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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/NCT00604006




Registration number
NCT00604006
Ethics application status
Date submitted
16/01/2008
Date registered
29/01/2008
Date last updated
4/06/2015

Titles & IDs
Public title
SCREEN-HFI (SCReening Evaluation of the Evolution of New Heart Failure Intervention Study)
Scientific title
SCREEN-HFI (SCReening Evaluation of the Evolution of New Heart Failure Intervention Study)
Secondary ID [1] 0 0
CP-02/07
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
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Spironolactone
Treatment: Drugs - Placebo

Experimental: Group A -

Placebo Comparator: Group B -


Treatment: Drugs: Spironolactone
25 mg tablets (placed in capsules for blinding) once daily.

Treatment: Drugs: Placebo
Placebo (lactose in capsules for blinding) once daily
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Effectiveness of Spironolactone in preventing heart failure
Timepoint [1] 0 0
1 year and 3 year
Primary outcome [2] 0 0
Cost effectiveness of Spironolactone prevention
Timepoint [2] 0 0
3 years
Secondary outcome [1] 0 0
Development of evidence of LV dysfunction, either systolic or diastolic, on echocardiography and/or symptomatic heart failure
Timepoint [1] 0 0
1 year and 3 year
Secondary outcome [2] 0 0
Change in 6 minute walk test between the two groups
Timepoint [2] 0 0
1 year and 3 years
Secondary outcome [3] 0 0
Change in quality of life between the two groups
Timepoint [3] 0 0
1 year and 3 year
Secondary outcome [4] 0 0
Change in left ventricular remodelling parameters
Timepoint [4] 0 0
1 year and 3 years

Eligibility
Key inclusion criteria
1. Was recruited to SCREEN-HF

2. Has provided informed consent
Minimum age
60 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Uncorrected hyperkalaemia

2. eGFR < 30 ml/min

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/09/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/01/2015
Sample size
Target
Accrual to date
Final
20
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
Monash University
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
National Heart Foundation, Australia
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Individuals who were a part of the investigators Screen-HF study (NCT00400257) whose BNP
level are in the top quintile will be offered participation in this study. Participants will
be randomised to receive either spironolactone or placebo for three years. Participants will
then be monitored for indications of heart failure. It is anticipated that the medication
will reduce the development of heart failure in this group.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00604006
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/NCT00604006