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
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

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

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 001
Study objectivesHigh 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) studiedChronic Heart Failure
InterventionAllopurinol 300 mg versus allopurinol 600 mg versus placebo
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Allopurinol
Primary outcome measureImprovement in endothelial function
Secondary outcome measuresUrate levels and oxidative stress burden
Overall study start date05/02/2004
Completion date29/08/2005

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 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 enrolment05/02/2004
Date of final enrolment29/08/2005

Locations

Countries of recruitment

  • Scotland
  • United Kingdom

Study participating centre

Department of Clinical Pharmacology
Dundee
DD1 9SY
United Kingdom

Sponsor information

University of Dundee (UK)
University/education

Research and Innovation Services
University of Dundee
Dundee
DD1 4HN
Scotland
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

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