Does Allopurinol Reduce Thickening of the Left Ventricle of the Heart in Patient With Treated Hypertension?

• Status: Completed
• Trial end date: 2017-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The presence of Left ventricular hypertrophy (LVH) confers high cardiovascular risk in hypertensive patients. LVH remains highly prevalent even when blood pressure (BP) is controlled. There is increasing evidence that a major non-haemodynamic contributor to LVH is oxidative stress. Allopurinol is known to markedly reduce oxidative stress.

This pragmatic randomised double blind placebo controlled trial will examine whether allopurinol (300 mg bd) regresses LV mass as assessed by cardiac magnetic resonance (CMR) in 66 patients with treated hypertension but who have persisting LVH.

Endothelial and vascular function will also be assessed via flow mediated dilatation (FMD) and pulse wave analysis respectively (PWA) and plasma biomarkers of oxidative stress will be measured. The treatment (allopurinol or placebo) will last 12 months.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Dundee
• Collaborator: British Heart Foundation
• Treatments: Allopurinol

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 ambulatory bloods pressure monitoring (ABPM) or home based BP monitoring if ABPM not tolerated with daytime average systolic <135mmHg

• have screening echocardiography based diagnosis of left ventricular hypertrophy (LVH) based on American society of echocardiography (ASE) criteria (males >115g/m2, females >95g/m2)

Exclusion Criteria:

• documented intolerance to allopurinol

• left Ventricular Ejection Fraction <45% on echocardiography screening

• severe aortic stenosis on echocardiography screening

• active gout (i.e. flare within two years) or currently on allopurinol

• severe hepatic disease

• renal disease; chronic kidney 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 magnetic resonance imaging (MRI) (claustrophobia, metal implants, penetrative eye injury or exposure to metal fragments in eye requiring medical attention).

• 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.