Allopurinol in normotensive patients with left ventricular hypertrophy

• Research type

  Research Study

• Full title

  Do Xanthine Oxidase Inhibitors reduce left ventricular hypertrophy and endothelial dysfunction in normotensive patients with chronic stable angina?

• Sponsor organisation

  University of Dundee

• Eudract number

  2008-008479-32

• ISRCTN Number

  73579730

• Research summary

  Left ventricular hypertrophy (thick heart muscle) is a risk factor for cardiovascular events. Other than high blood pressure, oxidative stress has also been found to cause left ventricular hypertrophy. Allopurinol has been found to reduce oxidative stress in previous studies.This a Medical Research Council funded study to assess whether allopurinol can reduce heart muscle thickness and improve vascular function in patients with left ventricular hypertrophy, normal blood pressure and stable angina. If it does, it will lead to a reduction in cardiovascular events in this patient group.Patients will be recruited from previous studies performed at the department or from cardiology clinics. They will be given patient information sheets about the study and questions answered by the clinical research fellow. They will have at least 24 hours to think and to discuss with family about the study. Informed consent will be obtained from the patient.Patients will be screened with an echo for left ventricular hypertrophy.66 patients will be recruited for the study - half will be randomly allocated to allopurinol (dosage will be gradually increased) and the other half will be given a placebo. Patients will continue their normal medication also. Patients will be monitored regularly for side effects, regular blood tests, urine samples, 24 hour blood pressure monitoring, cardiac MRI (to monitor heart muscle thickness) and noninvasive tests to assess vascular function.Results of the study will be analysed at the end of the study and patients will be informed of the results if requested to.It is entirely voluntary for patients to participate in this study and their refusal will have no affect on their clinical care.

• REC name

  East of Scotland Research Ethics Service REC 1

• REC reference

  09/S1401/3

• Date of REC Opinion

  19 Feb 2009

• REC opinion

  Further Information Favourable Opinion