GEO 002: Is a reduction in urate levels the mechanism by which allopurinol improves endothelial function?
| ISRCTN | ISRCTN32422978 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN32422978 |
| Protocol serial number | EudraCT number 2004-001087-51 |
| Sponsor | University of Dundee (UK) |
| Funder | British Heart Foundation funded project (PG/03/060) (UK) |
- Submission date
- 25/01/2006
- Registration date
- 27/01/2006
- Last edited
- 01/03/2010
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Jacob George
Scientific
Scientific
Deparment of Clinical Pharmacology
Level 7
Ninewells Hospital
Dundee
DD1 9SY
United Kingdom
| Phone | +44 (0)1382 660111 ext 33176 |
|---|---|
| j.george@dundee.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised placebo-controlled double blind crossover trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study acronym | GEO 002 |
| Study objectives | 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(s) | Ethics approval obtained, ref no 04/S1401/66 |
| Health condition(s) or problem(s) studied | Chronic Heart Failure |
| Intervention | Probenecid 1000 mg versus placebo |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Probenecid Allopurinol |
| Primary outcome measure(s) | Forearm blood flow |
| Key secondary outcome measure(s) | 1. Oxidative stress burden 2. Urate levels |
| Completion date | 15/05/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 30 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 02/03/2005 |
| Date of final enrolment | 15/05/2006 |
Locations
Countries of recruitment
- United Kingdom
- Scotland
Study participating centre
Deparment of Clinical Pharmacology
Dundee
DD1 9SY
United Kingdom
DD1 9SY
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 05/12/2006 | Yes | No |
