Does ALlopurinol Regress lefT Ventricular Hypertrophy in End Stage REnal Disease: The ALTERED Study
Status:
Completed
Trial end date:
2016-08-01
Target enrollment:
Participant gender:
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
Details
Lead Sponsor:
University of Dundee
Collaborators:
British Heart Foundation NHS Greater Glasgow and Clyde NHS Tayside University of Glasgow