Back to resultsRosuvastatin Impact on Ventricular Remodelling Lipids and Cytokines
Primary Purpose
Heart Failure, Congestive
Status
Completed
Phase
Phase 3
Locations
Australia
Study Type
Interventional
Intervention
Rosuvastatin
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure, Congestive focused on measuring Ischaemic or non-ischaemic systolic congestive heart failure
Eligibility 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.
Sites / Locations
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Outcomes
Primary Outcome Measures
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 Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00240292
Brief Title
Rosuvastatin Impact on Ventricular Remodelling Lipids and Cytokines
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 Type
Interventional
2. Study Status
Record Verification Date
November 2010
Overall Recruitment Status
Completed
Study Start Date
February 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
AstraZeneca
4. Oversight
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Congestive
Keywords
Ischaemic or non-ischaemic systolic congestive heart failure
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
160 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Rosuvastatin
Other Intervention Name(s)
Crestor
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Determine the effects of rosuvastatin (up-titrated to a dose of 40mg/day) compared to placebo by measuring:
Title
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.
Title
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
Title
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.
Title
Assess the safety of rosuvastatin over 26 weeks determined by the incidence and severity of adverse events and abnormal laboratory values.
Title
Assess change in quality of life score, as determined by the Minnesota Living with Heart Failure questionnaire.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Henry Krum, MBBS PhD FRACP
Organizational Affiliation
Clinical Pharmacology, Department of Epidemiology and Preventative Medicine, Monash University, Alfred Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Research Site
City
Canberra
State/Province
Australian Capital Territory
Country
Australia
Facility Name
Research Site
City
Gosford
State/Province
New South Wales
Country
Australia
Facility Name
Research Site
City
Newcastle
State/Province
New South Wales
Country
Australia
Facility Name
Research Site
City
Sydney
State/Province
New South Wales
Country
Australia
Facility Name
Research Site
City
Wollongong
State/Province
New South Wales
Country
Australia
Facility Name
Research Site
City
Brisbane
State/Province
Queensland
Country
Australia
Facility Name
Research Site
City
Nambour
State/Province
Queensland
Country
Australia
Facility Name
Research Site
City
Adelaide
State/Province
South Australia
Country
Australia
Facility Name
Research Site
City
Launceston
State/Province
Tasmania
Country
Australia
Facility Name
Research Site
City
Geelong
State/Province
Victoria
Country
Australia
Facility Name
Research Site
City
Melbourne
State/Province
Victoria
Country
Australia
Facility Name
Research Site
City
Mildura
State/Province
Victoria
Country
Australia
Facility Name
Research Site
City
Perth
State/Province
Western Australia
Country
Australia
12. IPD Sharing Statement
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Rosuvastatin Impact on Ventricular Remodelling Lipids and Cytokines
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