NCT00240292

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 Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P25-P50 for phase_3

Geographic Reach
1 country

13 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2003

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

October 16, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 18, 2005

Completed
Last Updated

November 19, 2010

Status Verified

November 1, 2010

First QC Date

October 16, 2005

Last Update Submit

November 18, 2010

Conditions

Heart Failure, Congestive

Keywords

Ischaemic or non-ischaemic systolic congestive heart failure

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • 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.

  • +1 more secondary outcomes

Interventions

RosuvastatinDRUG
Also known as: Crestor

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

Research Site

Canberra, Australian Capital Territory, Australia

Location

Research Site

Gosford, New South Wales, Australia

Location

Research Site

Newcastle, New South Wales, Australia

Location

Research Site

Sydney, New South Wales, Australia

Location

Research Site

Wollongong, New South Wales, Australia

Location

Research Site

Brisbane, Queensland, Australia

Location

Research Site

Nambour, Queensland, Australia

Location

Research Site

Adelaide, South Australia, Australia

Location

Research Site

Launceston, Tasmania, Australia

Location

Research Site

Geelong, Victoria, Australia

Location

Research Site

Melbourne, Victoria, Australia

Location

Research Site

Mildura, Victoria, Australia

Location

Research Site

Perth, Western Australia, Australia

Location

MeSH Terms

Conditions

Heart FailureIschemia

Interventions

Rosuvastatin Calcium

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

SulfonamidesAmidesOrganic ChemicalsFluorobenzenesHydrocarbons, FluorinatedHydrocarbons, HalogenatedHydrocarbonsSulfonesSulfur CompoundsPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Henry Krum, MBBS PhD FRACP

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 16, 2005

First Posted

October 18, 2005

Study Start

February 1, 2003

Last Updated

November 19, 2010

Record last verified: 2010-11

Locations

AU(13)