Center of Research Translation (CORT) Project 2

The University of Alabama at Birmingham

Status and phase: Completed; Phase 3; Phase 2

Conditions: JNC 7 Stage I Hypertension; Pre-hypertension

Treatments: Drug: Allopurinol; Drug: Placebo

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02038179

P50AR060772 (U.S. NIH Grant/Contract)

F130408004

Details and patient eligibility

About

We propose a novel intervention for reducing BP that could have a preferential impact in patients with hyperuricemia and gout. There is a great need for new anti-hypertensives, particularly among those with gout. The proposed study is novel in its plans to investigate the physiologic mechanisms through which urate contributes to vascular disease and by which ULT may contribute to BP reduction. Also innovative, we will: 1) determine to what extent the described benefit of lowering serum urate extends beyond the adolescent population previously studied into young adults, 2) test whether a urate-lowering approach will benefit individuals that do not yet meet the current definition of hyperuricemia and do not have gout, and 3) begin to explore potential mechanisms for the higher prevalence of hypertension among African-Americans. If successful, this work could translate to the standard of clinical care and to health care recommendations for the population as a whole.

Enrollment: 99 patients

Sex: All

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Pre-hypertension or stage I hypertension, defined as the following after the mean of two clinic measurements:
• Systolic blood pressure (SBP) ≥ 120 and <160 or;
• Diastolic blood pressure (DBP) ≥ 80 and < 100
• Serum urate ≥ 5.0 mg/dL for men or ≥ 4.0 mg/dL for women
• Age 18-40

Exclusion criteria

• Any current pharmacological treatment for hypertension, including diuretics (calcium channel blockers at stable doses were later allowed)
• Estimated glomerular filtration rate < 60 mL/min/1.73m2
• Current use of any urate-lowering therapy or statins
• Prior diagnosis of gout or past use of urate-lowering therapy for gout
• Prior diagnosis of diabetes
• Pregnancy, or recent delivery or last trimester pregnancy loss more recent than 3 months
• Active smokers
• Immune-suppressed individuals including transplant recipients or current use of azathioprine.
• Leucopenia with absolute white cell count < 3000 /mL, anemia with hemoglobin < 12 g/dL, or thrombocytopenia with platelet count < 150,000/mL
• Individuals of Han Chinese or Thai descent with HLAB5801 genetic phenotype
• Serious medical condition that at investigator's judgment precludes utilization of a fixed dose of allopurinol

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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99 participants in 2 patient groups

Allopurinol, Then Placebo

Experimental group

Description:

Participants will be asked to take 4 weeks of allopurinol (300 mg oral per day), then will crossover (after 2-4 week washout period) and take placebo for an additional 4 weeks.

Treatment:

Drug: Allopurinol

Drug: Placebo

Placebo, Then Allopurinol

Experimental group

Description:

Participants will be asked to take 4 weeks of placebo, then will crossover (after 2-4 week washout period) and take allopurinol (300 mg oral per day) for an additional 4 weeks.

Treatment:

Drug: Allopurinol

Drug: Placebo