Condition category
Circulatory System
Date applied
23/02/2009
Date assigned
05/05/2009
Last edited
29/05/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Allan Struthers

ORCID ID

Contact details

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

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 measures

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

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

http://www.dundee.ac.uk/

Funders

Funder type

Government

Funder name

Medical Research Council (UK) (ref: G0701592)

Alternative name(s)

MRC

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

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

Results - basic reporting

Publication summary

1. 2013 results in http://www.ncbi.nlm.nih.gov/pubmed/23449426

Publication citations

  1. 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.

Additional files

Editorial Notes