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UAB Center of Research Translation (CORT) Project 2: The Effects of Urate Lowing Therapy (ULT) in Inflammation, Endothelial Function, and Blood Pressure

This study is currently recruiting participants.
Verified September 2017 by Kenneth Saag, MD, MSc, University of Alabama at Birmingham
Sponsor:
ClinicalTrials.gov Identifier:
NCT02038179
First Posted: January 16, 2014
Last Update Posted: October 2, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
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
  Purpose
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 Intervention Phase
Pre-hypertension JNC 7 Stage I Hypertension Drug: Allopurinol Drug: Placebo Phase 2 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: UAB Center of Research Translation (CORT) Project 2: The Effects of Urate Lowing Therapy (ULT) in Inflammation, Endothelial Function, and Blood Pressure

Resource links provided by NLM:


Further study details as provided by Kenneth Saag, MD, MSc, University of Alabama at Birmingham:

Primary Outcome Measures:
  • 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 to Visit 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.


Estimated Enrollment: 112
Study Start Date: July 2014
Estimated Study Completion Date: August 2018
Estimated Primary Completion Date: August 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Allopurinol arm
Participants will be asked to take 4 weeks of allopurinol or placebo, then will crossover to the other drug (after 4 week washout period) and take either allopurinol or placebo for an additional 4 weeks.
Drug: Allopurinol
The subjects will be randomized to receive allopurinol as ULT, at a daily dose of 300 mg once daily by mouth or placebo. Participants will be asked to take 4 weeks of allopurinol or placebo, then will crossover to the other drug (after 4 week washout period) and take either allopurinol or placebo for an additional 4 weeks.
Placebo Comparator: Placebo Arm
Participants will be asked to take 4 weeks of allopurinol or placebo, then will crossover to the other drug (after 4 week washout period) and take either allopurinol or placebo for an additional 4 weeks.
Drug: Placebo
The subjects will be randomized to receive allopurinol as ULT, at a daily dose of 300 mg once daily by mouth or placebo. Participants will be asked to take 4 weeks of allopurinol or placebo, then will crossover to the other drug (after 4 week washout period) and take either allopurinol or placebo for an additional 4 weeks.

  Eligibility

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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
  • 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
  Contacts and Locations
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
United States, Alabama
University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35294
Contact: Jeff Foster, MPH    205-996-6086    pjfoster@uabmc.edu   
Principal Investigator: Kenneth G Saag, MD, MsC         
Sponsors and Collaborators
University of Alabama at Birmingham
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
  More Information

Responsible Party: Kenneth Saag, MD, MSc, Professor of Medicine, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT02038179     History of Changes
Other Study ID Numbers: F130408004
P50AR060772 ( U.S. NIH Grant/Contract )
First Submitted: December 20, 2013
First Posted: January 16, 2014
Last Update Posted: October 2, 2017
Last Verified: September 2017

Keywords provided by Kenneth Saag, MD, MSc, University of Alabama at Birmingham:
Pre-hypertension
JNC 7 stage I hypertension

Additional relevant MeSH terms:
Prehypertension
Hypertension
Inflammation
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Allopurinol
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Gout Suppressants
Antirheumatic Agents
Free Radical Scavengers
Antioxidants
Protective Agents
Physiological Effects of Drugs