Ignite Creation Date:
2024-05-05 @ 5:12 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00400257
Status:
COMPLETED
Last Update Posted:
2016-06-01
First Post:
2006-11-15
Brief Title:
Screening Evaluation of the Evolution of New Heart Failure SCREEN-HF
Sponsor:
Ingrid Hopper
Organization:
The Alfred
Study Overview
Official Title:
SCREEN-HF Screening Evaluation of the Evolution of New Heart Failure
Status:
COMPLETED
Status Verified Date:
2016-05
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:
The investigators are hoping to identify early heart failure in patients who do not have symptoms as yet and at the same time assess the usefulness of Brain natriuretic peptide BNP in doing this
Detailed Description:
Measuring Brain natriuretic peptide BNP and N-terminal proBNP NT-proBNPand can give us useful information about a persons heart function in patients with symptoms such as shortness of breath This is because BNPNT-proBNP levels rise when the heart is under pressure as it is in people with heart disease However we dont know if this is a useful test to do in people who are at a high risk of developing heart disease but who have no symptoms and have not been diagnosed with any heart problems
In this study we hope to recruit 3500 participants This study is being run in conjunction with HBA recently renamed Bupa and we estimate that 10000 HBA members will need to be contacted by letter and invited to screen for this study to achieve the required 3500 protocol amended to include people who meet the entry criteria but who are not insured through HBA
This protocol has been amended to allow us to invite 50 participants with the lowest NT-proBNP levels to also continue in the study and have blood tests an ECG and echocardiography as described below
Participants will undergo a routine blood test which will include measuring NT-proBNP Only participants in whom NT-proBNP is elevated will undergo additional blood tests for cardiac markers an ECG and echocardiography to determine if there is any indication that they do have heart disease even though they have not been diagnosed and are not symptomatic
In this study we hope to recruit 3500 participants This study is being run in conjunction with HBA recently renamed Bupa and we estimate that 10000 HBA members will need to be contacted by letter and invited to screen for this study to achieve the required 3500 protocol amended to include people who meet the entry criteria but who are not insured through HBA
This protocol has been amended to allow us to invite 50 participants with the lowest NT-proBNP levels to also continue in the study and have blood tests an ECG and echocardiography as described below
Participants will undergo a routine blood test which will include measuring NT-proBNP Only participants in whom NT-proBNP is elevated will undergo additional blood tests for cardiac markers an ECG and echocardiography to determine if there is any indication that they do have heart disease even though they have not been diagnosed and are not symptomatic
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