MedDataX Logo

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

NCT ID: NCT00688480

Last Updated: 2016-11-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

67 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2010-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Kidney Disease Left Ventricular Hypertrophy

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

CKD LVH Echo LVH Chronic Stage 3

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

I

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

1 capsule, orally for 9 months

2

Group Type ACTIVE_COMPARATOR

Allopurinol

Intervention Type DRUG

Allopurinol 300 mg once/day orally, 9 months

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Placebo

1 capsule, orally for 9 months

Intervention Type DRUG

Allopurinol

Allopurinol 300 mg once/day orally, 9 months

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

A. D. Struthers

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

A. D. Struthers

Head Of Cardiovascular and Diabetes Medicine

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Allan D Struthers, BSc, MD, FRCP, FESC

Role: PRINCIPAL_INVESTIGATOR

University of Dundee

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Division of Medicine and Therapeutics, Ninewells Hospital & Medical School

Dundee, , United Kingdom

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United Kingdom

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

MK001

Identifier Type: -

Identifier Source: org_study_id