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unable to enroll participants
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Hyperuricemia (high uric acid level) has been correlated to hypertension (high blood pressure) and overall cardiovascular disease risk in several studies. The relationship has even been noted to be independent of metabolic syndrome and kidney function. It has been repeatedly noted that hyperuricemia was an independent risk factor of death in those at high cardiovascular disease risk. A recent review concluded that there is strong evidence that hyperuricemia and gout are coupled with atherosclerosis and cardiovascular events.
Although this correlation of hypertension and hyperuricemia is known, there has only been one published study that has evaluated if lowering the uric acid would reduce the blood pressure. The authors concluded that in newly diagnosed hypertensive adolescents, allopurinol decreased the blood pressure. Despite this, further evaluation of this therapeutic approach has not been studied.
The hypothesis of this study is that febuxostat, a new xanthine oxidase inhibitor, has blood pressure lowering effects superior to allopurinol in patients diagnosed with gout.
Screening and Recruitment
Provide Consent
Data collection
After consent is provided, study personnel will evaluate blood pressure (BP).
Participants will undergo 24-hour Ambulatory Blood Pressure Monitor (ABPM). The normal fee for ABPM will be waived.
Participants will then discontinue allopurinol and initiate febuxostat at a comparable dose. Febuxostat will be provided to all participants at no cost.
After at least 4 weeks of febuxostat, the participant will repeat 24-hour ABPM. The normal fee for ABPM will be waived.
After completion of the febuxostat portion of the study, participants will receive a compensation of $50 at the end of the study. Compensation will only be provided to those who complete the entire study.
Results
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Allopurinol, febuxostat | Experimental | Patients currently treated with allopurinol will be switched to febuxostat, and the blood pressure differences between the two arms will be compared. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| febuxostat | Drug | If baseline allopurinol dose < 300 mg daily, will initiate febuxostat 40 mg daily. If baseline allopurinol dose > 300 mg daily, will initiate febuxostat 80 mg daily. Febuxostat is to be continued for 4 weeks, with blood pressure assessments by clinic and ambulatory blood pressure measurement at baseline and after 4 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| BP Differences While on Allopurinol and Febuxostat by Clinic Blood Pressure Readings and 24-hour Ambulatory Blood Pressure Readings | The data collected will be analyzed and categorized according to age, race, gender, weight, height, 24-hour ABPM (24-hour systolic blood pressure (SBP)/diastolic blood pressure (DBP), trough SBP/DBP, and the mean nighttime SBP/SBP). Clinic systolic and diastolic BP and 24-hour AMBPs will be compared between the two treatments. | 4 to 5 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| If Patients With Hypertension Receive a Greater Reduction in Blood Pressure (BP) While on Febuxostat (Versus Allopurinol) | measured by mean 24-hour systolic blood pressure (SBP)/diastolic blood pressure (DBP), trough SBP/DBP, and mean nighttime SBP/SBP while on allopurionol and febuxostat. | Participants will be followed for an expected average of 4 to 5 weeks. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Amber S Holdiness, PharmD | University of Mississippi Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Mississippi Medical Center General Medicine/Hypertension and Family Medicine Clinics | Jackson | Mississippi | 39216 | United States |
No significant events or approaches to report.
Recruitment - January 2010 - October 2011 Medical clinic
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| ID | Title | Description |
|---|---|---|
| FG000 | Allopurinol, Febuxostat | Patients currently treated with allopurinol will be switched to febuxostat, and the blood pressure differences between the two arms will be compared. febuxostat : If baseline allopurinol dose < 300 mg daily, will initiate febuxostat 40 mg daily. If baseline allopurinol dose > 300 mg daily, will initiate febuxostat 80 mg daily. Febuxostat is to be continued for 4 weeks, with blood pressure assessments by clinic and ambulatory blood pressure measurement at baseline and after 4 weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Allopurinol, Febuxostat | Patients currently treated with allopurinol will be switched to febuxostat, and the blood pressure differences between the two arms will be compared. febuxostat : If baseline allopurinol dose < 300 mg daily, will initiate febuxostat 40 mg daily. If baseline allopurinol dose > 300 mg daily, will initiate febuxostat 80 mg daily. Febuxostat is to be continued for 4 weeks, with blood pressure assessments by clinic and ambulatory blood pressure measurement at baseline and after 4 weeks. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | BP Differences While on Allopurinol and Febuxostat by Clinic Blood Pressure Readings and 24-hour Ambulatory Blood Pressure Readings | The data collected will be analyzed and categorized according to age, race, gender, weight, height, 24-hour ABPM (24-hour systolic blood pressure (SBP)/diastolic blood pressure (DBP), trough SBP/DBP, and the mean nighttime SBP/SBP). Clinic systolic and diastolic BP and 24-hour AMBPs will be compared between the two treatments. | no analysis, as only one participant | Posted | 4 to 5 weeks |
|
adverse event data collected over a total period of 4 weeks
Spontaneously report adverse events
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Febuxostat | Febuxostat group. The primary outcome of the study is the 24 hour ABPM differences while participants were taking allopurinol compared to taking febuxostat. |
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Early termination leading to no subjects analyzed
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Debbie Minor | University of Mississippi Medical Center | 601-984-6888 | DMinor@umc.edu |
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| ID | Term |
|---|---|
| D006073 | Gout |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D000070657 | Crystal Arthropathies |
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| ID | Term |
|---|---|
| D000069465 | Febuxostat |
| ID | Term |
|---|---|
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
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|
|
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Blood pressure | Mean | Standard Deviation | mm Hg |
|
|
| Secondary | If Patients With Hypertension Receive a Greater Reduction in Blood Pressure (BP) While on Febuxostat (Versus Allopurinol) | measured by mean 24-hour systolic blood pressure (SBP)/diastolic blood pressure (DBP), trough SBP/DBP, and mean nighttime SBP/SBP while on allopurionol and febuxostat. | Posted | Participants will be followed for an expected average of 4 to 5 weeks. |
|
|
| 0 |
| 1 |
| 0 |
| 1 |
| 0 |
| 1 |
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| D012216 |
| Rheumatic Diseases |
| D011686 | Purine-Pyrimidine Metabolism, Inborn Errors |
| D008661 | Metabolism, Inborn Errors |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |