Hypertension Clinical Trial
Official title:
Uric Acid and Hypertension in African Americans
This study will test the hypothesis that the administration of a xanthine oxidase inhibitor (allopurinol) will prevent thiazide-induced hyperuricemia, which will result in better blood pressure (BP) control in African Americans.
Thiazide diuretics when used in the treatment of hypertension are associated with many
metabolic side effects, including hyperuricemia, gout, insulin resistance, and
hyperlipidemia. Each of these conditions is already highly prevalent in African Americans.
Our hypothesis is that thiazide-induced hyperuricemia decreases the efficacy of thiazides in
controlling BP, leads to endothelial dysfunction, and increases the incidence of insulin
resistance and impaired glucose tolerance. This hypothesis will be tested in a randomized,
double-blind, placebo-controlled clinical trial of 8-10 weeks duration in which a total of
100 African American patients with hypertension will be enrolled, randomized, and treated as
follows:
1. Subjects with untreated stage I hypertension will receive chlorthalidone (25 mg/day) and
potassium chloride (40 mEq/day) for 4 weeks. Serum potassium levels will be obtained
after four weeks on chlorthalidone. If the level is below 3.5 mEg/L, a bolus of 40 mEq
potassium 2 to 3 times daily will be given for 2 to 3 days, or as clinically indicated.
A maintenance dose of 50 mEq will be initiated. After at least 7 days, they will then be
randomized to add-on allopurinol (300 mg/day) or placebo. Treatment will continue for
8-10 weeks with the chlorthalidone, potassium chloride, and allopurinol/placebo regimen.
2. Subjects with hypertension controlled (i.e. BP <140/90) or no higher than stage 1
hypertension (i.e., <160/100) on a single antihypertensive agent or two antihypertensive
agents will be switched from their prior antihypertensive agent to chlorthalidone 25
mg/day, and potassium chloride (40mEq/day) for 4 weeks. Serum potassium levels will be
obtained after four weeks on chlorthalidone. If the level is below 3.5 mEg/L, a bolus of
40 mEq potassium 2 to 3 times daily will be given for 2 to 3 days, or as clinically
indicated. A maintenance dose of 50 mEq will be initiated. After at least 7 days, they
will then be randomized to add-on allopurinol (300 mg/day) or placebo. Treatment will
continue for 8-10 weeks with the chlorthalidone, potassium chloride, and
allopurinol/placebo regimen.
The allopurinol (or placebo) dose will be adjusted to achieve serum uric acid levels between
4 and 5.5 mg/dL after 2 weeks on drug. All subjects will receive a low-sodium diet. The
primary endpoint is reduction in systolic BP. Secondary endpoints measure endothelial
function, ambulatory blood pressure, body composition, systemic inflammation, metabolic
parameters, oxidant stress, and renal hemodynamics.
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