Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
SR001
Study information
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
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.
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
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details provided in the Interventions field to request a patient information sheet.
Condition
Normotensive patients with left ventricular hypertrophy and chronic stable angina
Intervention
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
Intervention type
Drug
Phase
Not Applicable
Drug names
Allopurinol
Primary outcome measure
To assess left ventricular mass regression. This will be measured by cardiac MRI at baseline and then repeated after 1 year.
Secondary outcome measures
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.
Overall trial start date
07/02/2009
Overall trial end date
06/02/2011
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
66
Participant 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
Recruitment start date
07/02/2009
Recruitment end date
06/02/2011
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Division of Medicine and Therapeutics
Dundee
DD1 9SY
United Kingdom
Sponsor information
Organisation
University of Dundee (UK)
Sponsor details
c/o James Houston
Research and Development Office
The Nethergate
Dundee
DD1 4HN
United Kingdom
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
Medical Research Council (UK) (ref: G0701592)
Alternative name(s)
MRC
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
1. 2013 results in http://www.ncbi.nlm.nih.gov/pubmed/23449426
Publication citations
-
Results
Rekhraj S, Gandy SJ, Szwejkowski BR, Nadir MA, Noman A, Houston JG, Lang CC, George J, Struthers AD, High-dose allopurinol reduces left ventricular mass in patients with ischemic heart disease., J. Am. Coll. Cardiol., 2013, 61, 9, 926-932, doi: 10.1016/j.jacc.2012.09.066.