African American Study of Kidney Disease and Hypertension ABPM Pilot Study

Condition(s) targeted: Hypertensive Renal Disease

Intervention: USUAL - take your BP Meds as you usually do (Behavioral); HS DOSING (Behavioral); ADD On Dosing (Drug)

Phase: Phase 2/Phase 3

Status: Completed

Sponsored by: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Official(s) and/or principal investigator(s):
Mahboob Rahman, M.D., Study Chair, Affiliation: University Hospitals, Cleveland
Jackson T. Wright, Jr., MD, Ph.D., FACP, Principal Investigator, Affiliation: University Hospital Case Medical Center
Janice Lea, MD, Principal Investigator, Affiliation: Emory Center for Hypertension and Renal Disease Research
Francis B. Gabbai, MD, Principal Investigator, Affiliation: University of Calirfornia, San Diego
Otelio S. Randall, MD, Principal Investigator, Affiliation: Howard University
Lawrence Appel, MD, MPH, Principal Investigator, Affiliation: Johns Hopkins University
Keith Norris, MD, Principal Investigator, Affiliation: Charles Drew Medical Center
DeAnna Cheek, MD, Principal Investigator, Affiliation: Medical University of South Carolina
Michael Lipkowitz, MD, Principal Investigator, Affiliation: Lenox Hill Hospital
Lee Hebert, MD, Principal Investigator, Affiliation: Ohio State University
George Bakris, MD, Principal Investigator, Affiliation: University of Chicago
Stephen G. Rostand, MD, Principal Investigator, Affiliation: University of Alabama at Birmingham
Geraldine Bichier, MD, Principal Investigator, Affiliation: University of Florida
Gabriel Contreras, MD, Principal Investigator, Affiliation: University of Miami
Kenneth Jamerson, MD, Principal Investigator, Affiliation: University of Michigan
Miroslav J. Smogorzewski, MD, Principal Investigator, Affiliation: University of Southern California
Robert D. Toto, MD, Principal Investigator, Affiliation: University of Texas Southwestern Medical Center at Dallas
Julia A. Lewis, MD, Principal Investigator, Affiliation: Vanderbilt University

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.

Official title: African American Study of Kidney Disease and Hypertension ABPM Pilot Study

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Night Time Blood Pressure

Secondary outcome: Blood pressure in the clinic Daytime blood pressure

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

University of Alabama, Birmingham, Alabama 35233, United States

Charles Drew Medical College, Los Angeles, California 90059, United States

University of Southern California, Los Angeles, California 90033, 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

Starting date: November 2007
Last updated: April 12, 2012