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
  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
Other: BNP measurement
Other: Clinical examination
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Diagnostic
Official Title: B-type Natriuretic Peptide for Acute Shortness of Breath EvaLuation (BASEL) Study - Private Practice

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Total medical cost within 3 months [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 250
Study Start Date: January 2004
Study Completion Date: January 2011
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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: BNP measurement Other: Clinical examination

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 Aargau
Aarau, Aargau, Switzerland, 4300
Private Practice of Kanton Schwyz
Altendorf, Schwyz, Switzerland, 8852
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
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Swiss National Science Foundation
Investigators
Principal Investigator: Christian Mueller, Prof. University Hospital, Basel, Switzerland
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT00130611     History of Changes
Other Study ID Numbers: BASEL III - Private Practice, PP00B-102853/1, 04.001, 287/03
Study First Received: August 12, 2005
Last Updated: May 28, 2013
Health Authority: Switzerland: Swissmedic

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

Additional relevant MeSH terms:
Dyspnea
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms
Signs and Symptoms, Respiratory
Natriuretic Peptide, Brain
Cardiovascular Agents
Natriuretic Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014