The Altered study: Does Allopurinol regress left ventricular hypertrophy in End stage Renal Disease
- Conditions
- Renal failure and left ventricular hypertrophyTherapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- EUCTR2013-001436-22-GB
- Lead Sponsor
- niversity of Dundee/NHS Tayside
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 86
• are aged 18 to 80 years
• end stage renal disease (CKD stage 5 eGFR <15ml/min /1.73m2)
• been on haemodialysis for at least 3 months.
• For main study also require echocardiographic LVH according to the ASE (American Society of Echocardiography) criteria of LVM =115g/m2 for men and >95g/m2 for women.
• All concomitant medication will be allowed and continued unchanged unless clinically indicated during the study.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 60
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 26
• Known heart failure
• Left Ventricular Ejection Fraction <45%,
• already had gout or on allopurinol,
• severe hepatic disease
• or on azathioprine, 6 mercaptopurine, theophylline or warfarin.
• malignancy or other life threatening diseases,
• pregnant or lactating women
• any contraindication to MRI (claustrophobia, metal implants).
• with a planned (relative) kidney transplant,
• Aged less than 18 or over 80 years
• Above ankle amputees
• Patients who have participated in any other clinical trial within the previous 30 days will be excluded.
• Patients who are unable to give informed consent will also be excluded from this trial.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method