SCREEN-HFI (SCReening Evaluation of the Evolution of New Heart Failure Intervention Study)
Individuals who were apart 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 two years. Participants will then be monitored for indications of heart failure. It is anticipated that the medication will reduce the development of heart...
Brief Summary
Official Title: “SCREEN-HFI (SCReening Evaluation of the Evolution of New Heart Failure Intervention Study)”
Individuals who were apart 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 two 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.
- Study Type: Interventional
- Study Design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention
- Study Primary Completion Date: April 2015
Intervention(s) in this Clinical Trial
- Drug: Spironolactone
- 25 mg tablets (placed in capsules for blinding) once daily.
- Drug: Placebo
- Placebo (lactose in capsules for blinding) once daily
Arms, Groups and Cohorts in this Clinical Trial
- Experimental: Group A
- Placebo Comparator: Group B
Outcome Measures for this Clinical Trial
Primary Measures
- Effectiveness of Spironolactone in preventing heart failure
- Time Frame: 1 year and 2 year
Safety Issue?: No
- Time Frame: 1 year and 2 year
- Cost effectiveness of Spironolactone prevention
- Time Frame: 2 years
Safety Issue?: No
- Time Frame: 2 years
Secondary Measures
- Development of evidence of LV dysfunction, either systolic or diastolic, on echocardiography and/or symptomatic heart failure
- Time Frame: 1 year and 2 year
Safety Issue?: No
- Time Frame: 1 year and 2 year
- Change in 6 minute walk test between the two groups
- Time Frame: 1 year and 2 years
Safety Issue?: No
- Time Frame: 1 year and 2 years
- Change in quality of life between the two groups
- Time Frame: 1 year and 2 year
Safety Issue?: No
- Time Frame: 1 year and 2 year
- Change in left ventricular remodelling parameters
- Time Frame: 1 year and 2 years
Safety Issue?: No
- Time Frame: 1 year and 2 years
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- 1. Was recruited to SCREEN-HF
- 2. Has provided informed consent
Exclusion Criteria:
- 1. Uncorrected hyperkalaemia
- 2. eGFR < 30 ml/min
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 60 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers
Clinical Trial Investigator Information
Lead Investigator: Monash University Other
Overall Clinical Trial Officials and Contacts
Henry Krum, MBBS FRACP PhD Principal Investigator Monash University / Alfred Hospital
Overall Contact: Henry Krum, MBBS FRACP PhD +61 3 9903 0042 henry.krum@med.monash.edu.au
Additional Information
Information obtained from ClinicalTrials.gov on February 12, 2012
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00604006
Study ID Number: CP-02/07
ClinicalTrials.gov Identifier: NCT00604006
Health Authority: Australia: Human Research Ethics Committee
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00604006
