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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE January 16, 2008
First Posted Date  ICMJE January 29, 2008
Last Update Posted Date June 4, 2015
Study Start Date  ICMJE September 2008
Actual Primary Completion Date August 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE
 (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 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE
 (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  ICMJE SCREEN-HFI (SCReening Evaluation of the Evolution of New Heart Failure Intervention Study)
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Heart Failure
Intervention  ICMJE
  • Drug: Spironolactone
    25 mg tablets (placed in capsules for blinding) once daily.
  • Drug: Placebo
    Placebo (lactose in capsules for blinding) once daily
Study Arms  ICMJE
  • Experimental: Group A
    Intervention: Drug: Spironolactone
  • Placebo Comparator: Group B
    Intervention: Drug: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 2, 2015)
20
Original Estimated Enrollment  ICMJE
 (submitted: January 28, 2008)
600
Actual Study Completion Date  ICMJE January 2015
Actual Primary Completion Date August 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 60 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00604006
Other Study ID Numbers  ICMJE CP-02/07
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Prof Henry Krum, Monash University
Study Sponsor  ICMJE Monash University
Collaborators  ICMJE National Heart Foundation, Australia
Investigators  ICMJE
Principal Investigator: Henry Krum, MBBS FRACP PhD Monash University / Alfred Hospital
PRS Account Monash University
Verification Date June 2015

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