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

This study has been completed.
Sponsor:
Collaborator:
Swiss National Science Foundation
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier:
NCT00130611
First received: August 12, 2005
Last updated: May 28, 2013
Last verified: May 2013

August 12, 2005
May 28, 2013
January 2004
January 2010   (final data collection date for primary outcome measure)
Total medical cost within 3 months [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Total medical cost within 3 months
Complete list of historical versions of study NCT00130611 on ClinicalTrials.gov Archive Site
  • Hospitalisation [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  • Time interval to the initiation of the most appropriate therapy [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  • therapy [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  • 3-month mortality [ Time Frame: 3 month ] [ Designated as safety issue: No ]
  • Dyspnea (New York Heart Association [NYHA]) at 3 months [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • 12-month mortality [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • 12-month total medical cost [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Cost-effectiveness [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • - 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
Not Provided
Not Provided
 
B-type Natriuretic Peptide for Acute Shortness of Breath EvaLuation (BASEL) Study - Private Practice
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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Diagnostic
Dyspnea
  • Other: BNP measurement
  • Other: Clinical examination
  • Placebo Comparator: BNP blinded therapy
    Clinical treatment without knowledge of BNP levels
    Intervention: Other: Clinical examination
  • Experimental: BNP guided therapy
    Clinical treatment based on clinical examination and BNP-levels
    Interventions:
    • Other: BNP measurement
    • Other: Clinical examination

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
250
January 2011
January 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany,   Switzerland
 
NCT00130611
BASEL III - Private Practice, PP00B-102853/1, 04.001, 287/03
Not Provided
University Hospital, Basel, Switzerland
University Hospital, Basel, Switzerland
Swiss National Science Foundation
Principal Investigator: Christian Mueller, Prof. University Hospital, Basel, Switzerland
University Hospital, Basel, Switzerland
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP