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Does a drug allopurinol reduce heart muscle mass and improve blood vessel function in patients with normal blood pressure and stable angina?
ISRCTN ISRCTN73579730
DOI 10.1186/ISRCTN73579730
ClinicalTrials.gov identifier
EudraCT number
Public title Does a drug allopurinol reduce heart muscle mass and improve blood vessel function in patients with normal blood pressure and stable angina?
Scientific title Do xanthine oxidase inhibitors reduce left ventricular hypertrophy and endothelial dysfunction in normotensive patients with chronic stable angina?: a randomised double-blind placebo-controlled single-centre trial
Acronym N/A
Serial number at source SR001
Study hypothesis To assess if allopurinol (a drug currently used to treat gout) reduces left ventricular hypertrophy and improve endothelial dysfunction in patients with normal blood pressure and stable angina.
Lay summary Not provided at time of registration
Ethics approval Tayside Committee on Medical Research Ethics A, approved on 12/02/2009 (ref: 09/S1401/3)
Study design Randomised double-blind placebo-controlled single-centre trial
Countries of recruitment United Kingdom
Disease/condition/study domain Normotensive patients with left ventricular hypertrophy and chronic stable angina
Participants - inclusion criteria 1. Both males and females, adults (No specific age limits)
2. Patients with blood pressure <150/90 mmHg
3. Patients with left ventricular hypertrophy
4. Patients with stable angina
Participants - exclusion criteria 1. Patients with gout or already on allopurinol
2. Patients who have had a previous adverse reaction to allopurinol
3. Patients already on azathioprine
4. Patients with renal dysfunction (estimated glomerular filtration rate (eGFR) <60 ml/min)
5. Patients with heart failure or a left ventricular ejection fraction (LVEF) <45%
6. Patients who have conditions that would exclude them from undergoing an Magnetic Resonance Imaging (MRI) test such as pacemakers or any metal implants in their body
7. Patients who suffer from claustraphobia
8. Patients with cancer or lifethreatening illnesses
9. Patients who are unable to provide informed consent (e.g., learning disabilities)
10. Pregnancy or breastfeeding patients
Anticipated start date 07/02/2009
Anticipated end date 06/02/2011
Status of trial Completed
Patient information material Not available in web format, please use the contact details provided in the Interventions field to request a patient information sheet.
Target number of participants 66
Interventions Patients will be given either allopurinol or placebo once a day orally. Patients will be given 100 mg for the first 2 weeks and then increased to 300 mg which is to be continued for further 4 weeks. Dosage will then be increased to 600 mg which is continue for a further 46 weeks (Total duration of interventions: 1 year).

Please use the following contact details to request a patient information sheet:
Dr Sushma Rekhraj
Clinical Research Fellow
Department of Clinical Pharmacology
Ninewells Hospital and Medical School
Dundee, DD1 9SY
United Kingdom
Primary outcome measure(s) To assess left ventricular mass regression. This will be measured by cardiac MRI at baseline and then repeated after 1 year.
Secondary outcome measure(s) 1. To assess endothelial function. This will be done by flow mediated dilatation and spygmocor. This will be performed at baseline, 6 months and then 1 year.
2. To assess if allopurinol reduces arrhythmogenicity. This will be done by looking at microvolt T wave alternans on electrocardiogram (ECG) at baseline and 1 year.
Sources of funding Medical Research Council (UK) (ref: G0701592)
Trial website
Publications 1. 2013 results in http://www.ncbi.nlm.nih.gov/pubmed/23449426
Contact name Prof  Allan  Struthers
  Address Division of Medicine and Therapeutics
Level 7, Clinical Pharmacology Department
Ninewells Hospital and Medical School
  City/town Dundee
  Zip/Postcode DD1 9SY
  Country United Kingdom
Sponsor University of Dundee (UK)
  Address c/o James Houston
Research and Development Office
The Nethergate
  City/town Dundee
  Zip/Postcode DD1 4HN
  Country United Kingdom
  Sponsor website: http://www.dundee.ac.uk/
Date applied 23/02/2009
Last edited 29/05/2013
Date ISRCTN assigned 05/05/2009
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