Back to resultsSCREEN-HFI (SCReening Evaluation of the Evolution of New Heart Failure Intervention Study)
Primary Purpose
Heart Failure
Status
Completed
Phase
Phase 3
Locations
Australia
Study Type
Interventional
Intervention
Spironolactone
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Heart Failure focused on measuring Prevention of heart failure in individuals at high risk
Eligibility Criteria
Inclusion Criteria:
- Was recruited to SCREEN-HF
- Has provided informed consent
Exclusion Criteria:
- Uncorrected hyperkalaemia
- eGFR < 30 ml/min
Sites / Locations
- Alfred Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Group A
Group B
Arm Description
Outcomes
Primary Outcome Measures
Effectiveness of Spironolactone in preventing heart failure
Cost effectiveness of Spironolactone prevention
Secondary Outcome Measures
Development of evidence of LV dysfunction, either systolic or diastolic, on echocardiography and/or symptomatic heart failure
Change in 6 minute walk test between the two groups
Change in quality of life between the two groups
Change in left ventricular remodelling parameters
Full Information
NCT ID
NCT00604006
First Posted
January 16, 2008
Last Updated
June 2, 2015
Sponsor
Monash University
Collaborators
National Heart Foundation, Australia
1. Study Identification
Unique Protocol Identification Number
NCT00604006
Brief Title
SCREEN-HFI (SCReening Evaluation of the Evolution of New Heart Failure Intervention Study)
Official Title
SCREEN-HFI (SCReening Evaluation of the Evolution of New Heart Failure Intervention Study)
Study Type
Interventional
2. Study Status
Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
January 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Monash University
Collaborators
National Heart Foundation, Australia
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
Prevention of heart failure in individuals at high risk
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group A
Arm Type
Experimental
Arm Title
Group B
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Spironolactone
Intervention Description
25 mg tablets (placed in capsules for blinding) once daily.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo (lactose in capsules for blinding) once daily
Primary Outcome Measure Information:
Title
Effectiveness of Spironolactone in preventing heart failure
Time Frame
1 year and 3 year
Title
Cost effectiveness of Spironolactone prevention
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Development of evidence of LV dysfunction, either systolic or diastolic, on echocardiography and/or symptomatic heart failure
Time Frame
1 year and 3 year
Title
Change in 6 minute walk test between the two groups
Time Frame
1 year and 3 years
Title
Change in quality of life between the two groups
Time Frame
1 year and 3 year
Title
Change in left ventricular remodelling parameters
Time Frame
1 year and 3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Was recruited to SCREEN-HF
Has provided informed consent
Exclusion Criteria:
Uncorrected hyperkalaemia
eGFR < 30 ml/min
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Henry Krum, MBBS FRACP PhD
Organizational Affiliation
Monash University / Alfred Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Alfred Hospital
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia
12. IPD Sharing Statement
Citations:
PubMed Identifier
33902478
Citation
Campbell DJ, Coller JM, Gong FF, McGrady M, Boffa U, Shiel L, Liew D, Stewart S, Owen AJ, Krum H, Reid CM, Prior DL. Kidney age - chronological age difference (KCD) score provides an age-adapted measure of kidney function. BMC Nephrol. 2021 Apr 26;22(1):152. doi: 10.1186/s12882-021-02324-y.
Results Reference
derived
PubMed Identifier
30057766
Citation
Gong FF, Jelinek MV, Castro JM, Coller JM, McGrady M, Boffa U, Shiel L, Liew D, Wolfe R, Stewart S, Owen AJ, Krum H, Reid CM, Prior DL, Campbell DJ. Risk factors for incident heart failure with preserved or reduced ejection fraction, and valvular heart failure, in a community-based cohort. Open Heart. 2018 Jul 23;5(2):e000782. doi: 10.1136/openhrt-2018-000782. eCollection 2018. Erratum In: Open Heart. 2018 Sep 5;5(2):e000782corr1.
Results Reference
derived
Learn more about this trial
SCREEN-HFI (SCReening Evaluation of the Evolution of New Heart Failure Intervention Study)
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