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 |
| Secondary identifying numbers | SR001 |
- 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
Scientific
Division of Medicine and Therapeutics
Level 7, Clinical Pharmacology Department
Ninewells Hospital and Medical School
Dundee
DD1 9SY
United Kingdom
Study information
| Study design | Randomised double-blind placebo-controlled single-centre trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details provided in the Interventions field to request a patient information sheet. |
| 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 |
| Study objectives | 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(s) | Tayside Committee on Medical Research Ethics A, approved on 12/02/2009 (ref: 09/S1401/3) |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | 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 study start date | 07/02/2009 |
| Completion date | 06/02/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 66 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 07/02/2009 |
| Date of final enrolment | 06/02/2011 |
Locations
Countries of recruitment
- Scotland
- United Kingdom
Study participating centre
Division of Medicine and Therapeutics
Dundee
DD1 9SY
United Kingdom
DD1 9SY
United Kingdom
Sponsor information
University of Dundee (UK)
University/education
University/education
c/o James Houston
Research and Development Office
The Nethergate
Dundee
DD1 4HN
Scotland
United Kingdom
| Website | http://www.dundee.ac.uk/ |
|---|---|
"ROR" |
https://ror.org/03h2bxq36 |
Funders
Funder type
Government
Medical Research Council (UK) (ref: G0701592)
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- Medical Research Council (United Kingdom), UK Medical Research Council, MRC
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not 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 |
