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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/NCT01581827




Registration number
NCT01581827
Ethics application status
Date submitted
12/04/2012
Date registered
20/04/2012
Date last updated
9/04/2018

Titles & IDs
Public title
SCREEN-HFL (SCReening Evaluation of the Evolution of New Heart Failure) - a Longitudinal Study
Scientific title
SCREEN-HFL (SCReening Evaluation of the Evolution of New Heart Failure) - a Longitudinal Study
Secondary ID [1] 0 0
52/09
Universal Trial Number (UTN)
Trial acronym
SHF-L
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
Study population - People at high risk of heart failure (from SCREEN-HF study)
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in NT-proBNP
Timepoint [1] 0 0
baseline and 5 years
Primary outcome [2] 0 0
Change in echocardiogram
Timepoint [2] 0 0
baseline and 5 years
Secondary outcome [1] 0 0
incidence of new heart failure
Timepoint [1] 0 0
baseline and 5 years

Eligibility
Key inclusion criteria
1. Consented and enrolled in the SCREEN-HF study and who agreed to further contact

2. Age = 60 years

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 ischaemic heart disease

- Prior Cerebrovascular Accident (CVA)

- Known valvular heart disease without known LV dysfunction

- Atrial fibrillation

- Treated hypertension, of at least 2 years duration

- Treated Diabetes mellitus, of at least 2 years duration

- Chronic renal impairment (eGFR < 60 ml/min)
Minimum age
60 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Known systolic or diastolic heart failure

2. LV systolic or diastolic dysfunction on echocardiography or other objective imaging
modality (if known).

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
1/01/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2017
Sample size
Target
Accrual to date
Final
3000
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Monash University - Caulfield
Recruitment postcode(s) [1] 0 0
3162 - Caulfield

Funding & Sponsors
Primary sponsor type
Other
Name
Monash University
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
National Health and Medical Research Council, Australia
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Heart failure (when the heart does not pump as well as it used to) is a medical condition
which reduces the quality of life for the sufferers. Approximately 10% of people in western
societies aged over 75 develop heart failure. There has been a shift towards prevention of
this disease and it is hoped that BNP (brain natriuretic peptides) and NT-proBNP (N-terminal
proBNP) will prove to be useful indicators of those at greatest risk. The current study
therefore plans to follow up the 3500 participants at risk of heart failure from the original
SCREEN-HF study.

Participants who are willing to participate will be contacted annually. They will undergo a
short physical exam, will be asked to complete a Quality of Life questionnaire and will have
a blood sample taken. At the end of the study participants will also have an ECG and an
echocardiogram.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01581827
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Henry Krum, MBBS FRACP PhD
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01581827