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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.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00688480
First Posted: June 3, 2008
Last Update Posted: November 3, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
A. D. Struthers, University of Dundee
  Purpose
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
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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 A. D. Struthers, 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 ]

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

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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00688480


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

Responsible Party: A. D. Struthers, Head Of Cardiovascular and Diabetes Medicine, University of Dundee
ClinicalTrials.gov Identifier: NCT00688480     History of Changes
Other Study ID Numbers: MK001
First Submitted: May 29, 2008
First Posted: June 3, 2008
Last Update Posted: November 3, 2016
Last Verified: November 2016

Keywords provided by A. D. Struthers, University of Dundee:
CKD
LVH
Echo LVH
Chronic Stage 3

Additional relevant MeSH terms:
Kidney Diseases
Hypertrophy
Hypertrophy, Left Ventricular
Renal Insufficiency
Urologic Diseases
Pathological Conditions, Anatomical
Cardiomegaly
Heart Diseases
Cardiovascular Diseases
Allopurinol
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Gout Suppressants
Antirheumatic Agents
Free Radical Scavengers
Antioxidants
Protective Agents
Physiological Effects of Drugs