Rosuvastatin Impact on Ventricular Remodelling Lipids and Cytokines

Heart Failure, Congestive Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00240292
• Other study ID #: 4522AS/0002
• Status: Completed
• Phase: Phase 3
• First received: October 16, 2005
• Last updated: November 18, 2010
• Start date: February 2003

Study information

• Verified date: November 2010
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure, Congestive
• Ventricular Remodeling

Intervention

Drug:
• Rosuvastatin

Locations

Country	Name	City	State
Australia	Research Site	Adelaide	South Australia
Australia	Research Site	Brisbane	Queensland
Australia	Research Site	Canberra	Australian Capital Territory
Australia	Research Site	Geelong	Victoria
Australia	Research Site	Gosford	New South Wales
Australia	Research Site	Launceston	Tasmania
Australia	Research Site	Melbourne	Victoria
Australia	Research Site	Mildura	Victoria
Australia	Research Site	Nambour	Queensland
Australia	Research Site	Newcastle	New South Wales
Australia	Research Site	Perth	Western Australia
Australia	Research Site	Sydney	New South Wales
Australia	Research Site	Wollongong	New South Wales

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Determine the effects of rosuvastatin (up-titrated to a dose of 40mg/day) compared to placebo by measuring:
Secondary	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.
Secondary	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
Secondary	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.
Secondary	Assess the safety of rosuvastatin over 26 weeks determined by the incidence and severity of adverse events and abnormal laboratory values.
Secondary	Assess change in quality of life score, as determined by the Minnesota Living with Heart Failure questionnaire.