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

Phase 3

Completed

• Conditions: Heart Failure
• Interventions: Drug: Placebo; Drug: Spironolactone

• Registration Number: NCT00604006
• Lead Sponsor: Monash University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-01-16
• Study First Submitted QC: 2008-01-28
• Study First Posted: 2008-01-29
• Study Start: 2008-09
• Primary Completion: 2014-08
• Study Completion: 2015-01
• Status Verified: 2015-06
• Last Update Submitted: 2015-06-02
• Last Update Posted: 2015-06-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1. Was recruited to SCREEN-HF
2. Has provided informed consent

Exclusion Criteria

1. Uncorrected hyperkalaemia
2. eGFR < 30 ml/min

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group B	Placebo	-
Group A	Spironolactone	-

Primary Outcome Measures

Name	Time	Method
Effectiveness of Spironolactone in preventing heart failure	1 year and 3 year
Cost effectiveness of Spironolactone prevention	3 years

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Alfred Hospital; 🇦🇺 Melbourne, Victoria, Australia