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 https://doi.org/10.1186/ISRCTN73579730
Protocol serial number SR001
Sponsor University of Dundee (UK)
Funder Medical Research Council (UK) (ref: G0701592)
Submission date
23/02/2009
Registration date
05/05/2009
Last edited
29/05/2013
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

Prof Allan Struthers
Scientific

Division of Medicine and Therapeutics
Level 7, Clinical Pharmacology Department
Ninewells Hospital and Medical School
Dundee
DD1 9SY
United Kingdom

Study information

Primary study designInterventional
Study designRandomised double-blind placebo-controlled single-centre trial
Secondary study designRandomised controlled trial
Study type Participant information sheet
Scientific titleDo 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
Study objectivesTo 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(s)Tayside Committee on Medical Research Ethics A, approved on 12/02/2009 (ref: 09/S1401/3)
Health condition(s) or problem(s) studiedNormotensive patients with left ventricular hypertrophy and chronic stable angina
InterventionPatients 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 typeDrug
PhaseNot Applicable
Drug / device / biological / vaccine name(s)Allopurinol
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.

Key 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.

Completion date06/02/2011

Eligibility

Participant type(s)Patient
Age groupAdult
SexAll
Target sample size at registration66
Key inclusion criteria1. 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
Key exclusion criteria1. 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
Date of first enrolment07/02/2009
Date of final enrolment06/02/2011

Locations

Countries of recruitment

  • United Kingdom
  • Scotland

Study participating centre

Division of Medicine and Therapeutics
Dundee
DD1 9SY
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 05/03/2013 Yes No
HRA research summary 28/06/2023 No No
Participant information sheet Participant information sheet 11/11/2025 11/11/2025 No Yes
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