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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.


Phase 3
18 Years
N/A
Not Enrolling
Both
Heart Failure, Congestive

Thank you

Trial Information

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.


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

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.

Principal Investigator

Henry Krum, MBBS PhD FRACP

Investigator Role:

Principal Investigator

Investigator Affiliation:

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

Authority:

Australia: Department of Health and Ageing Therapeutic Goods Administration

Study ID:

4522AS/0002

NCT ID:

NCT00240292

Start Date:

February 2003

Completion Date:

Related Keywords:

  • Heart Failure, Congestive
  • Ischaemic or non-ischaemic systolic congestive heart failure
  • Heart Failure
  • Ventricular Remodeling

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