Rosuvastatin Impact on Ventricular Remodelling Lipids and Cytokines - Full Text View

Sponsor:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00240292

Purpose

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.

Condition	Intervention	Phase
Heart Failure, Congestive	Drug: Rosuvastatin	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
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.

Resource links provided by NLM:

MedlinePlus related topics: Heart Failure

Drug Information available for: Lipids Rosuvastatin calcium Rosuvastatin

U.S. FDA Resources

Further study details as provided by AstraZeneca:

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.

Estimated Enrollment:	160
Study Start Date:	February 2003

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00240292

Locations

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

Sponsors and Collaborators

AstraZeneca

Investigators

Principal Investigator:

Henry Krum, MBBS PhD FRACP

Clinical Pharmacology, Department of Epidemiology and Preventative Medicine, Monash University, Alfred Hospital

More Information

No publications provided

Study ID Numbers:	4522AS/0002
Study First Received:	October 16, 2005
Last Updated:	October 16, 2005
ClinicalTrials.gov Identifier:	NCT00240292 History of Changes
Health Authority:	Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by AstraZeneca:

Ischaemic or non-ischaemic systolic congestive heart failure

Additional relevant MeSH terms:

Antimetabolites
Heart Failure
Rosuvastatin
Heart Diseases
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses

Antilipemic Agents
Enzyme Inhibitors
Cardiovascular Diseases
Anticholesteremic Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 08, 2010