

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Sponsor: University Hospital, Basel, Switzerland

Current Primary Outcome: Total medical cost within 3 months [ Time Frame: 3 months ]

Original Primary Outcome: Total medical cost within 3 months

Current Secondary Outcome:

  • Hospitalisation [ Time Frame: 1 month ]
  • Time interval to the initiation of the most appropriate therapy [ Time Frame: 1 month ]
  • therapy [ Time Frame: 1 month ]
  • 3-month mortality [ Time Frame: 3 month ]
  • Dyspnea (New York Heart Association [NYHA]) at 3 months [ Time Frame: 3 months ]
  • 12-month mortality [ Time Frame: 12 months ]
  • 12-month total medical cost [ Time Frame: 12 months ]
  • Cost-effectiveness [ Time Frame: 12 months ]


Original Secondary Outcome:

  • - 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


Information By: University Hospital, Basel, Switzerland

Dates:
Date Received: August 12, 2005
Date Started: January 2004
Date Completion:
Last Updated: May 28, 2013
Last Verified: May 2013