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: Prevention, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study

Study Primary Completion Date: April 2010

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

Primary Measures

• Effectiveness of Spironolactone in preventing heart failure
  • Time Frame: 1 year and 2 year
    Safety Issue?: No
• cost effectiveness of Spironolactone prevention
  • Time Frame: 2 years
    Safety Issue?: No

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
• Change in 6 minute walk test between the two groups
  • Time Frame: 1 year and 2 years
    Safety Issue?: No
• Change in quality of life between the two groups
  • Time Frame: 1 year and 2 year
    Safety Issue?: No
• Change in left ventricular remodelling parameters
  • Time Frame: 1 year and 2 years
    Safety Issue?: No

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

Lead Sponsor: Monash University

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

Information obtained from ClinicalTrials.gov on July 02, 2009

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