Hypertensive Renal Disease Clinical Trial
Official title:
African American Study of Kidney Disease and Hypertension ABPM Pilot Study
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:
- AM dosing of ramipril and other once daily medications in the participants
antihypertensive regimen (termed USUAL),
- Bedtime dosing of ramipril and other once a day medications in the participant's
antihypertensive regimen (termed HS-DOSING), and
- their current antihypertensive regimen plus an additional antihypertensive agent dosed
at bed time; the choice of the additional agent will be tailored based on prespecified
clinical guidelines (termed ADD-ON DOSING)
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.
| Status | Completed |
| Enrollment | 180 |
| Est. completion date | December 2008 |
| Est. primary completion date | December 2008 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Participant in the AASK Cohort Study - Ability and willingness to provide informed consent - Completion of a technically adequate ABPM at CO48 AASK cohort study visit. - Participants must have had at least 2 visits in the last 12 months of the Cohort Study (July 1 2006 to June 1 2007) - The average of last two BPs measured at least one week apart in the Cohort Study must be less than or equal to 140/90 mm Hg. This would exclude a small percentage of the AASK cohort population; however, it would enroll a group of participants with stable BP who should not require adjustments to their antihypertensive medications during the course of this study. - Antihypertensive medications at baseline visit: This refers to the participant's antihypertensive regimen at the time of the baseline visit ; the transition period may be used to adjust the participant's antihypertensive regimen to meet these criteria, based on the clinical judgement of the site investigator. Exclusion Criteria: - Arm circumference greater than 50 cms. - ESRD requiring renal replacement therapy or kidney transplantation - Institutionalized participants - Shift workers working at night - MI or CVA within 3 months of AASK Cohort close out visit - Participants with known ejection fraction less than 40% - Females known to be pregnant or lactating - Participants likely to reach end stage renal disease within the next six weeks, in the judgement of the site investigator |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | University of Michigan | Ann Arbor | Michigan |
| United States | Emory University | Atlanta | Georgia |
| United States | Johns Hopkins University | Baltimore | Maryland |
| United States | University of Alabama | Birmingham | Alabama |
| United States | Medical University of South Carolina | Charleston | South Carolina |
| United States | University of Chicago | Chicago | Illinois |
| United States | University Hospitals of Cleveland | Cleveland | Ohio |
| United States | Ohio State University | Columbus | Ohio |
| United States | Univesity of Texas Southwestern Medical Center at Dallas | Dallas | Texas |
| United States | University of Florida | Gainesville | Florida |
| United States | Charles Drew Medical College | Los Angeles | California |
| United States | University of Southern California | Los Angeles | California |
| United States | University of Miami | Miami | Florida |
| United States | Vanderbilt University | Nashville | Tennessee |
| United States | Lenox Hill Hospital | New York | New York |
| United States | University of California at San Diego | San Diego | California |
| Lead Sponsor | Collaborator |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Night Time Blood Pressure | Night time blood pressure from APBM at weeks 6, 12, and 18 | No | |
| Secondary | Blood pressure in the clinic Daytime blood pressure | Measured at weeks 6, 12, and 18 | No |