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

This study has been completed.
Information provided by:
University of Dundee Identifier:
First received: May 29, 2008
Last updated: June 24, 2010
Last verified: May 2008
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.

Condition Intervention Phase
Kidney Disease
Left Ventricular Hypertrophy
Drug: Placebo
Drug: Allopurinol
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Do Xanthine Oxidase Inhibitors Reduce Both Left Ventricular Hypertrophy and Endothelial Dysfunction in Cardiovascular Patients With Renal Dysfunction?

Resource links provided by NLM:

Further study details as provided by University of Dundee:

Primary Outcome Measures:
  • Primary objective is to see if Allopurinol reduces left ventricular hypertrophy (LVH) in this group of CKD patients [ Time Frame: 9 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Secondary objective is to see if Allopurinol reduces endothelial dysfunction in this group of CKD patients [ Time Frame: 9 months ] [ Designated as safety issue: No ]

Enrollment: 67
Study Start Date: January 2008
Study Completion Date: February 2010
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: I
CKD Stage 3 (estimated GFR 30 - 60 ml/min/1.73m2), Echo LVH
Drug: Placebo
1 capsule, orally for 9 months
Active Comparator: 2 Drug: Allopurinol
Allopurinol 300 mg once/day orally, 9 months


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • CKD stage 3
  • Echo LVH

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00688480

United Kingdom
Division of Medicine and Therapeutics, Ninewells Hospital & Medical School
Dundee, United Kingdom, DD1 9SY
Sponsors and Collaborators
University of Dundee
Principal Investigator: Allan D Struthers, BSc, MD, FRCP, FESC University of Dundee
  More Information

Responsible Party: Professor Allan Struthers, University of Dundee Identifier: NCT00688480     History of Changes
Other Study ID Numbers: MK001 
Study First Received: May 29, 2008
Last Updated: June 24, 2010
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by University of Dundee:
Echo LVH
Chronic Stage 3

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency
Hypertrophy, Left Ventricular
Urologic Diseases
Pathological Conditions, Anatomical
Heart Diseases
Cardiovascular Diseases
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Gout Suppressants
Antirheumatic Agents
Free Radical Scavengers
Protective Agents
Physiological Effects of Drugs processed this record on October 21, 2016