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| ID | Type | Description | Link |
|---|---|---|---|
| 7 U01 KD04868 |
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4. Methods 4a. Overview The study will be conducted in participants in the African-American Study of Kidney Disease (AASK) Cohort study as a randomized three period cross-over trial.
Eighty five percent of AASK cohort participants are currently on an ACE inhibitor or angiotensin receptor blocker; the most commonly used ACE inhibitor is ramipril. The new strategies proposed in this pilot study will remain ramipril-based, to maintain the overall blood pressure control achieved thus far.
The antihypertensive regimens proposed are as follows:
The "usual arm" serves as the comparator arm. The "hs dosing" and "add-on dosing" arms test practical strategies that could be tested in a subsequent clinical outcomes trial and that could be implemented in clinical practice. We hypothesize that both arms will reduce nocturnal BP in comparison to "usual dosing". We further hypothesize that the "hs dosing" arm will raise daytime BP somewhat but have no net effect on 24 hour BP and that the "add on dosing" arm will have no effect on daytime BP but lower 24 hour BP.
This pilot study will begin after the last scheduled AASK Cohort study visit. Eligible participants will be treated for 6 weeks on each of 3 antihypertensive regimens. The sequence of the regimens will be random. Each period of the three periods will have 2 visits, one visit at 3 weeks and one visit at 6 weeks. In the last week of each 6-week period, a 24-hour ABPM will be obtained. The primary outcome variable is nocturnal BP; each pair wise difference between the regimens will be calculated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| USUAL | Active Comparator | USUAL treatment - The patient's antihypertensive regimen at the baseline visit is the comparison (or control) regimen. All once a day medications will be administered in the morning. |
|
| HS Dosing | Experimental | HS DOSING - In this period, the patient's antihypertensive regimen at the baseline visit will be standardized for the once/day medications to be given at bedtime.
|
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| ADD-ON DOSING | Experimental | ADD-ON DOSING - This regimen will start with the USUAL regimen to which an additional agent will be added at bed time. An additional dose of ramipril, diltiazem, or hydralazine are three possible options for the add on medication. The intent of the ADD ON therapy is to lower nocturnal BP with minimal impact on daytime BP. Thus, agents with < 24 hr duration of action are preferred. The specific choice and dose of add-on therapy (of the three agents) will be up to the site investigator considering the clinical situation of each participant based on the guidelines below. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| USUAL - take your BP Meds as you usually do | Behavioral | The patient's antihypertensive regimen at the baseline visit is the comparison (or control) regimen. All once a day medications will be administered in the morning. |
| Measure | Description | Time Frame |
|---|---|---|
| Night Time Blood Pressure | Night time blood pressure from APBM at weeks 6, 12, and 18 |
| Measure | Description | Time Frame |
|---|---|---|
| Blood pressure in the clinic Daytime blood pressure | Measured at weeks 6, 12, and 18 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mahboob Rahman, M.D. | University Hospitals, Cleveland | Study Chair |
| Jackson T. Wright, Jr., MD, Ph.D., FACP | University Hospitals Cleveland Medical Center | Principal Investigator |
| Janice Lea, MD | Emory Center for Hypertension and Renal Disease Research | Principal Investigator |
| Francis B. Gabbai, MD | University of Calirfornia, San Diego | Principal Investigator |
| Otelio S. Randall, MD | Howard University | Principal Investigator |
| Lawrence Appel, MD, MPH | Johns Hopkins University | Principal Investigator |
| Keith Norris, MD | Charles Drew Medical Center | Principal Investigator |
| DeAnna Cheek, MD | Medical University of South Carolina | Principal Investigator |
| Michael Lipkowitz, MD | Lenox Hill Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama | Birmingham | Alabama | 35233 | United States | ||
| University of Southern California |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28830083 | Derived | Juraschek SP, Appel LJ, Miller ER 3rd. Metoprolol Increases Uric Acid and Risk of Gout in African Americans With Chronic Kidney Disease Attributed to Hypertension. Am J Hypertens. 2017 Sep 1;30(9):871-875. doi: 10.1093/ajh/hpx113. | |
| 23172931 | Derived | Rahman M, Greene T, Phillips RA, Agodoa LY, Bakris GL, Charleston J, Contreras G, Gabbai F, Hiremath L, Jamerson K, Kendrick C, Kusek JW, Lash JP, Lea J, Miller ER 3rd, Rostand S, Toto R, Wang X, Wright JT Jr, Appel LJ. A trial of 2 strategies to reduce nocturnal blood pressure in blacks with chronic kidney disease. Hypertension. 2013 Jan;61(1):82-8. doi: 10.1161/HYPERTENSIONAHA.112.200477. Epub 2012 Nov 19. |
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| HS DOSING | Behavioral | Take your usual BP meds at bed time |
|
| ADD On Dosing | Drug | Take your usual BP meds but add one more med at bed time. |
|
| Lee Hebert, MD | Ohio State University | Principal Investigator |
| George Bakris, MD | University of Chicago | Principal Investigator |
| Stephen G. Rostand, MD | University of Alabama at Birmingham | Principal Investigator |
| Geraldine Bichier, MD | University of Florida | Principal Investigator |
| Gabriel Contreras, MD | University of Miami | Principal Investigator |
| Kenneth Jamerson, MD | University of Michigan | Principal Investigator |
| Miroslav J. Smogorzewski, MD | University of Southern California | Principal Investigator |
| Robert D. Toto, MD | University of Texas, Southwestern Medical Center at Dallas | Principal Investigator |
| Julia A. Lewis, MD | Vanderbilt University | Principal Investigator |
| Los Angeles |
| California |
| 90033 |
| United States |
| Charles Drew Medical College | Los Angeles | California | 90059 | United States |
| University of California at San Diego | San Diego | California | 92161 | United States |
| University of Florida | Gainesville | Florida | 32611 | United States |
| University of Miami | Miami | Florida | 33101 | United States |
| Emory University | Atlanta | Georgia | 30308 | United States |
| University of Chicago | Chicago | Illinois | 60637 | United States |
| Johns Hopkins University | Baltimore | Maryland | 21205 | United States |
| University of Michigan | Ann Arbor | Michigan | 48106 | United States |
| Lenox Hill Hospital | New York | New York | 10021 | United States |
| University Hospitals of Cleveland | Cleveland | Ohio | 44106 | United States |
| Ohio State University | Columbus | Ohio | 43210 | United States |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| Vanderbilt University | Nashville | Tennessee | 37232 | United States |
| Univesity of Texas Southwestern Medical Center at Dallas | Dallas | Texas | 75390 | United States |
| ID | Term |
|---|---|
| C563161 | Hypertensive Nephropathy |
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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