Ignite Creation Date:
2024-05-05 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00130611
Status:
COMPLETED
Last Update Posted:
2013-05-29
First Post:
2005-08-12
Brief Title:
B-type Natriuretic Peptide for Acute Shortness of Breath EvaLuation BASEL Study - Private Practice
Sponsor:
University Hospital Basel Switzerland
Organization:
University Hospital Basel Switzerland
Study Overview
Official Title:
B-type Natriuretic Peptide for Acute Shortness of Breath EvaLuation BASEL Study - Private Practice
Status:
COMPLETED
Status Verified Date:
2013-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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:
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 104 billion In addition there are nearly 15 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 11 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
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 11 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 28703 | None | None | None |
| PP00B-1028531 | None | None | None |
| 04001 | None | None | None |