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

• ClinicalTrials.gov Identifier: NCT00604006
• Recruitment Status: Completed
• First Posted: January 29, 2008
• Last Update Posted: June 4, 2015
• Sponsor: Monash University
• Collaborator: National Heart Foundation, Australia
• Information provided by (Responsible Party): Prof Henry Krum, Monash University

Tracking Information

• First Submitted Date: January 16, 2008
• First Posted Date: January 29, 2008
• Last Update Posted Date: June 4, 2015
• Study Start Date: September 2008
• Actual Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: March 8, 2012)

• Effectiveness of Spironolactone in preventing heart failure [ Time Frame: 1 year and 3 year ]
• Cost effectiveness of Spironolactone prevention [ Time Frame: 3 years ]

Original Primary Outcome Measures (submitted: January 28, 2008)

• Effectiveness of Spironolactone in preventing heart failure [ Time Frame: 1 year and 2 year ]
• cost effectiveness of Spironolactone prevention [ Time Frame: 2 years ]

Current Secondary Outcome Measures (submitted: March 8, 2012)

• Development of evidence of LV dysfunction, either systolic or diastolic, on echocardiography and/or symptomatic heart failure [ Time Frame: 1 year and 3 year ]
• Change in 6 minute walk test between the two groups [ Time Frame: 1 year and 3 years ]
• Change in quality of life between the two groups [ Time Frame: 1 year and 3 year ]
• Change in left ventricular remodelling parameters [ Time Frame: 1 year and 3 years ]

Original Secondary Outcome Measures (submitted: January 28, 2008)

• Development of evidence of LV dysfunction, either systolic or diastolic, on echocardiography and/or symptomatic heart failure [ Time Frame: 1 year and 2 year ]
• Change in 6 minute walk test between the two groups [ Time Frame: 1 year and 2 years ]
• Change in quality of life between the two groups [ Time Frame: 1 year and 2 year ]
• Change in left ventricular remodelling parameters [ Time Frame: 1 year and 2 years ]

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: SCREEN-HFI (SCReening Evaluation of the Evolution of New Heart Failure Intervention Study)
• Official Title: SCREEN-HFI (SCReening Evaluation of the Evolution of New Heart Failure Intervention Study)
• 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 Provided
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Investigator, Outcomes Assessor); Primary Purpose: Prevention
• Condition: Heart Failure

Intervention

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

Study Arms

• Experimental: Group A
  Intervention: Drug: Spironolactone
• Placebo Comparator: Group B
  Intervention: Drug: Placebo

Publications *

• Campbell DJ, Coller JM, Gong FF, McGrady M, Boffa U, Shiel L, Liew D, Stewart S, Owen AJ, Krum H, Reid CM, Prior DL. Kidney age - chronological age difference (KCD) score provides an age-adapted measure of kidney function. BMC Nephrol. 2021 Apr 26;22(1):152. doi: 10.1186/s12882-021-02324-y.
• Gong FF, Jelinek MV, Castro JM, Coller JM, McGrady M, Boffa U, Shiel L, Liew D, Wolfe R, Stewart S, Owen AJ, Krum H, Reid CM, Prior DL, Campbell DJ. Risk factors for incident heart failure with preserved or reduced ejection fraction, and valvular heart failure, in a community-based cohort. Open Heart. 2018 Jul 23;5(2):e000782. doi: 10.1136/openhrt-2018-000782. eCollection 2018. Erratum in: Open Heart. 2018 Sep 5;5(2):e000782corr1.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: June 2, 2015): 20
• Original Estimated Enrollment (submitted: January 28, 2008): 600
• Actual Study Completion Date: January 2015
• Actual Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 60 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Australia

Administrative Information

• NCT Number: NCT00604006
• Other Study ID Numbers: CP-02/07
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Prof Henry Krum, Monash University
• Study Sponsor: Monash University
• Collaborators: National Heart Foundation, Australia

Investigators

• Principal Investigator: Henry Krum, MBBS FRACP PhD; Monash University / Alfred Hospital

• PRS Account: Monash University
• Verification Date: June 2015