Clinical trial NCT00582777: African American Study of Kidney Disease and Hypertension ABPM Pilot Study
Official title: African American Study of Kidney Disease and Hypertension ABPM Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Hypertensive Renal Disease
Keywords: nocturnal blood pressure
chronic renal disease
hypertensive renal disease
African Americans
ABPM
Lead sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Sponsor class: NIH
First posted: 2007-12-28
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Night Time Blood Pressure
timeFrame: Night time blood pressure from APBM at weeks 6, 12, and 18
Secondary outcomes:
measure: Blood pressure in the clinic Daytime blood pressure
timeFrame: Measured at weeks 6, 12, and 18
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama
state: Alabama
city: Los Angeles
country: United States
facility: University of Southern California
state: California
city: Los Angeles
country: United States
facility: Charles Drew Medical College
state: California
city: San Diego
country: United States
facility: University of California at San Diego
state: California
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Miami
country: United States
facility: University of Miami
state: Florida
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: New York
country: United States
facility: Lenox Hill Hospital
state: New York
city: Cleveland
country: United States
facility: University Hospitals of Cleveland
state: Ohio
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Nashville
country: United States
facility: Vanderbilt University
state: Tennessee
city: Dallas
country: United States
facility: Univesity of Texas Southwestern Medical Center at Dallas
state: Texas
Study officials:
affiliation: University Hospitals, Cleveland
name: Mahboob Rahman, M.D.
role: STUDY_CHAIR
affiliation: University Hospitals Cleveland Medical Center
name: Jackson T. Wright, Jr., MD, Ph.D., FACP
role: PRINCIPAL_INVESTIGATOR
affiliation: Emory Center for Hypertension and Renal Disease Research
name: Janice Lea, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Calirfornia, San Diego
name: Francis B. Gabbai, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Howard University
name: Otelio S. Randall, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Johns Hopkins University
name: Lawrence Appel, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Charles Drew Medical Center
name: Keith Norris, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Medical University of South Carolina
name: DeAnna Cheek, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Lenox Hill Hospital
name: Michael Lipkowitz, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ohio State University
name: Lee Hebert, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Chicago
name: George Bakris, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Alabama at Birmingham
name: Stephen G. Rostand, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Florida
name: Geraldine Bichier, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Miami
name: Gabriel Contreras, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Michigan
name: Kenneth Jamerson, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Southern California
name: Miroslav J. Smogorzewski, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Texas, Southwestern Medical Center at Dallas
name: Robert D. Toto, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Vanderbilt University
name: Julia A. Lewis, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.