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Center of Research Translation (CORT) Project 2

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02038179
Recruitment Status : Completed
First Posted : January 16, 2014
Results First Posted : February 26, 2020
Last Update Posted : March 17, 2020
Sponsor:
Collaborator:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Information provided by (Responsible Party):
Kenneth Saag, MD, MSc, University of Alabama at Birmingham

Tracking Information
First Submitted Date  ICMJE December 20, 2013
First Posted Date  ICMJE January 16, 2014
Results First Submitted Date  ICMJE November 27, 2019
Results First Posted Date  ICMJE February 26, 2020
Last Update Posted Date March 17, 2020
Study Start Date  ICMJE July 2014
Actual Primary Completion Date August 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 12, 2020)
  • 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.
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: January 14, 2014)
  • Serum urate level [ Time Frame: Baseline to Visit 5 (14 weeks) ]
    Serum urate level is measured and compared to previous measures.
  • Serum urate level [ Time Frame: Baseline to Visit 3 (6 weeks) ]
    Serum urate level is measured and will be compared to baseline
  • Serum urate level [ Time Frame: Baseline to Visit 4 (10 weeks) ]
    Serum urate level is measured and will be compared to baseline.
  • Serum urate level [ Time Frame: Baseline (Visit 1) ]
    Baseline serum urate level is measured.
  • Serum urate level [ Time Frame: Baseline toVisit 2 (2 weeks) ]
    Serum urate level is measured and compared to baseline
  • Endothelial function as measured by flow mediated dilation (FMD) [ Time Frame: Baseline (Visit 2) to Visit 5 (12 weeks) ]
    Endothelial function is measured and compared to previous measures.
  • Endothelial function as measured by flow mediated dilation (FMD) [ Time Frame: Baseline (Visit 2) to Visit 4 (8 weeks) ]
    Endothelial function is measured and compared to previous measures.
  • Endothelial function as measured by flow mediated dilation (FMD) [ Time Frame: Baseline (Visit 2) to Visit 3 (4 weeks) ]
    Endothelial function is measured and compared to previous measures.
  • Endothelial function as measured by flow mediated dilation (FMD) [ Time Frame: Visit 2 (baseline) ]
    Endothelial function is measured and baseline is established.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Center of Research Translation (CORT) Project 2
Official Title  ICMJE University of Alabama at Birmingham CORT Project 2: The Effects of Urate Lowing Therapy (ULT) in Inflammation, Endothelial Function, and Blood Pressure
Brief 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Pre-hypertension
  • JNC 7 Stage I Hypertension
Intervention  ICMJE
  • 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.
  • Drug: Placebo
    Participants who received placebo tablet (matching Allopurinol 300 mg) daily by mouth for a 4 week duration.
Study Arms  ICMJE
  • Experimental: Allopurinol, Then Placebo
    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.
    Interventions:
    • Drug: Allopurinol
    • Drug: Placebo
  • Experimental: Placebo, Then Allopurinol
    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.
    Interventions:
    • Drug: Allopurinol
    • Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 25, 2018)
99
Original Estimated Enrollment  ICMJE
 (submitted: January 14, 2014)
112
Actual Study Completion Date  ICMJE August 2018
Actual Primary Completion Date August 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02038179
Other Study ID Numbers  ICMJE F130408004
P50AR060772 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Kenneth Saag, MD, MSc, University of Alabama at Birmingham
Study Sponsor  ICMJE University of Alabama at Birmingham
Collaborators  ICMJE National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Investigators  ICMJE Not Provided
PRS Account University of Alabama at Birmingham
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP