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Rosuvastatin Impact on Ventricular Remodelling Lipids and Cytokines

NCT ID: NCT00240292

Last Updated: 2010-11-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-02-28

Brief Summary

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The purpose of this study is to assess the effect of rosuvastatin (up-titrated to a dose of 40mg/day) compared to placebo on cardiac remodelling, estimated by change in left ventricular ejection fraction on radionuclide ventriculography, at 26 weeks post randomisation from baseline.

Detailed Description

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Conditions

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Heart Failure, Congestive

Keywords

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Ischaemic or non-ischaemic systolic congestive heart failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Rosuvastatin

Intervention Type DRUG

Other Intervention Names

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Crestor

Eligibility Criteria

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Inclusion Criteria

* Signed informed consent, males or females aged 18 or older, LVEF ≤ 40% assessed by RNVG or contrast ventriculogram or ≤ 35% assessed by TTE within the previous 6 months, LVEF \< 45% as assessed by RNVG during Visit 1, NYHA Class II, III or IV symptoms primarily related to heart failure, ischaemic and non-ischaemic patients and on stable heart failure therapy as defined by physician's best practice.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Principal Investigators

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Henry Krum, MBBS PhD FRACP

Role: PRINCIPAL_INVESTIGATOR

Clinical Pharmacology, Department of Epidemiology and Preventative Medicine, Monash University, Alfred Hospital

Locations

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Research Site

Canberra, Australian Capital Territory, Australia

Site Status

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Gosford, New South Wales, Australia

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Newcastle, New South Wales, Australia

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Sydney, New South Wales, Australia

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Wollongong, New South Wales, Australia

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Brisbane, Queensland, Australia

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Nambour, Queensland, Australia

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Adelaide, South Australia, Australia

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Launceston, Tasmania, Australia

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Geelong, Victoria, Australia

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Melbourne, Victoria, Australia

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Mildura, Victoria, Australia

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Research Site

Perth, Western Australia, Australia

Site Status

Countries

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Australia

Other Identifiers

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4522AS/0002

Identifier Type: -

Identifier Source: org_study_id