Rosuvastatin Impact on Ventricular Remodelling Lipids and Cytokines
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00240292|
Recruitment Status : Completed
First Posted : October 18, 2005
Last Update Posted : November 19, 2010
|Condition or disease||Intervention/treatment||Phase|
|Heart Failure, Congestive||Drug: Rosuvastatin||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||160 participants|
|Intervention Model:||Parallel Assignment|
|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 Start Date :||February 2003|
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00240292
|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|