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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00604006
First Posted: January 29, 2008
Last Update Posted: June 4, 2015
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.
Collaborator:
National Heart Foundation, Australia
Information provided by (Responsible Party):
Prof Henry Krum, Monash University
  Purpose
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 Intervention Phase
Heart Failure Drug: Spironolactone Drug: Placebo Phase 3

Study Type: Interventional
Study Design: 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)

Resource links provided by NLM:


Further study details as provided by Prof Henry Krum, Monash University:

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

Secondary Outcome Measures:
  • 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 ]

Enrollment: 20
Study Start Date: September 2008
Study Completion Date: January 2015
Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Senior)
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
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
Australia, Victoria
Alfred Hospital
Melbourne, Victoria, Australia, 3004
Sponsors and Collaborators
Monash University
National Heart Foundation, Australia
Investigators
Principal Investigator: Henry Krum, MBBS FRACP PhD Monash University / Alfred Hospital
  More Information

Responsible Party: Prof Henry Krum, Monash University
ClinicalTrials.gov Identifier: NCT00604006     History of Changes
Other Study ID Numbers: CP-02/07
First Submitted: January 16, 2008
First Posted: January 29, 2008
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:
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