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

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00604006
• Other study ID #: CP-02/07
• Status: Completed
• Phase: Phase 3
• First received: January 16, 2008
• Last updated: June 2, 2015
• Start date: September 2008
• Est. completion date: January 2015

Study information

• Verified date: June 2015
• Source: Monash University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Human Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: January 2015
• Est. primary completion date: August 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 60 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Heart Failure

Intervention

Drug:
• Spironolactone
25 mg tablets (placed in capsules for blinding) once daily.
• Placebo
Placebo (lactose in capsules for blinding) once daily

Locations

Country	Name	City	State
Australia	Alfred Hospital	Melbourne	Victoria

Sponsors (2)

Lead Sponsor	Collaborator
Monash University	National Heart Foundation, Australia

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effectiveness of Spironolactone in preventing heart failure		1 year and 3 year	No
Primary	Cost effectiveness of Spironolactone prevention		3 years	No
Secondary	Development of evidence of LV dysfunction, either systolic or diastolic, on echocardiography and/or symptomatic heart failure		1 year and 3 year	No
Secondary	Change in 6 minute walk test between the two groups		1 year and 3 years	No
Secondary	Change in quality of life between the two groups		1 year and 3 year	No
Secondary	Change in left ventricular remodelling parameters		1 year and 3 years	No