Febuxostat, Blood Pressure and the Intrarenal Renin-Angiotensin System (RAS)
In this study the investigators will recruit hypertensive subjects with higher than average uric acid levels to test the effect of lowering uric acid with febuxostat on several measures as listed below. This will be a randomized, double-blind, placebo-controlled, parallel group study.
1. To examine the effects of febuxostat on the activity of the intrarenal renin-angiotensin system as measured indirectly by renal plasma flow response to infused Ang II.
- To examine the effects of febuxostat on proximal and distal tubular sodium excretion as estimated by uric acid clearance and sodium clearance.
- To determine effects of febuxostat on endothelial function in hypertensive subjects with higher than average uric acid.
- To determine effect of febuxostat on blood pressure (by 24-hour ambulatory monitoring).
3. To examine the correlation between change in uric acid and changes in inflammatory markers including High-Sensitivity C-Reactive Protein and (optionally) other markers of endothelial activation including soluble Intercellular Adhesion Molecule, Vascular Endothelial Cell Adhesion Molecule and Mast Cell Progenitor.
|Study Design:||Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
|Official Title:||Febuxostat, Blood Pressure and the Intrarenal Renin-Angiotensin System (RAS)|
- Change in renal plasma flow in response to infused angiotensin II [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- Change in endothelial function [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||March 2011|
|Study Completion Date:||January 2014|
|Primary Completion Date:||September 2013 (Final data collection date for primary outcome measure)|
|Placebo Comparator: Febuxostat||
This will be a randomized, double-blind, placebo-controlled, parallel group trial. Baseline measurements will be performed initially off all antihypertensive medication and without study medication. Subjects will then be randomized to febuxostat or placebo, treated for 6 weeks, and baseline measurements will then be repeated to assess change from baseline.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01328769
|United States, Utah|
|Cardiovascular Genetics, University of Utah|
|Salt Lake City, Utah, United States, 84108|
|Principal Investigator:||Paul N Hopkins||Cardiovascular Genetics|