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

November 2, 2016 updated by: A. D. Struthers
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

67

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Dundee, United Kingdom, DD1 9SY
        • Division of Medicine and Therapeutics, Ninewells Hospital & Medical School

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: 2
Drug: Allopurinol
Allopurinol 300 mg once/day orally, 9 months
PLACEBO_COMPARATOR: I
CKD Stage 3 (estimated GFR 30 - 60 ml/min/1.73m2), Echo LVH
Drug: Placebo
1 capsule, orally for 9 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Primary objective is to see if Allopurinol reduces left ventricular hypertrophy (LVH) in this group of CKD patients
Time Frame: 9 months
9 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Secondary objective is to see if Allopurinol reduces endothelial dysfunction in this group of CKD patients
Time Frame: 9 months
9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

A. D. Struthers

Investigators

  • Principal Investigator: Allan D Struthers, BSc, MD, FRCP, FESC, University of Dundee

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (ACTUAL)

August 1, 2009

Study Completion (ACTUAL)

February 1, 2010

Study Registration Dates

First Submitted

May 29, 2008

First Submitted That Met QC Criteria

June 2, 2008

First Posted (ESTIMATE)

June 3, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

November 3, 2016

Last Update Submitted That Met QC Criteria

November 2, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MK001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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