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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:
Information provided by:
University of Dundee
ClinicalTrials.gov Identifier:
NCT00688480
First received: May 29, 2008
Last updated: June 24, 2010
Last verified: May 2008
History of Changes
  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
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:

U.S. FDA Resources

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00688480

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

No publications provided

Responsible Party: Professor Allan Struthers, University of Dundee
ClinicalTrials.gov 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:
CKD
LVH
Echo LVH
Chronic Stage 3

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

ClinicalTrials.gov processed this record on May 19, 2013