Contact information
Type
Scientific
Primary contact
Dr Jacob George
ORCID ID
Contact details
Deparment of Clinical Pharmacology
Level 7
Ninewells Hospital
Dundee
DD1 9SY
United Kingdom
+44 (0)1382 660111 ext 33176
j.george@dundee.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
EudraCT number 2004-001087-51
Study information
Scientific title
Acronym
GEO 002
Study hypothesis
Uric acid lowering by another mechanism (uricosuria) would elucidate whether allopurinol primarily improves endothelial function because of its ability to reduce urate effectively
Ethics approval
Ethics approval obtained, ref no 04/S1401/66
Study design
Randomised placebo-controlled double blind crossover trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Chronic Heart Failure
Intervention
Probenecid 1000 mg versus placebo
Intervention type
Drug
Phase
Not Specified
Drug names
Probenecid
Allopurinol
Primary outcome measures
Forearm blood flow
Secondary outcome measures
1. Oxidative stress burden
2. Urate levels
Overall trial start date
02/03/2005
Overall trial end date
15/05/2006
Reason abandoned
Eligibility
Participant inclusion criteria
1. Three-month period free of hospitalisations prior to screening
2. Ability to give written informed consent to participate in the study
3. Diagnosis of mild to moderate chronic heart failure
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
30
Participant exclusion criteria
1. History of drug sensitivity or allergy to probenecid or vitamin C
2. Current treatment with probenecid, allopurinol, theophylline, warfarin or cytotoxic drugs (including azothiaprine or mercaptopurine)
3. History of acute gout or porphyria
4. Evidence of significant disease that could impair absorption, metabolism or excretion of orally-administered medication i.e.
a. Renal disease (serum creatinine 180 umol/l)
b. Clinically significant hepatic disease (either by lab work, i.e. alanine aminotranferease (ALT) and aspartate aminotransferase (AST) (ALT/AST > 3 times upper limit of normal, or by clinical assessment)
5. Any condition with sufficient severity to impair co-operation in the study
6. History of chronic alcoholism / intravenous drug abuse
7. Use of another investigational drug within three months of entry into the study or within five half-lives of the investigational drug (the longer time period applying)
8. Pregnancy, breast feeding or being of childbearing age and not taking oral contraceptives, all pre-menopausal women will be required to undergo a pregnancy test
9. Patients on aspirin doses greater than 150 mg/day
Recruitment start date
02/03/2005
Recruitment end date
15/05/2006
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Deparment of Clinical Pharmacology
Dundee
DD1 9SY
United Kingdom
Sponsor information
Organisation
University of Dundee (UK)
Sponsor details
Research and Innovation Services
University of Dundee
Dundee
DD1 4HN
United Kingdom
+44 (0)1382 344664
research@dundee.ac.uk
Sponsor type
Research organisation
Website
Funders
Funder type
Charity
Funder name
British Heart Foundation funded project (PG/03/060) (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2006 results in http://www.ncbi.nlm.nih.gov/pubmed/17130343
Publication citations
-
Results
George J, Carr E, Davies J, Belch JJ, Struthers A, High-dose allopurinol improves endothelial function by profoundly reducing vascular oxidative stress and not by lowering uric acid., Circulation, 2006, 114, 23, 2508-2516, doi: 10.1161/CIRCULATIONAHA.106.651117.