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

Information source: Monash University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Heart Failure

Intervention: Spironolactone (Drug); Placebo (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Monash University

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

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention

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

Eligibility

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

Locations and Contacts

Alfred Hospital, Melbourne, Victoria 3004, Australia
Additional Information

Starting date: September 2008
Last updated: June 2, 2015

Page last updated: August 23, 2015

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