African American Study of Kidney Disease and Hypertension ABPM Pilot Study

NCT ID: NCT00582777

Last Updated: 2012-04-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 180 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-11-30
• Study Completion Date: 2008-12-31

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.

Conditions

Hypertensive Renal Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

USUAL - take your BP Meds as you usually do

Intervention Type: 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.

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.

Group Type: EXPERIMENTAL

HS DOSING

Intervention Type: BEHAVIORAL

Take your usual BP meds at bed time

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.

Group Type: EXPERIMENTAL

ADD On Dosing

Intervention Type: DRUG

Take your usual BP meds but add one more med at bed time.

Interventions

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.

Intervention Type: BEHAVIORAL

HS DOSING

Take your usual BP meds at bed time

Intervention Type: BEHAVIORAL

ADD On Dosing

Take your usual BP meds but add one more med at bed time.

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

NIH

Sponsor Role: lead

Responsible Party

NIDDK

Principal Investigators

Mahboob Rahman, M.D.

Role: STUDY_CHAIR

University Hospitals, Cleveland

Jackson T. Wright, Jr., MD, Ph.D., FACP

Role: PRINCIPAL_INVESTIGATOR

University Hospitals Cleveland Medical Center

Janice Lea, MD

Role: PRINCIPAL_INVESTIGATOR

Emory Center for Hypertension and Renal Disease Research

Francis B. Gabbai, MD

Role: PRINCIPAL_INVESTIGATOR

University of Calirfornia, San Diego

Otelio S. Randall, MD

Role: PRINCIPAL_INVESTIGATOR

Howard University

Lawrence Appel, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Keith Norris, MD

Role: PRINCIPAL_INVESTIGATOR

Charles Drew Medical Center

DeAnna Cheek, MD

Role: PRINCIPAL_INVESTIGATOR

Medical University of South Carolina

Michael Lipkowitz, MD

Role: PRINCIPAL_INVESTIGATOR

Lenox Hill Hospital

Lee Hebert, MD

Role: PRINCIPAL_INVESTIGATOR

Ohio State University

George Bakris, MD

Role: PRINCIPAL_INVESTIGATOR

University of Chicago

Stephen G. Rostand, MD

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Geraldine Bichier, MD

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Gabriel Contreras, MD

Role: PRINCIPAL_INVESTIGATOR

University of Miami

Kenneth Jamerson, MD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Miroslav J. Smogorzewski, MD

Role: PRINCIPAL_INVESTIGATOR

University of Southern California

Robert D. Toto, MD

Role: PRINCIPAL_INVESTIGATOR

University of Texas, Southwestern Medical Center at Dallas

Julia A. Lewis, MD

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University

Locations

University of Alabama

Birmingham, Alabama, United States

University of Southern California

Los Angeles, California, United States

Charles Drew Medical College

Los Angeles, California, United States

University of California at San Diego

San Diego, California, United States

University of Florida

Gainesville, Florida, United States

University of Miami

Miami, Florida, United States

Emory University

Atlanta, Georgia, United States

University of Chicago

Chicago, Illinois, United States

Johns Hopkins University

Baltimore, Maryland, United States

University of Michigan

Ann Arbor, Michigan, United States

Lenox Hill Hospital

New York, New York, United States

University Hospitals of Cleveland

Cleveland, Ohio, United States

Ohio State University

Columbus, Ohio, United States

Medical University of South Carolina

Charleston, South Carolina, United States

Vanderbilt University

Nashville, Tennessee, United States

Univesity of Texas Southwestern Medical Center at Dallas

Dallas, Texas, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 28830083 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 23172931 (View on PubMed)

Other Identifiers

7 U01 KD04868

Identifier Type: -

Identifier Source: secondary_id

AASK ABPM Pilot (completed)

Identifier Type: -

Identifier Source: org_study_id