Rosuvastatin Impact on Ventricular Remodelling Lipids and Cytokines
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|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.|
- 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.
- 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.
|Study Start Date:||February 2003|
|Australia, Australian Capital Territory|
|Canberra, Australian Capital Territory, Australia|
|Australia, New South Wales|
|Gosford, New South Wales, Australia|
|Newcastle, New South Wales, Australia|
|Sydney, New South Wales, Australia|
|Wollongong, New South Wales, Australia|
|Brisbane, Queensland, Australia|
|Nambour, Queensland, Australia|
|Australia, South Australia|
|Adelaide, South Australia, Australia|
|Launceston, Tasmania, Australia|
|Geelong, Victoria, Australia|
|Melbourne, Victoria, Australia|
|Mildura, Victoria, Australia|
|Australia, Western Australia|
|Perth, Western Australia, Australia|
|Principal Investigator:||Henry Krum, MBBS PhD FRACP||Clinical Pharmacology, Department of Epidemiology and Preventative Medicine, Monash University, Alfred Hospital|