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

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

January 16, 2008
January 29, 2008
June 4, 2015
September 2008
August 2014   (Final data collection date for primary outcome measure)
  • Effectiveness of Spironolactone in preventing heart failure [ Time Frame: 1 year and 3 year ]
  • Cost effectiveness of Spironolactone prevention [ Time Frame: 3 years ]
  • Effectiveness of Spironolactone in preventing heart failure [ Time Frame: 1 year and 2 year ]
  • Cost effectiveness of Spironolactone prevention [ Time Frame: 2 years ]
Complete list of historical versions of study NCT00604006 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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 ]
Not Provided
Not Provided
 
SCREEN-HFI (SCReening Evaluation of the Evolution of New Heart Failure Intervention Study)
SCREEN-HFI (SCReening Evaluation of the Evolution of New Heart Failure Intervention Study)
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Heart Failure
  • Drug: Spironolactone
    25 mg tablets (placed in capsules for blinding) once daily.
  • Drug: Placebo
    Placebo (lactose in capsules for blinding) once daily
  • Experimental: Group A
    Intervention: Drug: Spironolactone
  • Placebo Comparator: Group B
    Intervention: Drug: Placebo
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
600
January 2015
August 2014   (Final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  1. Uncorrected hyperkalaemia
  2. eGFR < 30 ml/min
Sexes Eligible for Study: All
60 Years and older   (Adult, Older Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Australia
 
 
NCT00604006
CP-02/07
No
Not Provided
Not Provided
Prof Henry Krum, Monash University
Monash University
National Heart Foundation, Australia
Principal Investigator: Henry Krum, MBBS FRACP PhD Monash University / Alfred Hospital
Monash University
June 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP