GEO 001: What is the dose-response curve between allopurinol and its effects on endothelial function in heart failure patients?

ISRCTN	ISRCTN44536106
DOI	https://doi.org/10.1186/ISRCTN44536106
Protocol serial number	242/03
Sponsor	University of Dundee (UK)
Funder	British Heart Foundation funded project PG 03/060

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Jacob George
Scientific

Department 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

Primary study design	Interventional
Study design	Randomised, placebo-controlled, double blind, crossover trial
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	GEO 001
Study objectives	High dose (600 mg) allopurinol improves endothelial function significantly more than the regular 300 mg dose
Ethics approval(s)	Ethics ref no: 242/03 (application is retrospective, trial is already complete and ethics approval was gained)
Health condition(s) or problem(s) studied	Chronic Heart Failure
Intervention	Allopurinol 300 mg versus allopurinol 600 mg versus placebo
Intervention type	Drug
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Allopurinol
Primary outcome measure(s)	Improvement in endothelial function
Key secondary outcome measure(s)	Urate levels and oxidative stress burden
Completion date	29/08/2005

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 allopurinol or vitamin C 2. Current treatment with allopurinol , theophylline or cytotoxic drugs (including azothiaprine or mercaptopurine) 3. History of acute gout 4. Evidence of significant disease that could impair absorption, metabolism or excretion of orally administered medication i.e. a. Renal disease (serum creatinine >160 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
Date of first enrolment	05/02/2004
Date of final enrolment	29/08/2005

Department of Clinical Pharmacology

Dundee
DD1 9SY
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	05/12/2006		Yes	No