SCREEN-HFI (SCReening Evaluation of the Evolution of New Heart Failure Intervention Study)

Condition(s) targeted: Heart Failure

Intervention: Spironolactone (Drug); Placebo (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Monash University

Official(s) and/or principal investigator(s):
Henry Krum, MBBS FRACP PhD, Principal Investigator, Affiliation: Monash University / Alfred Hospital

Overall contact:
Henry Krum, MBBS FRACP PhD, Phone: +61 3 9903 0042, Email: henry.krum@med.monash.edu.au

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.

Official title: SCREEN-HFI (SCReening Evaluation of the Evolution of New Heart Failure Intervention Study)

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

Primary outcome:

Effectiveness of Spironolactone in preventing heart failure

Cost effectiveness of Spironolactone prevention

Secondary outcome:

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

Minimum age: 60 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

1. Was recruited to SCREEN-HF

2. Has provided informed consent

Exclusion Criteria:

1. Uncorrected hyperkalaemia

2. eGFR < 30 ml/min

Henry Krum, MBBS FRACP PhD, Phone: +61 3 9903 0042, Email: henry.krum@med.monash.edu.au

Alfred Hospital, Melbourne, Victoria 3004, Australia; Recruiting
Henry Krum, MBBS FRACP PhD, Phone: +61 3 9903 0042, Email: henry.krum@med.monash.edu.au
Henry Krum, MBBS FRACP PhD, Principal Investigator
Chris Reid, A/Professor, Sub-Investigator
Pupalan Iyngkaran, Doctor, Sub-Investigator
Michele McGrady, Doctor, Sub-Investigator

Starting date: September 2008
Ending date: April 2010
Last updated: August 18, 2009