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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00240292




Registration number
NCT00240292
Ethics application status
Date submitted
16/10/2005
Date registered
18/10/2005
Date last updated
19/11/2010

Titles & IDs
Public title
Rosuvastatin Impact on Ventricular Remodelling Lipids and Cytokines
Scientific 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.
Secondary ID [1] 0 0
4522AS/0002
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Heart Failure, Congestive 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Rosuvastatin

Treatment: Drugs: Rosuvastatin
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
Secondary outcome [1] 0 0
Determine the effects of rosuvastatin (up-titrated to a dose of 40mg/day) compared to placebo by measuring:
Timepoint [1] 0 0
Secondary outcome [2] 0 0
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.
Timepoint [2] 0 0
Secondary outcome [3] 0 0
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
Timepoint [3] 0 0
Secondary outcome [4] 0 0
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 a and interleukin 6.
Timepoint [4] 0 0
Secondary outcome [5] 0 0
Assess the safety of rosuvastatin over 26 weeks determined by the incidence and severity of adverse events and abnormal laboratory values.
Timepoint [5] 0 0
Secondary outcome [6] 0 0
Assess change in quality of life score, as determined by the Minnesota Living with Heart Failure questionnaire.
Timepoint [6] 0 0

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/02/2003
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,TAS,VIC,WA
Recruitment hospital [1] 0 0
Research Site - Canberra
Recruitment hospital [2] 0 0
Research Site - Gosford
Recruitment hospital [3] 0 0
Research Site - Newcastle
Recruitment hospital [4] 0 0
Research Site - Sydney
Recruitment hospital [5] 0 0
Research Site - Wollongong
Recruitment hospital [6] 0 0
Research Site - Brisbane
Recruitment hospital [7] 0 0
Research Site - Nambour
Recruitment hospital [8] 0 0
Research Site - Adelaide
Recruitment hospital [9] 0 0
Research Site - Launceston
Recruitment hospital [10] 0 0
Research Site - Geelong
Recruitment hospital [11] 0 0
Research Site - Melbourne
Recruitment hospital [12] 0 0
Research Site - Mildura
Recruitment hospital [13] 0 0
Research Site - Perth
Recruitment postcode(s) [1] 0 0
- Canberra
Recruitment postcode(s) [2] 0 0
- Gosford
Recruitment postcode(s) [3] 0 0
- Newcastle
Recruitment postcode(s) [4] 0 0
- Sydney
Recruitment postcode(s) [5] 0 0
- Wollongong
Recruitment postcode(s) [6] 0 0
- Brisbane
Recruitment postcode(s) [7] 0 0
- Nambour
Recruitment postcode(s) [8] 0 0
- Adelaide
Recruitment postcode(s) [9] 0 0
- Launceston
Recruitment postcode(s) [10] 0 0
- Geelong
Recruitment postcode(s) [11] 0 0
- Melbourne
Recruitment postcode(s) [12] 0 0
- Mildura
Recruitment postcode(s) [13] 0 0
- Perth

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
AstraZeneca
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00240292
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Henry Krum, MBBS PhD FRACP
Address 0 0
Clinical Pharmacology, Department of Epidemiology and Preventative Medicine, Monash University, Alfred Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries