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

Kidney Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00688480
• Other study ID #: MK001
• Status: Completed
• Phase: Phase 4
• First received: May 29, 2008
• Last updated: November 2, 2016
• Start date: January 2008
• Est. completion date: February 2010

Study information

• Verified date: November 2016
• Source: University of Dundee
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: February 2010
• Est. primary completion date: August 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertrophy
• Hypertrophy, Left Ventricular
• Kidney Disease
• Kidney Diseases
• Left Ventricular Hypertrophy
• Renal Insufficiency

Intervention

Drug:
• Placebo
1 capsule, orally for 9 months
• Allopurinol
Allopurinol 300 mg once/day orally, 9 months

Locations

Country	Name	City	State
United Kingdom	Division of Medicine and Therapeutics, Ninewells Hospital & Medical School	Dundee

Sponsors (1)

Lead Sponsor	Collaborator
A. D. Struthers

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary objective is to see if Allopurinol reduces left ventricular hypertrophy (LVH) in this group of CKD patients		9 months	No
Secondary	Secondary objective is to see if Allopurinol reduces endothelial dysfunction in this group of CKD patients		9 months	No