Do xanthine oxidase inhibitors reduce both left ventricular hypertrophy and endothelial dysfunction in cardiovascular patients with renal dysfunction?
| ISRCTN | ISRCTN45773760 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN45773760 |
| EudraCT/CTIS number | 2007-004760-49 |
| Secondary identifying numbers | MK001 |
- Submission date
- 28/05/2008
- Registration date
- 26/06/2008
- Last edited
- 14/09/2011
- 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
Dr Michelle Kao
Scientific
Scientific
Division of Medicine and Therapeutics
Level 7
Ninewells Hospital and Medical School
University of Dundee
Dundee
DD1 9SY
United Kingdom
| Phone | +44 (0)1382 496440 |
|---|---|
| m.kao@dundee.ac.uk |
Study information
| Study design | Randomised, double-blind, placebo-controlled trial. |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | |
| Study objectives | Patients with chronic kidney disease (CKD) mainly die from cardiovascular-related causes, with a mortality 20 times the risk of a general population. Although all the traditional risk factors are accountable, studies show that oxidative stress makes a particular contribution to the excessive cardiovascular risks. Oxidative stress promotes left ventricular hypertrophy (LVH) and causes endothelial dysfunction. LVH is known to be an independent predictor of cardiovascular events and studies have shown the survival benefits of regressing LVH. Allopurinol has been proven to be a potent antioxidant. Hence, this study looks to see if allopurinol would regress LVH and also improve endothelial dysfunction in patients with CKD. |
| Ethics approval(s) | Tayside Committee on Medical Research Ethics A. Date of approval: 05/12/2007 (ref: 07/S1401/132) |
| Health condition(s) or problem(s) studied | Chronic kidney disease (CKD) and left ventricular hypertrophy (LVH) |
| Intervention | Allopurinol 300 mg vs placebo once a day orally for 9 months |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | allopurinol |
| Primary outcome measure | Reduction in left ventricular hypertrophy at 9 months |
| Secondary outcome measures | Reduction in endothelial dysfunction at 9 months |
| Overall study start date | 15/01/2008 |
| Completion date | 31/10/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 60 |
| Key inclusion criteria | 1. Both males and females, age >18 years old and there is no upper age limit 2. Chronic kidney disease, Stage 3 (estimated glomerular filtration rate [GFR] 30-60 ml/min) 3. Echo left ventricular hypertrophy |
| Key exclusion criteria | 1. Known cardiac failure with left ventricular ejection fraction (LVEF) <45% 2. Patients already on allopurinol 3. Patients who have gout 4. Patients with severe hepatic disease 5. Usual contraindications to magnetic resonance imaging (MRI), including any metal implants in the body and severe claustrophobia 6. Current immunosuppressive therapy (e.g., azathioprine, ciclosporin or cyclophosphamide), chlorpropamide, theophylline or 6-mercaptopurine 7. Malignancy or other life threatening disease 8. Pregnancy and lactating women 9. Patients unable to provide informed consent (e.g., learning difficulties) |
| Date of first enrolment | 15/01/2008 |
| Date of final enrolment | 31/10/2009 |
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
R and D Office
University of Dundee
11 Perth Road
Dundee
DD1 4HN
Scotland
United Kingdom
| Phone | +44 (0)1382 384664 |
|---|---|
| j.z.houston@dundee.ac.uk | |
| Website | http://www.dundee.ac.uk |
"ROR" |
https://ror.org/03h2bxq36 |
Funders
Funder type
Charity
British Heart Foundation (UK)
Private sector organisation / Trusts, charities, foundations (both public and private)
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- the_bhf, The British Heart Foundation, BHF
- 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 | 01/07/2011 | Yes | No |
