GEO 001: What is the dose-response curve between allopurinol and its effects on endothelial function in heart failure patients?
ISRCTN | ISRCTN44536106 |
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DOI | https://doi.org/10.1186/ISRCTN44536106 |
Secondary identifying numbers | 242/03 |
- Submission date
- 25/01/2006
- Registration date
- 27/01/2006
- Last edited
- 16/12/2010
- 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
Department of Clinical Pharmacology
Level 7
Ninewells Hospital
Dundee
DD1 9SY
United Kingdom
Phone | +44 (0)1382 660111 ext 33176 |
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j.george@dundee.ac.uk |
Study information
Study design | Randomised, placebo-controlled, double blind, crossover trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Not specified |
Study type | Treatment |
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 |
Pharmaceutical study type(s) | |
Phase | Not Specified |
Drug / device / biological / vaccine name(s) | Allopurinol |
Primary outcome measure | Improvement in endothelial function |
Secondary outcome measures | Urate levels and oxidative stress burden |
Overall study start date | 05/02/2004 |
Completion date | 29/08/2005 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Sex | Both |
Target number of participants | 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 |
Locations
Countries of recruitment
- Scotland
- United Kingdom
Study participating centre
Department of Clinical Pharmacology
Dundee
DD1 9SY
United Kingdom
DD1 9SY
United Kingdom
Sponsor information
University of Dundee (UK)
University/education
University/education
Research and Innovation Services
University of Dundee
Dundee
DD1 4HN
Scotland
United Kingdom
Phone | +44 (0)1382 344664 |
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research@dundee.ac.uk | |
https://ror.org/03h2bxq36 |
Funders
Funder type
Charity
British Heart Foundation funded project PG 03/060
No information available
Results and Publications
Intention to publish date | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
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Results article | results | 05/12/2006 | Yes | No |