Heart Failure
Conditions
Keywords
Prevention of heart failure in individuals at high risk
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.
Interventions
DRUGSpironolactone
25 mg tablets (placed in capsules for blinding) once daily.
DRUGPlacebo
Placebo (lactose in capsules for blinding) once daily
Sponsors
National Heart Foundation, Australia
Monash University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Was recruited to SCREEN-HF 2. Has provided informed consent
Exclusion criteria
1. Uncorrected hyperkalaemia 2. eGFR \< 30 ml/min
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Effectiveness of Spironolactone in preventing heart failure | 1 year and 3 year |
| Cost effectiveness of Spironolactone prevention | 3 years |
Secondary
| Measure | Time frame |
|---|---|
| Development of evidence of LV dysfunction, either systolic or diastolic, on echocardiography and/or symptomatic heart failure | 1 year and 3 year |
| Change in 6 minute walk test between the two groups | 1 year and 3 years |
| Change in quality of life between the two groups | 1 year and 3 year |
| Change in left ventricular remodelling parameters | 1 year and 3 years |
Countries
Australia
Outcome results
None listed