Status:
COMPLETED
Uric Acid and Hypertension in African Americans
Lead Sponsor:
University of Florida
Conditions:
Cardiovascular Diseases
Heart Diseases
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
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) c...
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 cond...
Eligibility Criteria
Inclusion
- African American (including black individuals born in the Caribbean, Africa, Canada, etc.)
- Are either untreated with any antihypertensive agent, with an average sitting clinic BP of between 140/90 and 159/99 mm Hg OR subjects with hypertension controlled (i.e. BP less than 140/90) or no higher than stage 1 hypertension (i.e., less than 160/100) on a single antihypertensive agent or two antihypertensive agents (individuals on fixed dose ARB-diuretic or ACEI-diuretic combinations will also be considered as being on monotherapy for purposes of the study. Individuals on beta blockade or calcium channel blockade for coronary artery disease and/or arrhythmia will not be eligible for the study)
- Random spot urine protein/creatinine ratio of less than 0.5 (approximates a 24-hour urinary protein excretion of 500 mg/day)
- Calculated MDRD GFR of greater than or equal to 60 ml/min/1.73/m\^2
- No allopurinol or probenecid intake for at least one month prior to study entry
- Willing and able to cooperate with study procedures
- Willing to travel to the GCRC at Shands Hospital for overnight inpatient stays on two separate occasions
Exclusion
- History of malignant or accelerated hypertension
- Confirmed total white cell count of less than 2,500/mm\^3, anemia, or thrombocytopenia
- Known history of liver disease
- Known secondary cause of hypertension
- Known presence of diabetes or fasting blood glucose greater than or equal to 126 mg/dL
- History of heart failure, acute myocardial infarction, or stroke or on a β-blocker or calcium channel blocker for cardiovascular indications other than for lowering blood pressure
- Abnormal EKG requiring medical intervention
- History of clinical or renal biopsy or evidence of renal parenchymal disease
- Acute gout attack within 2 weeks of study entry
- History of drug abuse in the last 2 years, including narcotics, cocaine, or alcohol (greater than 21 drinks/week)
- Arm circumference of greater than 52 cm, which precludes measurement with a 'thigh' BP cuff
- History of a reaction to allopurinol or chlorthalidone
- Pregnant or planning to become pregnant during the study, or breastfeeding
- History of noncompliance, are unable to comply with the study requirements, or who are currently participating in another study
- Not fasting prior to obtaining screening laboratory data. If a participant has clearly not fasted, we will exclude those individuals with casual blood glucose levels of greater than or equal to 200 mg/dL. In the event that a fasting blood sugar exceeds 126 mg/dL, it will be reconfirmed on a blood glucose measurement obtained on a subsequent day, per American Diabetes Association criteria
Key Trial Info
Start Date :
August 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2011
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT00241839
Start Date
August 1 2005
End Date
May 1 2011
Last Update
July 26 2013
Active Locations (1)
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1
University of Florida
Gainesville, Florida, United States, 32610