Center of Research Translation (CORT) Project 2

Pre-hypertension Clinical Trial

Official title:

University of Alabama at Birmingham CORT Project 2: The Effects of Urate Lowing Therapy (ULT) in Inflammation, Endothelial Function, and Blood Pressure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02038179
• Other study ID #: F130408004
• Secondary ID: P50AR060772
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: July 2014
• Est. completion date: August 2018

Study information

• Verified date: January 2021
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 99
• Est. completion date: August 2018
• Est. primary completion date: August 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypertension
• JNC 7 Stage I Hypertension
• Pre-hypertension
• Prehypertension

Intervention

Drug:
• Allopurinol
Participants who received allopurinol as urate lowering therapy, at a daily dose of 300 mg once daily by mouth for a 4 week duration.
• Placebo
Participants who received placebo tablet (matching Allopurinol 300 mg) daily by mouth for a 4 week duration.

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama

Sponsors (2)

Lead Sponsor	Collaborator
University of Alabama at Birmingham	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Systolic Blood Pressure (SBP)	Compare systolic blood pressure (SBP) captured by wearing a 24 hour ambulatory blood pressure monitor during each phase of treatment (allopurinol 300 mg/day PO or placebo). Change in systolic blood pressure is calculated by comparing SBP at the end of each treatment phase to pre-treatment values.	4 weeks (pre-treatment vs. post-treatment SBP)
Primary	Change in Flow-mediated Arterial Vasodilation	Compare endothelial function as indexed by flow-mediated arterial vasodilation (FMD) within each phase of treatment (allopurinol 300 mg/day PO or placebo). Percent (%) change in FMD is calculated by comparing FMD (%) at the end of each treatment phase to pre-treatment values.	4 weeks (pre-treatment vs. post-treatment FMD Values (%))
Primary	Change in Serum Levels of High Sensitivity C-reactive Protein	Serum level of high sensitivity C-reactive protein will be reported as a change during treatment phase (allopurinol 300 mg/day PO or placebo). Change in serum level of C-reactive protein is calculated by comparing serum values at the end of each treatment phase to pre-treatment levels.	4 weeks (pre-treatment vs. post-treatment serum levels)