African American Study of Kidney Disease and Hypertension ABPM Pilot Study

This study has been completed.
Sponsor:
Information provided by:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:
NCT00582777
First received: December 20, 2007
Last updated: April 12, 2012
Last verified: April 2012
  Purpose

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 Intervention 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 Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: African American Study of Kidney Disease and Hypertension ABPM Pilot Study

Resource links provided by NLM:


Further study details as provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

Primary Outcome Measures:
  • Night Time Blood Pressure [ Time Frame: Night time blood pressure from APBM at weeks 6, 12, and 18 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Blood pressure in the clinic Daytime blood pressure [ Time Frame: Measured at weeks 6, 12, and 18 ] [ Designated as safety issue: No ]

Estimated Enrollment: 180
Study Start Date: November 2007
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00582777

Locations
United States, Alabama
University of Alabama
Birmingham, Alabama, United States, 35233
United States, California
Charles Drew Medical College
Los Angeles, California, United States, 90059
University of Southern California
Los Angeles, California, United States, 90033
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
Investigators
Study Chair: Mahboob Rahman, M.D. University Hospitals, Cleveland
Principal Investigator: Jackson T. Wright, Jr., MD, Ph.D., FACP University Hospitals of Cleveland
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

No publications provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Lawrence Agodoa, M.D., NIDDK
ClinicalTrials.gov Identifier: NCT00582777     History of Changes
Other Study ID Numbers: AASK ABPM Pilot (completed), 7 U01 KD04868
Study First Received: December 20, 2007
Last Updated: April 12, 2012
Health Authority: United States: Federal Government

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:
Hypertension
Kidney Diseases
Hypertension, Renal
Vascular Diseases
Cardiovascular Diseases
Urologic Diseases
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 29, 2014