Phase 3 N=99 Randomized Double-blind Treatment

Center of Research Translation (CORT) Project 2

Pre-hypertension · JNC 7 Stage I Hypertension

Bottom Line

View on ClinicalTrials.gov: NCT02038179 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Feb 2020

Primary outcome: Primary: Change in Systolic Blood Pressure (SBP) — -1.39; -1.06 mm Hg — p=0.83

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Allopurinol (Drug); Placebo (Drug)
Age: Adult · 18+ yrs
Sex: All
Sponsor: University of Alabama at Birmingham
Primary completion: Aug 2018

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Systolic Blood Pressure (SBP)	-1.39; -1.06	0.83
PRIMARY Change in Flow-mediated Arterial Vasodilation	2.5; -0.1	<0.001 sig
PRIMARY Change in Serum Levels of High Sensitivity C-reactive Protein	0.6; 0.8	0.84

Summary

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02038179). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.