Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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)
Scientific title
SCREEN-HF (Screening Evaluation of the Evolution of New Heart Failure)
Secondary ID [1] 0 0
CP-04/06
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Heart Failure 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
BEHAVIORAL - Early detection of heart failure

1 - People at high risk of heart failure.


BEHAVIORAL: Early detection of heart failure
Early detection of heart failure
Intervention code [1] 0 0
BEHAVIORAL
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
To assess the effectiveness of BNP in determining Heart Failure in people not previously diagnosed with the condition.
Timepoint [1] 0 0
at visit 2

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
Minimum age
60 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
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)

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/05/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2015
Sample size
Target
3500
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Alfred Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
Ingrid Hopper
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
HBA
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Henry Krum, Professor
Address 0 0
Monash University / Alfred Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00400257