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

Sponsors and Collaborators:	Monash University National Heart Foundation
Information provided by:	Monash University
ClinicalTrials.gov Identifier:	NCT00604006

Purpose

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.

Condition	Intervention	Phase
Heart Failure	Drug: Spironolactone Drug: Placebo	Phase III

MedlinePlus related topics: Heart Failure

Drug Information available for: Lactose Spironolactone

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	SCREEN-HFI (SCReening Evaluation of the Evolution of New Heart Failure Intervention Study)

Further study details as provided by Monash University:

Primary Outcome Measures:

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 ]

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 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 ]

Estimated Enrollment:	600
Study Start Date:	September 2008
Estimated Study Completion Date:	April 2010
Estimated Primary Completion Date:	April 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Group A: Experimental	Drug: Spironolactone 25 mg tablets (placed in capsules for blinding) once daily.
Group B: Placebo Comparator	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:

Was recruited to SCREEN-HF
Has provided informed consent

Exclusion Criteria:

Uncorrected hyperkalaemia
eGFR < 30 ml/min

Contacts and Locations

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
Melbourne, Victoria, Australia, 3004

Sponsors and Collaborators

Monash University

National Heart Foundation

Investigators

Principal Investigator:

Henry Krum, MBBS FRACP PhD

Monash University / Alfred Hospital

More Information

Responsible Party:	Monash University / Alfred Hospital ( Prof Henry Krum )
Study ID Numbers:	CP-02/07
Study First Received:	January 16, 2008
Last Updated:	August 7, 2008
ClinicalTrials.gov Identifier:	NCT00604006
Health Authority:	Australia: Human Research Ethics Committee

Keywords provided by Monash University:

Prevention of heart failure in individuals at high risk

Study placed in the following topic categories:

Heart Failure
Heart Diseases
Spironolactone

Additional relevant MeSH terms:

Aldosterone Antagonists
Natriuretic Agents
Therapeutic Uses
Hormone Antagonists
Physiological Effects of Drugs

Diuretics
Hormones, Hormone Substitutes, and Hormone Antagonists
Cardiovascular Diseases
Cardiovascular Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009