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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
Trial website
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

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/NCT00604006