Left ventricular hypertrophy in hypertension MedDRA version: 17.0 Level: PT Classification code 10049773 Term: Left ventricular hypertrophy System Organ Class: 10007541 - Cardiac disorders MedDRA version: 17.0 Level: PT Classification code 10015488 Term: Essential hypertension System Organ Class: 10047065 - Vascular disorders
Conditions
Sponsors
University of Dundee/NHS Tayside
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • are aged over 18 years • previously diagnosed with essential hypertension • been on stable antihypertensive therapy for at least 3 months prior to study screening •have screening ABPM (or home based BP monitoring if ABPM not tolerated) with daytime average systolic 115g/m2, females >95g/m2) Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 22 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 44
Exclusion criteria
Exclusion criteria: • documented intolerance to allopurinol • left Ventricular Ejection Fraction <45% on echocardiography screening • severe aortic stenosis on echocardiography screening • already had gout or currently on allopurinol • severe hepatic disease • renal disease; CKD class 3B or worse • on azathioprine, 6 mercaptopurine, or theophylline • malignancy (receiving active treatment) or other life threatening diseases • pregnant or lactating women • any contraindication to MRI (claustrophobia, metal implants) • patients who have participated in any other clinical trial of an investigational medicinal product within the previous 30 days will be excluded. • patients who are unable to give informed consent • any other considered by a study physician to be inappropriate for inclusion
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary research objective is to test if allopurinol can reduce thickening of the heart muscle in patients with treated high blood pressure. ; Secondary Objective: The secondary research objectives are to find out if allopurinol improves stiffness of arteries in patients with treated high blood pressure. We also aim to find out if adding allopurinol to the participants current high blood pressure treatment improves blood pressure control. Additionally the participants blood tests will be checked to see if there are any changes in markers of inflammation whilst on allopurinol. The MRI scans will be compared against ECG measurements (ECGs can be tolerated by all patients whilst MRIs may not, so if the MRI scan findings are duplicated on the ECG it will help with future assessments of the effect of allopurinol in patients with treated high BP). Finally the MRI scans will also be checked to see if there are any other improvements in the health of the heart, in addition to the primary objective of seeing if it may improve the effect of thickening of the heart. ;Primary end point(s): The primary outcome is to determine if allopurinol induces a change in Left Ventricular Mass Index in patients with treated hypertension when compared to placebo.;Timepoint(s) of evaluation of this end point: 1 year for primary endpoint | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1: change in LV Mass, LV end systolic volume, LV end diastolic volume or LV ejection factor 2; difference in endothelial function measured by Flow mediated dilatation and Pulse Wave Analysis. 3: changes in inflammatory and other blood markers 4: changes in BP control as measured by 24hr BP monitoring ; Timepoint(s) of evaluation of this end point: 1; 1 year 2; 9 month and 1 year 3; 1 year 4; 1 year | — |
Countries
United Kingdom
Contacts
Public ContactMcSwiggan
University of Dundee, Tayside Clinical Trials Unit
Outcome results
None listed