Ignite Creation Date:
2024-05-05 @ 12:07 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00241839
Status:
COMPLETED
Last Update Posted:
2013-07-26
First Post:
2005-10-17
Brief Title:
Uric Acid and Hypertension in African Americans
Sponsor:
University of Florida
Organization:
University of Florida
Study Overview
Official Title:
Uric Acid and Hypertension in African Americans
Status:
COMPLETED
Status Verified Date:
2013-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
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 mgday and potassium chloride 40 mEqday for 4 weeks Serum potassium levels will be obtained after four weeks on chlorthalidone If the level is below 35 mEgL 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 mgday or placebo Treatment will continue for 8-10 weeks with the chlorthalidone potassium chloride and allopurinolplacebo regimen
2 Subjects with hypertension controlled ie BP 14090 or no higher than stage 1 hypertension ie 160100 on a single antihypertensive agent or two antihypertensive agents will be switched from their prior antihypertensive agent to chlorthalidone 25 mgday and potassium chloride 40mEqday for 4 weeks Serum potassium levels will be obtained after four weeks on chlorthalidone If the level is below 35 mEgL 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 mgday or placebo Treatment will continue for 8-10 weeks with the chlorthalidone potassium chloride and allopurinolplacebo regimen
The allopurinol or placebo dose will be adjusted to achieve serum uric acid levels between 4 and 55 mgdL 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
1 Subjects with untreated stage I hypertension will receive chlorthalidone 25 mgday and potassium chloride 40 mEqday for 4 weeks Serum potassium levels will be obtained after four weeks on chlorthalidone If the level is below 35 mEgL 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 mgday or placebo Treatment will continue for 8-10 weeks with the chlorthalidone potassium chloride and allopurinolplacebo regimen
2 Subjects with hypertension controlled ie BP 14090 or no higher than stage 1 hypertension ie 160100 on a single antihypertensive agent or two antihypertensive agents will be switched from their prior antihypertensive agent to chlorthalidone 25 mgday and potassium chloride 40mEqday for 4 weeks Serum potassium levels will be obtained after four weeks on chlorthalidone If the level is below 35 mEgL 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 mgday or placebo Treatment will continue for 8-10 weeks with the chlorthalidone potassium chloride and allopurinolplacebo regimen
The allopurinol or placebo dose will be adjusted to achieve serum uric acid levels between 4 and 55 mgdL 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01HL079352 | NIH | None | httpsreporternihgovquickSearchR01HL079352 |