The ALLAY trial

Phase 1

• Conditions: eft 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; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2014-002083-33-GB
• Lead Sponsor: niversity of Dundee/NHS Tayside

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-06-30
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 66

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 <135mmHg
•have screening echocardiography based diagnosis of LVH based on ASE criteria (males >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

• 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified