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

Study Overview
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Brief Summary
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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 Description
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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.

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

Conditions
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Dyspnea

Intervention / Treatment
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* Other: BNP measurement
* Other: Clinical examination


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: BNP blinded therapy<br>Clinical treatment without knowledge of BNP levels | Other: Clinical examination<br> <br> |
| Experimental: BNP guided therapy<br>Clinical treatment based on clinical examination and BNP-levels | Other: BNP measurement<br> <br> Other: Clinical examination<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total medical cost within 3 months |  | 3 months | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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heart failure, cost effectiveness, BNP, private practice, Acute dyspnoea