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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rosuvastatin | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Henry Krum, MBBS PhD FRACP | Clinical Pharmacology, Department of Epidemiology and Preventative Medicine, Monash University, Alfred Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Canberra | Australian Capital Territory | Australia | |||
| Research Site |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D007511 | Ischemia |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000068718 | Rosuvastatin Calcium |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D005464 | Fluorobenzenes |
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| 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. |
| Gosford |
| New South Wales |
| Australia |
| Research Site | Newcastle | New South Wales | Australia |
| Research Site | Sydney | New South Wales | Australia |
| Research Site | Wollongong | 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 | Geelong | Victoria | Australia |
| Research Site | Melbourne | Victoria | Australia |
| Research Site | Mildura | Victoria | Australia |
| Research Site | Perth | Western Australia | Australia |
| D006845 |
| Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |