Back to resultsDo Xanthine Oxidase Inhibitors Reduce Both Left Ventricular Hypertrophy and Endothelial Dysfunction in Cardiovascular Patients With Renal Dysfunction?
Primary Purpose
Kidney Disease, Left Ventricular Hypertrophy
Status
Completed
Phase
Phase 4
Locations
United Kingdom
Study Type
Interventional
Intervention
Placebo
Allopurinol
Sponsored by
About this trial
This is an interventional treatment trial for Kidney Disease focused on measuring CKD, LVH, Echo LVH, Chronic Stage 3
Eligibility 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
Sites / Locations
- Division of Medicine and Therapeutics, Ninewells Hospital & Medical School
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
I
2
Arm Description
CKD Stage 3 (estimated GFR 30 - 60 ml/min/1.73m2), Echo LVH
Outcomes
Primary Outcome Measures
Primary objective is to see if Allopurinol reduces left ventricular hypertrophy (LVH) in this group of CKD patients
Secondary Outcome Measures
Secondary objective is to see if Allopurinol reduces endothelial dysfunction in this group of CKD patients
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00688480
Brief Title
Do Xanthine Oxidase Inhibitors Reduce Both Left Ventricular Hypertrophy and Endothelial Dysfunction in Cardiovascular Patients With Renal Dysfunction?
Official Title
Do Xanthine Oxidase Inhibitors Reduce Both Left Ventricular Hypertrophy and Endothelial Dysfunction in Cardiovascular Patients With Renal Dysfunction?
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
August 2009 (Actual)
Study Completion Date
February 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
A. D. Struthers
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Disease, Left Ventricular Hypertrophy
Keywords
CKD, LVH, Echo LVH, Chronic Stage 3
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
67 (Actual)
8. Arms, Groups, and Interventions
Arm Title
I
Arm Type
Placebo Comparator
Arm Description
CKD Stage 3 (estimated GFR 30 - 60 ml/min/1.73m2), Echo LVH
Arm Title
2
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
1 capsule, orally for 9 months
Intervention Type
Drug
Intervention Name(s)
Allopurinol
Intervention Description
Allopurinol 300 mg once/day orally, 9 months
Primary Outcome Measure Information:
Title
Primary objective is to see if Allopurinol reduces left ventricular hypertrophy (LVH) in this group of CKD patients
Time Frame
9 months
Secondary Outcome Measure Information:
Title
Secondary objective is to see if Allopurinol reduces endothelial dysfunction in this group of CKD patients
Time Frame
9 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Allan D Struthers, BSc, MD, FRCP, FESC
Organizational Affiliation
University of Dundee
Official's Role
Principal Investigator
Facility Information:
Facility Name
Division of Medicine and Therapeutics, Ninewells Hospital & Medical School
City
Dundee
ZIP/Postal Code
DD1 9SY
Country
United Kingdom
12. IPD Sharing Statement
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Do Xanthine Oxidase Inhibitors Reduce Both Left Ventricular Hypertrophy and Endothelial Dysfunction in Cardiovascular Patients With Renal Dysfunction?
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