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Tracking Information | |||||
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First Received Date † | November 15, 2006 | ||||
Last Updated Date | January 28, 2009 | ||||
Start Date † | May 2007 | ||||
Current Primary Outcome Measures † | |||||
Original Primary Outcome Measures † | |||||
Change History | Complete list of historical versions of study NCT00400257 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures † | |||||
Original Secondary Outcome Measures † | |||||
Descriptive Information | |||||
Brief Title † | Screening Evaluation of the Evolution of New Heart Failure (SCREEN-HF) | ||||
Official Title † | SCREEN-HF (Screening Evaluation of the Evolution of New Heart Failure) | ||||
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 natriuetic peptide (BNP) in doing this. |
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Detailed Description | Measuring Brain natriuetic peptide (BNP) can give us useful information about a persons heart function in patients with symptoms such as shortness of breath. This is because BNP levels rise when the heart is under pressure as it is in people with heart disease. However, we don't 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 and we estimate that 10,000 HBA members will need to be contact by letter and invited to screen for this study to achieve the required 3500. Participants will undergo a routine blood test which will include measuring NTproBNP. Only participants in whom BNP 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. |
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Study Phase | |||||
Study Type † | Observational | ||||
Study Design † | Cohort, Prospective | ||||
Condition † | Heart Failure | ||||
Intervention † | Behavioral: Early detection of heart failure | ||||
Study Arms / Comparison Groups | People at high risk of heart failure. | ||||
Publications * | |||||
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |||||
Recruitment Status † | Recruiting | ||||
Enrollment † | 3500 | ||||
Estimated Completion Date | August 2009 | ||||
Primary Completion Date | |||||
Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
Use of such medications for approved indications such as hypertension, post-MI management (without known LV dysfunction) or for diabetic nephropathy is permitted. |
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Gender | Both | ||||
Ages | 60 Years and older | ||||
Accepts Healthy Volunteers | Yes | ||||
Contacts †† |
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Location Countries † | Australia | ||||
Expanded Access Status | |||||
Administrative Information | |||||
NCT ID † | NCT00400257 | ||||
Responsible Party | Bert Boffa, HBA | ||||
Secondary IDs †† | |||||
Study Sponsor † | The Alfred | ||||
Collaborators †† | HBA | ||||
Investigators † |
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Information Provided By | The Alfred | ||||
Verification Date | January 2009 | ||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |