Does ALlopurinol Regress lefT Ventricular Hypertrophy in End Stage REnal Disease: The ALTERED Study

• Status: Completed
• Trial end date: 2016-08-01
• Target enrollment: 0
• Participant gender: All

Summary

Kidney patients on dialysis commonly die because of heart disease. One of the biggest problems in their hearts is that the muscle wall of the heart thickens. This makes it less efficient. We found in patients with mild kidney disease that a drug normally used to treat gout (allopurinol) had the remarkable side effect of being able to reduce this thickening of their heart wall. In this new study we aim to find out if this benefit of allopurinol also occurs in severe kidney patients i.e. those on regular dialysis. We also are trying to figure out the best dose of allopurinol to use. To do this we are planning a study where we will recruit patients with kidney disease who are on dialysis. The 1st phase of the trial will be to determine the best dose of allopurinol to use and the second phase will be to do a clinical trial where patients will be randomly allocated to either this optimum dose of allopurinol or a dummy medication (placebo) and will receive one year of treatment. They will have a special scan of the heart using an MRI machine to measure the extent of thickening of their heart muscle before they start on treatment and will have a further MRI scan when their one year treatment finishes.

Phase 1- the dose finding study, will involve 10 patients who will have between 3 and 7 visits to the hospital scheduled around 4 to 17 dialysis sessions. The later study will involve up to 76 patients who will be asked to attend the hospital up to 8 times over a 13 month period.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Dundee
• Collaborators: British Heart Foundation; NHS Greater Glasgow and Clyde; NHS Tayside; University of Glasgow
• Treatments: Allopurinol

Criteria

Inclusion Criteria:

• aged 18 years or over

• end stage renal disease (CKD stage 5 eGFR <15ml/min /1.73m2)

• been on haemodialysis for at least 3 months.

Exclusion Criteria:

• Known heart failure

• Left Ventricular Ejection Fraction <45%,

• active gout

• severe hepatic disease

• or on azathioprine, 6 mercaptopurine, theophylline.

• malignancy or other life threatening diseases,

• pregnant or lactating women

• any contraindication to MRI (claustrophobia, metal implants).

• with a planned (relative) kidney transplant,

• 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.

• Any other considered by a study physician to be inappropriate for inclusion