RCT of statin in SLE

• Research type

  Research Study

• Full title

  A randomised placebo controlled trial of rosuvastatin in systemic lupus erythematosus.

• Sponsor organisation

  Imperial College; point of contact Mr Gary Roper

• Eudract number

  2006-006214-16

• ISRCTN Number

  N/A

• Research summary

  Systemic Lupus Erythematosus (SLE) is a condition which 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 2 years. We also want to see how it affects the function of the blood vessels and also of the heart.Individuals from Northwick Park Hospital and Imperial College Hospitals NHS Trust, 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 at the Royal Brompton Hospital before the start of 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 provide evidence that rosuvastatin can 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.

• REC name

  London - South East Research Ethics Committee

• REC reference

  08/H1102/110

• Date of REC Opinion

  15 Dec 2008

• REC opinion

  Further Information Favourable Opinion