A Trial of Rosuvastatin in Systemic Lupus Erythematosus

• Status: Completed
• Trial end date: 2014-06-01
• Target enrollment: 0
• Participant gender: All

Summary

Systemic Lupus Erythematosus (SLE) is a condition that affects the whole body. It can cause inflammation of the blood vessels resulting in an earlier thickening and hardening of the arteries resulting in strokes. It has been reported that SLE can worsen the function resulting in heart failure.

The aim of the study is to examine what effects Rosuvastatin, a cholesterol lowering drug, given to patients has on the degree of thickening of the arteries over the course of two years. We also want to see how it affects the function of the blood vessels and also of the heart.

Individuals who agree to participate will be randomly assigned into two groups. One group will be given the active drug whereas the other will have a placebo. Subjects in the study will all have a cardiac magnetic resonance (CMR) scan before treatment, at 1 year and then 2 years at the end of the treatment. Each scan will involve imaging the carotid arteries in the neck, the arteries in the arm and also the heart. Individuals will continue to have regular out-patient reviews by their own team of doctors, regular blood tests will be taken to monitor the disease and also to ensure the safety and well being of the individual.

At the end of the 2 year study we hope that we will be able to slow down the rate of arterial thickening and retard any plaque build up in the arteries. We also want to see what effect rosuvastatin has on heart function. Ultimately, we hope to prove that people with SLE should be treated with a cholesterol lowering drug as part of their routine treatment.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Imperial College London
• Treatments: Rosuvastatin Calcium

Criteria

Inclusion Criteria:

• Subjects with SLE-as diagnosed by ACR criteria

• Male or females who are 18-80years of age, inclusive at screening

• Female subjects who are post menopausal (i.e >6mnths without menstrual period), surgically sterile, or using effective contraceptive measures at visit 0 and the same contraception throughout the study and for 30days after discontinuing treatment

• No current or previous statin therapy

• No current indication for statin therapy (Coronary artery disease; hypercholesterolemia, renal dysfunction)

• Subjects who have given their signed consent to participate in the study

Exclusion Criteria:

• Patient < 18 or > 80 years

• Contraindications for MRI - patients with pacemakers' defibrillators or pacing wires in the heart, or other metal implants such as metal in the eye, brain or spine. Other metallic devices or implants will have to be declared by the participant and assessed to be safe prior to having an MRI current or previous statin

• Known atherosclerotic valvular disease

• Renal dysfunction

• Hyperlipidemia

• Active myositis

• All forms of liver disease

• Pregnancy

• Breastfeeding

• Patients being treated with Cyclosporin A