Rosuvastatin Impact on Ventricular Remodelling Lipids and Cytokines
Information source: AstraZeneca
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Heart Failure, Congestive
Intervention: Rosuvastatin (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: AstraZeneca Official(s) and/or principal investigator(s):
Henry Krum, MBBS PhD FRACP, Principal Investigator, Affiliation: Clinical Pharmacology, Department of Epidemiology and Preventative Medicine, Monash University, Alfred Hospital
Summary
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.
Clinical Details
Official title: A Double-Blind, Randomised, Placebo-Controlled, Parallel-Group, Multicentre, Phase III Study to Assess the Impact of Rosuvastatin Treatment for 26 Weeks (Titrated to a Maximum Dose of 40mg Once Daily) on Left Ventricular Function, Cytokines and Lipid Parameters in Patients With Established Systolic Chronic Heart Failure.
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Primary outcome: Determine 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 randomization from baseline.
Secondary outcome: Determine the effects of rosuvastatin (up-titrated to a dose of 40mg/day) compared to placebo by measuring: Changes from baseline at 26 weeks post-randomisation, of left ventricular (LV) end-diastolic and end-systolic diameter, and LV fraction shortening, as determined by transthoracic echocardiography. The percentage change in lipid parameters: total cholesterol, low density lipoprotein cholesterol, high-density lipoprotein cholesterol and triglycerides after 6, 12 and 26 weeks post-randomisation Changes from baseline at 26 weeks post-randomisation in neurohormonal and immunological markers: norepinephrine, endothelin, N-terminal pro-brain natriuretic peptide, high-sensitivity C-reactive protein, tumour necrosis factor α and interleukin 6. Assess the safety of rosuvastatin over 26 weeks determined by the incidence and severity of adverse events and abnormal laboratory values. Assess change in quality of life score, as determined by the Minnesota Living with Heart Failure questionnaire.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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.
Exclusion Criteria:
- Key exclusion criteria include acute myocarditis within the last 12 months, diabetes
mellitus not controlled by diet, oral therapy or insulin therapy, homozygous familial
hypercholesterolaemia, receiving biventricular pacing or expected to receive
biventricular pacing in the next 6 months, subjects who normally would be considered
for statin therapy in the next 6 months, sever hypertension, history of definite
myocardial infarction, cerebrovascular accident, percutaneous transluminal coronary
angioplasty or coronary bypass graft within 3 months prior to enrolment in the study,
body mass index < 15, plus others.
Locations and Contacts
Research Site, Canberra, Australian Capital Territory, Australia
Research Site, Sydney, New South Wales, Australia
Research Site, Wollongong, New South Wales, Australia
Research Site, Newcastle, New South Wales, Australia
Research Site, Gosford, New South Wales, Australia
Research Site, Brisbane, Queensland, Australia
Research Site, Nambour, Queensland, Australia
Research Site, Adelaide, South Australia, Australia
Research Site, Launceston, Tasmania, Australia
Research Site, Melbourne, Victoria, Australia
Research Site, Geelong, Victoria, Australia
Research Site, Mildura, Victoria, Australia
Research Site, Perth, Western Australia, Australia
Additional Information
Starting date: February 2003
Last updated: October 16, 2005
|
