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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

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.

Condition or disease Intervention/treatment Phase
Pre-hypertension JNC 7 Stage I Hypertension Drug: Allopurinol Drug: Placebo Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 99 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: University of Alabama at Birmingham CORT Project 2: The Effects of Urate Lowing Therapy (ULT) in Inflammation, Endothelial Function, and Blood Pressure
Study Start Date : July 2014
Actual Primary Completion Date : August 2018
Actual Study Completion Date : August 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
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.

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.
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.




Primary Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02038179


Locations
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United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
Sponsors and Collaborators
University of Alabama at Birmingham
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
  Study Documents (Full-Text)

Documents provided by Kenneth Saag, MD, MSc, University of Alabama at Birmingham:
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Responsible Party: Kenneth Saag, MD, MSc, Professor of Medicine, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT02038179    
Other Study ID Numbers: F130408004
P50AR060772 ( U.S. NIH Grant/Contract )
First Posted: January 16, 2014    Key Record Dates
Results First Posted: February 26, 2020
Last Update Posted: March 17, 2020
Last Verified: March 2020
Keywords provided by Kenneth Saag, MD, MSc, University of Alabama at Birmingham:
Pre-hypertension
JNC 7 stage I hypertension
Additional relevant MeSH terms:
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Hypertension
Prehypertension
Vascular Diseases
Cardiovascular Diseases
Allopurinol
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Gout Suppressants
Antirheumatic Agents
Free Radical Scavengers
Antioxidants
Protective Agents
Physiological Effects of Drugs