24 Hour Blood Pressure, Gout, Hypertension, Prehypertension, Pulse Wave Velocity
Conditions
Keywords
Prehypertension, Gout, Puls Wave Velocity, Hypertension, 24 hour blood pressure
Brief summary
High normal blood pressure, also called prehypertension, is a significant problem. High uric acid in the blood, the same thing that causes gout, may cause higher blood pressures. The investigators plan to monitor the effects of the drug febuxostat(trade name Uloric) on blood pressure and stiffness of the main blood vessels and see if lowering uric acid has any effect.
Interventions
DRUGFebuxostat
80mg PO daily for 8 weeks
Sponsors
University of California, San Diego
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* Prehypertensive male and female subjects with SBP =120-140 mmHg or DBP =80-90 mmHg (as determined by seated office BP). * Plasma uric acid level ≥5 mg/dl * Ages 18-50 * non-smokers * Subjects will need to remain in the San Diego area for the duration of the study and be accessible by telephone or email.
Exclusion criteria
* no current smoking in the prior 6 months. * Any history of any serious medical conditions requiring close monitoring from physicians- such as liver impairment, chronic kidney disease, or diabetes mellitus. Participants not currently under the care of a physician for these conditions will be eligible for the study. * Any history of gout, hypertension, hypercholesterolemia, morbid obesity. * Any history of use xanthine oxidase inhibitors, antihypertensives, antiglycemic, and cholesterol lowering medications * any history of illicit drug use within the last 6 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in 24 Hour Blood Pressure | 8 weeks |
| Changes in Pulse Wave Velocity | 8 weeks |
Countries
United States
Participant flow
Pre-assignment details
The Principal Investigator for this study has passed away and the results data is not available.
Participants by arm
| Arm | Count |
|---|---|
| Febuxostat Febuxostat: 80mg PO daily for 8 weeks | 0 |
| Placebo Febuxostat: 80mg PO daily for 8 weeks | 0 |
| Total | 0 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Changes in 24 Hour Blood Pressure
Time frame: 8 weeks
Population: The Principal Investigator for this study has passed away and the results data is not available.
Primary
Changes in Pulse Wave Velocity
Time frame: 8 weeks
Population: The Principal Investigator for this study has passed away and the results data is not available.