Phase 3
Completed N=99
Center of Research Translation (CORT) Project 2
Hypertension · JNC 7 Stage I Hypertension
Source: ClinicalTrials.gov NCT02038179 ↗
Enrolled (actual)
99
Serious AEs
0.0%
Results posted
Feb 2020
Primary outcomePrimary: Change in Systolic Blood Pressure (SBP) — -1.39; -1.06 mm Hg — p=0.83
◆ Published Evidence
Established
51citations · ~10 / year
Effect of Serum Urate Lowering With Allopurinol on Blood Pressure in Young Adults: A Randomized, Controlled, Crossover Trial.
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.
Linked Publications (2)
-
Effect of Serum Urate Lowering With Allopurinol on Blood Pressure in Young Adults: A Randomized, Controlled, Crossover Trial.
-
Variation in serum urate levels in the absence of gout and urate lowering therapy.
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 |
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
Data sourced from ClinicalTrials.gov (NCT02038179) and the linked publication. 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. Informational only — not medical advice.