We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Heart Failure Drug: Spironolactone Drug: Placebo Phase 3

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: SCREEN-HFI (SCReening Evaluation of the Evolution of New Heart Failure Intervention Study)
Study Start Date : September 2008
Actual Primary Completion Date : August 2014
Actual Study Completion Date : January 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Group A Drug: Spironolactone
25 mg tablets (placed in capsules for blinding) once daily.
Placebo Comparator: Group B Drug: Placebo
Placebo (lactose in capsules for blinding) once daily


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Effectiveness of Spironolactone in preventing heart failure [ Time Frame: 1 year and 3 year ]
  2. Cost effectiveness of Spironolactone prevention [ Time Frame: 3 years ]

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

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. Uncorrected hyperkalaemia
  2. eGFR < 30 ml/min
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00604006


Locations
Layout table for location information
Australia, Victoria
Alfred Hospital
Melbourne, Victoria, Australia, 3004
Sponsors and Collaborators
Monash University
National Heart Foundation, Australia
Investigators
Layout table for investigator information
Principal Investigator: Henry Krum, MBBS FRACP PhD Monash University / Alfred Hospital
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: Prof Henry Krum, Monash University
ClinicalTrials.gov Identifier: NCT00604006    
Other Study ID Numbers: CP-02/07
First Posted: January 29, 2008    Key Record Dates
Last Update Posted: June 4, 2015
Last Verified: June 2015
Keywords provided by Prof Henry Krum, Monash University:
Prevention of heart failure in individuals at high risk
Additional relevant MeSH terms:
Layout table for MeSH terms
Heart Failure
Heart Diseases
Cardiovascular Diseases
Spironolactone
Mineralocorticoid Receptor Antagonists
Hormone Antagonists
 Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Diuretics, Potassium Sparing
Diuretics
Natriuretic Agents