| Trial ID: | L1331 |
| Source ID: | NCT01951404
|
| Associated Drug: |
Allopurinol
|
| Title: |
Does ALlopurinol Regress lefT Ventricular Hypertrophy in End Stage REnal Disease: The ALTERED Study
|
| Acronym: |
Altered
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
End Stage Renal Disease|Left Ventricular Hypertrophy
|
| Interventions: |
DRUG: Allopurinol|DRUG: Placebo (for allopurinol)
|
| Outcome Measures: |
Primary: The primary outcome is to measure if allopurinol, induces a change in Left ventricular Mass Index in patients with ESRD when compared to placebo., following 1 year of therapy | Secondary: To decide on optimum dosing regime of allopurinol in End Stage Renal Disease from pilot study, The dose of allopurinol required to reduce urate levels by 41% will be determined., 6 weeks|To measure any difference in endothelial function with allopurinol compared with placebo, measured by Flow Mediated Dilatation and Pulse Wave Analysis, 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, 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., Following 1 year of therapy|To measure changes in inflammatory blood markers, in ESRD with allopurinol compared with placebo., 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, Following 1 year of therapy
|
| Sponsor/Collaborators: |
Sponsor: University of Dundee | Collaborators: British Heart Foundation|NHS Tayside|NHS Greater Glasgow and Clyde|University of Glasgow
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
80
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2013-09
|
| Completion Date: |
2016-08
|
| Results First Posted: |
|
| Last Update Posted: |
2016-11-04
|
| Locations: |
NHS Greater Glasgow and Clyde, Glasgow, La, G12 8TA, United Kingdom|NHS Tayside, Dundee, Tayside, DD9 1SY, United Kingdom|NHS Ayrshire and Arran, Crosshouse, KA2OBE, United Kingdom
|
| URL: |
https://clinicaltrials.gov/show/NCT01951404
|
