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

NCT00688480 | Completed Phase 4 DMC

• 1 other identifier: MK001
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Kidney Disease; Left Ventricular Hypertrophy

Keywords

CKD; LVH; Echo LVH; Chronic Stage 3

Outcome Measures

Primary Outcomes (1)

• Primary objective is to see if Allopurinol reduces left ventricular hypertrophy (LVH) in this group of CKD patients

  9 months

Secondary Outcomes (1)

• Secondary objective is to see if Allopurinol reduces endothelial dysfunction in this group of CKD patients

  9 months

Study Arms (2)

I

PLACEBO COMPARATOR

CKD Stage 3 (estimated GFR 30 - 60 ml/min/1.73m2), Echo LVH

Drug: Placebo

2

ACTIVE COMPARATOR

Drug: Allopurinol

Interventions

Placebo DRUG

1 capsule, orally for 9 months

I

Allopurinol DRUG

Allopurinol 300 mg once/day orally, 9 months

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• CKD stage 3
• Echo LVH

You may not qualify if:

• 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

Sponsors & Collaborators

• A. D. Struthers: lead

Study Sites (1)

Division of Medicine and Therapeutics, Ninewells Hospital & Medical School

Dundee, DD1 9SY, United Kingdom

Location

MeSH Terms

Conditions

Kidney Diseases; Hypertrophy, Left Ventricular; Bronchiolitis Obliterans Syndrome

Interventions

Allopurinol

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Cardiomegaly; Heart Diseases; Cardiovascular Diseases; Hypertrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease; Immune System Diseases

Intervention Hierarchy (Ancestors)

Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Allan D Struthers, BSc, MD, FRCP, FESC

  University of Dundee

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head Of Cardiovascular and Diabetes Medicine

Study Record Dates

• First Submitted: May 29, 2008
• First Posted: June 3, 2008
• Study Start: January 1, 2008
• Primary Completion: August 1, 2009
• Study Completion: February 1, 2010
• Last Updated: November 3, 2016

Record last verified: 2016-11

Locations

GB (1)