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

Tracking Information

First Received Date ^ICMJE

January 16, 2008

Last Updated Date

August 18, 2009

Start Date ^ICMJE

September 2008

Estimated Primary Completion Date

April 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Effectiveness of Spironolactone in preventing heart failure [ Time Frame: 1 year and 2 year ] [ Designated as safety issue: No ]
Cost effectiveness of Spironolactone prevention [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00604006 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Development of evidence of LV dysfunction, either systolic or diastolic, on echocardiography and/or symptomatic heart failure [ Time Frame: 1 year and 2 year ] [ Designated as safety issue: No ]
Change in 6 minute walk test between the two groups [ Time Frame: 1 year and 2 years ] [ Designated as safety issue: No ]
Change in quality of life between the two groups [ Time Frame: 1 year and 2 year ] [ Designated as safety issue: No ]
Change in left ventricular remodelling parameters [ Time Frame: 1 year and 2 years ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

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 apart 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 two 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

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Prevention, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study

Condition ^ICMJE

Heart Failure

Intervention ^ICMJE

Drug: Spironolactone
Drug: Placebo

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

600

Estimated Completion Date

April 2010

Estimated Primary Completion Date

April 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Was recruited to SCREEN-HF
Has provided informed consent

Exclusion Criteria:

Uncorrected hyperkalaemia
eGFR < 30 ml/min

Gender

Both

Ages

60 Years and older

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact: Henry Krum, MBBS FRACP PhD

+61 3 9903 0042

henry.krum@med.monash.edu.au

Location Countries ^ICMJE

Australia

Administrative Information

NCT ID ^ICMJE

NCT00604006

Responsible Party

Prof Henry Krum, Monash University / Alfred Hospital

Study ID Numbers ^ICMJE

CP-02/07

Study Sponsor ^ICMJE

Monash University

Collaborators ^ICMJE

National Heart Foundation

Investigators ^ICMJE

Principal Investigator:

Henry Krum, MBBS FRACP PhD

Monash University / Alfred Hospital

Information Provided By

Monash University

Verification Date

August 2009

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