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
Secondary identifying numbers EudraCT number 2004-001087-51
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

Deparment of Clinical Pharmacology
Level 7
Ninewells Hospital
Dundee
DD1 9SY
United Kingdom

Phone +44 (0)1382 660111 ext 33176
Email j.george@dundee.ac.uk

Study information

Study designRandomised placebo-controlled double blind crossover trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific title
Study acronymGEO 002
Study objectivesUric 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) studiedChronic Heart Failure
InterventionProbenecid 1000 mg versus placebo
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Probenecid Allopurinol
Primary outcome measureForearm blood flow
Secondary outcome measures1. Oxidative stress burden
2. Urate levels
Overall study start date02/03/2005
Completion date15/05/2006

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants30
Key inclusion criteria1. 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 criteria1. 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 enrolment02/03/2005
Date of final enrolment15/05/2006

Locations

Countries of recruitment

  • Scotland
  • United Kingdom

Study participating centre

Deparment of Clinical Pharmacology
Dundee
DD1 9SY
United Kingdom

Sponsor information

University of Dundee (UK)
Research organisation

Research and Innovation Services
University of Dundee
Dundee
DD1 4HN
United Kingdom

Phone +44 (0)1382 344664
Email research@dundee.ac.uk
ROR logo "ROR" https://ror.org/03h2bxq36

Funders

Funder type

Charity

British Heart Foundation funded project (PG/03/060) (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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