Preeclampsia Vascular Studies Project 3 PVS3

• Research type

  Research Study

• Full title

  Can atorvastatin improve vascular function in women with a history preeclampsia? A Randomised, double-blinded, placebo-controlled crossover trial of atorvastatin in women with a history of preeclampsia.

• IRAS ID

  43420

• Contact name

  Brenda A Kelly

• Sponsor organisation

  University of Oxford

• Eudract number

  2008-005759-21

• ISRCTN Number

  n/a

• Research summary

  Can atorvastatin improve vascular function after preeclampsia?Women with a history of preeclampsia (high blood pressure/protein in the urine during pregnancy) are at increased risk of developing high blood pressure and heart problems in the 10-15 years after their baby is born. At present we do not know how to reduce this risk. Lowering blood pressure and blood lipid (fats) levels are common strategies for primary prevention of cardiovascular problems. However, most women with a history of preeclampsia in the 5-10 years after pregnancy, will have normal blood pressure readings, blood sugar and cholesterol levels. Atorvastatin, a type of ??statin?, is widely used in lowering lipids and preventing cardiovascular disease. This drug has beneficial actions other than lipid-lowering, that may also help prevent cardiovascular problems, including improving function in the lining of blood vessels. We know that impairment in blood vessel function is evident in women in the years after a preeclamptic pregnancy and may contribute to the risk of women after preeclampsia going on to develop cardiovascular disease. We would like to know if giving a short course of atorvastatin to women with a history of preeclampsia improves their blood vessel function. To do, this ex-preeclamptic women will be invited to take either a atorvastatin or placebo (?dummy?) tablet daily for 4 weeks, then no tablets for 4 weeks, then ??crossover? to receive the alternative tablet (placebo or atorvastatin) daily for 4 weeks. Blood vessel function would be measured using specialised non-invasive scans and taking a blood test at the beginning and end of each treatment period. The study will be jointly run by the Departments of Cardiovascular Medicine and Obstetrics & Gynaecology at the John Radcliffe Hospital, Oxford.We anticipate this study will provide valuable data to support larger clinical trials to determine whether improving blood vessel function ultimately reduces the risk of developing early-onset cardiovascular disease after preeclampsia.

• REC name

  South Central - Oxford A Research Ethics Committee

• REC reference

  10/H0604/58

• Date of REC Opinion

  29 Dec 2010

• REC opinion

  Further Information Favourable Opinion