Status:
COMPLETED
Does Allopurinol Reduce Thickening of the Left Ventricle of the Heart in Patient With Treated Hypertension?
Lead Sponsor:
University of Dundee
Collaborating Sponsors:
British Heart Foundation
Conditions:
Hypertension
Hypertrophy, Left Ventricular
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 increas...
Detailed Description
Does Allopurinol regress Left Ventricular Hypertrophy in Patients with Treated Essential Hypertension? People with high blood pressure are at increased risk of heart complications. One of the biggest...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2017
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT02237339
Start Date
September 1 2014
End Date
June 1 2017
Last Update
September 17 2019
Active Locations (1)
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1
University of Dundee, Ninewells Hospital
Dundee, Tayside, United Kingdom, DD1 9SY