Does ALlopurinol Regress lefT Ventricular Hypertrophy in End Stage REnal Disease: The ALTERED Study (Altered)
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|ClinicalTrials.gov Identifier: NCT01951404|
Recruitment Status : Completed
First Posted : September 26, 2013
Last Update Posted : November 4, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|End Stage Renal Disease Left Ventricular Hypertrophy||Drug: Allopurinol Drug: Placebo (for allopurinol)||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Does ALlopurinol Regress lefT Ventricular Hypertrophy in End Stage REnal Disease: The ALTERED Study|
|Study Start Date :||September 2013|
|Actual Primary Completion Date :||August 2016|
|Actual Study Completion Date :||August 2016|
Active Comparator: Allopurinol
Participants in this arm will be given allopurinol with the dose gradually increasing weekly as tolerated up to the dose determined in the first phase of the study. The drug dose will be given orally 3 times weekly after dialysis for 1 year.
Placebo Comparator: Placebo
Participants in this arm will be given placebo with the dose appearing to gradually increase weekly as tolerated up to the dose determined in the first phase of the study. The drug dose will be given orally 3 times weekly after dialysis for 1 year.
Drug: Placebo (for allopurinol)
- The primary outcome is to measure if allopurinol, induces a change in Left ventricular Mass Index in patients with ESRD when compared to placebo. [ Time Frame: following 1 year of therapy ]
- To decide on optimum dosing regime of allopurinol in End Stage Renal Disease from pilot study [ Time Frame: 6 weeks ]The dose of allopurinol required to reduce urate levels by 41% will be determined.
- To measure any difference in endothelial function with allopurinol compared with placebo, measured by Flow Mediated Dilatation and Pulse Wave Analysis [ Time Frame: following 1 year of therapy ]
- To assess if the incidence of adverse events differs on allopurinol compared to placebo in patients with end stage renal disease [ Time Frame: during course of 1 year of therapy ]
- To measure any change in LV end systolic volume, LV end diastolic volume or LV ejection factor with allopurinol in ESRD patients compared with placebo. [ Time Frame: Following 1 year of therapy ]
- To measure changes in inflammatory blood markers, in ESRD with allopurinol compared with placebo. [ Time Frame: Following 1 year of therapy ]
- To measure changes in BP control as measured by clinic BP and 24hr BP monitoring with allopurinol compared with placebo [ Time Frame: Following 1 year of therapy ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01951404
|NHS Greater Glasgow and Clyde|
|Glasgow, La, United Kingdom, G12 8TA|
|Dundee, Tayside, United Kingdom, DD9 1SY|
|NHS Ayrshire and Arran|
|Crosshouse, United Kingdom, KA2OBE|
|Study Director:||Allan D Struthers, BSc, MD, FRCP, FESC, FRSE||Centre for Cadiovascular Medicine, University of Dundee|