Do Xanthine Oxidase Inhibitors Reduce Both Left Ventricular Hypertrophy and Endothelial Dysfunction in Cardiovascular Patients With Renal Dysfunction?

Phase 4

Completed

• Conditions: Left Ventricular Hypertrophy; Kidney Disease
• Interventions: Drug: Placebo; Drug: Allopurinol

• Registration Number: NCT00688480
• Lead Sponsor: A. D. Struthers

Brief Summary

Cardiovascular related disease is the main cause of death in patients with kidney disease, and "oxidative stress" is thought to be a major contributor by promoting thickening of the heart muscle and stiffening of the arteries. Allopurinol, a drug used safely in the treatment of gout for many years, has been found to dramatically reduce "oxidative stress". It is therefore hoped that it also reduce the thickened heart muscle and stiffened arteries. If it did, it is likely to reduce the appallingly high cardiac death rate in this group of kidney disease patients.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-01
• Study First Submitted: 2008-05-29
• Study First Submitted QC: 2008-06-02
• Study First Posted: 2008-06-03
• Primary Completion: 2009-08
• Study Completion: 2010-02
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-02
• Last Update Posted: 2016-11-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 67

Inclusion Criteria

• CKD stage 3
• Echo LVH

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Exclusion Criteria

• Known heart failure
• Patients already on Allopurinol
• Patients with gout
• Patients with hepatic disease
• Contraindications to MRI, including severe claustrophobia
• Current immunosuppressive therapy, chlorpropamide, theophylline, 6- mercaptopurine
• Malignancy or other life threatening disease
• Pregnancy or lactating women
• Patients unable to provide written consent

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
I	Placebo	CKD Stage 3 (estimated GFR 30 - 60 ml/min/1.73m2), Echo LVH
2	Allopurinol	-

Primary Outcome Measures

Name	Time	Method
Primary objective is to see if Allopurinol reduces left ventricular hypertrophy (LVH) in this group of CKD patients	9 months

Secondary Outcome Measures

Name	Time	Method
Secondary objective is to see if Allopurinol reduces endothelial dysfunction in this group of CKD patients	9 months

Trial Locations

Locations (1)

Division of Medicine and Therapeutics, Ninewells Hospital & Medical School; 🇬🇧 Dundee, United Kingdom