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

This study is currently recruiting participants.

Verified by University of Dundee, May 2008

First Received: May 29, 2008 Last Updated: July 10, 2008 History of Changes

Sponsor:	University of Dundee
Information provided by:	University of Dundee
ClinicalTrials.gov Identifier:	NCT00688480

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 IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
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:

Drug Information available for: Allopurinol sodium Allopurinol

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 ]

Estimated Enrollment:	60
Study Start Date:	January 2008
Estimated Study Completion Date:	November 2009
Estimated Primary Completion Date:	November 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
I: Placebo Comparator CKD Stage 3 (estimated GFR 30 - 60 ml/min/1.73m2), Echo LVH	Drug: Placebo 1 capsule, orally for 9 months
2: Active Comparator	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

Contacts

Contact: Michelle Kao, MBChB, MRCP	44-138-266-0111 ext 33452	m.kao@dundee.ac.uk
Contact: Allan Struthers, MBChB, MRCP, MD, FRCP	44-138-263-2180	a.d.struthers@dundee.ac.uk

Locations

United Kingdom
Division of Medicine and Therapeutics, Ninewells Hospital & Medical School	Recruiting
Dundee, United Kingdom, DD1 9SY
Contact: Michelle Kao 44-138-266-0111 ext 33452 m.kao@dundee.ac.uk

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:	University of Dundee ( Professor Allan Struthers )
Study ID Numbers:	MK001
Study First Received:	May 29, 2008
Last Updated:	July 10, 2008
ClinicalTrials.gov Identifier:	NCT00688480 History of Changes
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:

Pathological Conditions, Anatomical
Antimetabolites
Hypertrophy, Left Ventricular
Allopurinol
Antioxidants
Heart Diseases
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Enzyme Inhibitors
Protective Agents

Gout Suppressants
Pharmacologic Actions
Hypertrophy
Urologic Diseases
Therapeutic Uses
Free Radical Scavengers
Cardiovascular Diseases
Kidney Diseases
Antirheumatic Agents
Cardiomegaly

ClinicalTrials.gov processed this record on November 25, 2009