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Screening Evaluation of the Evolution of New Heart Failure (SCREEN-HF)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00400257
Recruitment Status : Completed
First Posted : November 16, 2006
Last Update Posted : June 1, 2016
Information provided by (Responsible Party):
Ingrid Hopper, The Alfred

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.

Condition or disease Intervention/treatment
Heart Failure Behavioral: Early detection of heart failure

Detailed Description:

Measuring Brain natriuretic peptide (BNP) and N-terminal proBNP (NT-proBNP)and can give us useful information about a persons heart function in patients with symptoms such as shortness of breath. This is because BNP/NT-proBNP 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 (recently renamed Bupa) and we estimate that 10,000 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.

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Study Type : Observational
Estimated Enrollment : 3500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: SCREEN-HF (Screening Evaluation of the Evolution of New Heart Failure)
Study Start Date : May 2007
Actual Primary Completion Date : January 2010
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Group/Cohort Intervention/treatment
People at high risk of heart failure.
Behavioral: Early detection of heart failure
Early detection of heart failure

Primary Outcome Measures :
  1. To assess the effectiveness of BNP in determining Heart Failure in people not previously diagnosed with the condition. [ Time Frame: at visit 2 ]

Biospecimen Retention:   Samples Without DNA
Blood samples

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
People at high risk of heart failure.

Inclusion Criteria:

  1. Age ≥60 years
  2. Have been insured with HBA for 12 months or longer (Protocol amended to remove this criteria and allow enrollment of the general public)
  3. Subjects at high-risk of subsequent development of heart failure; comprising at least one of:

    • Prior myocardial infarction (MI) without known left ventricular (LV) dysfunction
    • Current active ischemic heart disease
    • Prior Cerebrovascular Accident (CVA)
    • Known valvular heart disease without known LV dysfunction
    • Atrial fibrillation
    • Ventricular arrhythmia resulting in syncope or pre-syncope (protocol amended to remove this entry criteria)
    • Treated hypertension, of at least 2 years duration
    • Treated Diabetes mellitus, of at least 2 years duration
    • Estimated Glomerular Filtration Rate (eGFR) <50ml/min

Exclusion Criteria:

  1. Known systolic or diastolic heart failure
  2. Symptoms suggestive of current heart failure. (protocol amended to remove this criteria)
  3. LV systolic or diastolic dysfunction on echocardiography or other objective imaging modality.
  4. Medications for treatment of heart failure such as ACE inhibitors, angiotensin receptor blockers (ARBs), beta-blockers or aldosterone antagonists. Use of such medications for approved indications such as hypertension, post-MI management (without known LV dysfunction) or for diabetic nephropathy is permitted. (protocol amended to remove this criteria)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00400257

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Australia, Victoria
Alfred Hospital
Melbourne, Victoria, Australia, 3004
Sponsors and Collaborators
Ingrid Hopper
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Principal Investigator: Henry Krum, Professor Monash University / Alfred Hospital
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Ingrid Hopper, Dr Ingrid Hopper, The Alfred Identifier: NCT00400257    
Other Study ID Numbers: CP-04/06
First Posted: November 16, 2006    Key Record Dates
Last Update Posted: June 1, 2016
Last Verified: May 2016
Keywords provided by Ingrid Hopper, The Alfred:
Heart Failure
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases