Skip to main content
OpenTrials
Completed

NCT Number: NCT02038179

Center of Research Translation (CORT) Project 2

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Pre-Hypertension Cardiovascular Diseases JNC 7 Stage I Hypertension Prehypertension Vascular Diseases

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Allopurinol

Drug

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

Drug

Participants who received placebo tablet (matching Allopurinol 300 mg) daily by mouth for a 4 week duration.

Primary outcomes

  1. Change in Systolic Blood Pressure (SBP)

    Time frame: 4 weeks (pre-treatment vs. post-treatment 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.

  2. Change in Flow-mediated Arterial Vasodilation

    Time frame: 4 weeks (pre-treatment vs. post-treatment FMD Values (%))

    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.

  3. Change in Serum Levels of High Sensitivity C-reactive Protein

    Time frame: 4 weeks (pre-treatment vs. post-treatment serum levels)

    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.

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Collaborators

  • National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Jan 16, 2014
Registry last updated
Jan 11, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.