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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Monash University
Sponsor:
Collaborator:
National Heart Foundation, Australia
Information provided by (Responsible Party):
Prof Henry Krum, Monash University
ClinicalTrials.gov Identifier:
NCT00604006
First received: January 16, 2008
Last updated: March 6, 2014
Last verified: March 2014
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 Monash University:

Primary Outcome Measures:
  • Effectiveness of Spironolactone in preventing heart failure [ Time Frame: 1 year and 3 year ] [ Designated as safety issue: No ]
  • Cost effectiveness of Spironolactone prevention [ Time Frame: 3 years ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]
  • Change in 6 minute walk test between the two groups [ Time Frame: 1 year and 3 years ] [ Designated as safety issue: No ]
  • Change in quality of life between the two groups [ Time Frame: 1 year and 3 year ] [ Designated as safety issue: No ]
  • Change in left ventricular remodelling parameters [ Time Frame: 1 year and 3 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 600
Study Start Date: September 2008
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: April 2018 (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

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00604006

Contacts
Contact: Henry Krum, MBBS FRACP PhD +61 3 9903 0042 henry.krum@med.monash.edu.au

Locations
Australia, Victoria
Alfred Hospital Recruiting
Melbourne, Victoria, Australia, 3004
Contact: Henry Krum, MBBS FRACP PhD    +61 3 9903 0042    henry.krum@med.monash.edu.au   
Principal Investigator: Henry Krum, MBBS FRACP PhD         
Sub-Investigator: Chris Reid, A/Professor         
Sub-Investigator: Pupalan Iyngkaran, Doctor         
Sub-Investigator: Michele McGrady, Doctor         
Sponsors and Collaborators
Monash University
National Heart Foundation, Australia
Investigators
Principal Investigator: Henry Krum, MBBS FRACP PhD Monash University / Alfred Hospital
  More Information

No publications provided

Responsible Party: Prof Henry Krum, Monash University
ClinicalTrials.gov Identifier: NCT00604006     History of Changes
Other Study ID Numbers: CP-02/07
Study First Received: January 16, 2008
Last Updated: March 6, 2014
Health Authority: Australia: Human Research Ethics Committee

Keywords provided by 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
Pharmacologic Actions
Diuretics, Potassium Sparing
Diuretics
Natriuretic Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 22, 2014