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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00400257
Registration number
NCT00400257
Ethics application status
Date submitted
15/11/2006
Date registered
16/11/2006
Date last updated
1/06/2016
Titles & IDs
Public title
Screening Evaluation of the Evolution of New Heart Failure (SCREEN-HF)
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Scientific title
SCREEN-HF (Screening Evaluation of the Evolution of New Heart Failure)
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Secondary ID [1]
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CP-04/06
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Heart Failure
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Condition category
Condition code
Cardiovascular
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Coronary heart disease
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Cardiovascular
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Other cardiovascular diseases
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Behaviour - Early detection of heart failure
1 - People at high risk of heart failure.
Behaviour: Early detection of heart failure
Early detection of heart failure
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Intervention code [1]
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Behaviour
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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To assess the effectiveness of BNP in determining Heart Failure in people not previously diagnosed with the condition.
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Assessment method [1]
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Timepoint [1]
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at visit 2
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Eligibility
Key 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
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Minimum age
60
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key 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)
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/05/2007
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/12/2015
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Sample size
Target
3500
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Alfred Hospital - Melbourne
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Recruitment postcode(s) [1]
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3004 - Melbourne
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Funding & Sponsors
Primary sponsor type
Other
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Name
Ingrid Hopper
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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HBA
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00400257
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Henry Krum, Professor
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Address
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Monash University / Alfred Hospital
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00400257
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