African American Study of Kidney Disease and Hypertension ABPM Pilot Study

• ClinicalTrials.gov Identifier: NCT00582777
• Recruitment Status: Completed
• First Posted: December 28, 2007
• Last Update Posted: April 16, 2012
• Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Information provided by: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Hypertensive Renal Disease	Behavioral: USUAL - take your BP Meds as you usually do; Behavioral: HS DOSING; Drug: ADD On Dosing	Phase 2; Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 180 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: African American Study of Kidney Disease and Hypertension ABPM Pilot Study
• Study Start Date: November 2007
• Actual Primary Completion Date: December 2008
• Actual Study Completion Date: December 2008

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: USUAL; 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.	Behavioral: USUAL - take your BP Meds as you usually do; 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.
Experimental: HS Dosing; 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.; For those on monotherapy with a once/day antihypertensive regimen, the time of administration will be changed to bed time.; For those on multi-drug therapy, the time of administration of all once a day antihypertensive drugs will be changed to bed time.	Behavioral: HS DOSING; Take your usual BP meds at bed time
Experimental: ADD-ON DOSING; 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.	Drug: ADD On Dosing; Take your usual BP meds but add one more med at bed time.

Outcome Measures

Primary Outcome Measures :

1. Night Time Blood Pressure [ Time Frame: Night time blood pressure from APBM at weeks 6, 12, and 18 ]

Secondary Outcome Measures :

1. Blood pressure in the clinic Daytime blood pressure [ Time Frame: Measured at weeks 6, 12, and 18 ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, Alabama

University of Alabama

Birmingham, Alabama, United States, 35233

United States, California

University of Southern California

Los Angeles, California, United States, 90033

Charles Drew Medical College

Los Angeles, California, United States, 90059

University of California at San Diego

San Diego, California, United States, 92161

United States, Florida

University of Florida

Gainesville, Florida, United States, 32611

University of Miami

Miami, Florida, United States, 33101

United States, Georgia

Emory University

Atlanta, Georgia, United States, 30308

United States, Illinois

University of Chicago

Chicago, Illinois, United States, 60637

United States, Maryland

Johns Hopkins University

Baltimore, Maryland, United States, 21205

United States, Michigan

University of Michigan

Ann Arbor, Michigan, United States, 48106

United States, New York

Lenox Hill Hospital

New York, New York, United States, 10021

United States, Ohio

University Hospitals of Cleveland

Cleveland, Ohio, United States, 44106

Ohio State University

Columbus, Ohio, United States, 43210

United States, South Carolina

Medical University of South Carolina

Charleston, South Carolina, United States, 29425

United States, Tennessee

Vanderbilt University

Nashville, Tennessee, United States, 37232

United States, Texas

Univesity of Texas Southwestern Medical Center at Dallas

Dallas, Texas, United States, 75390

Sponsors and Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Investigators

• Study Chair: Mahboob Rahman, M.D.; University Hospitals, Cleveland
• Principal Investigator: 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: 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

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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.

• Responsible Party: Lawrence Agodoa, M.D., NIDDK
• ClinicalTrials.gov Identifier: NCT00582777
• Other Study ID Numbers: AASK ABPM Pilot (completed); 7 U01 KD04868
• First Posted: December 28, 2007
• Last Update Posted: April 16, 2012
• Last Verified: April 2012

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

nocturnal blood pressure; chronic renal disease; hypertensive renal disease; African Americans; ABPM

Additional relevant MeSH terms:

Kidney Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases; Urologic Diseases