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
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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.
|
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
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 Hospital Case 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
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 Hypertension, Renal Kidney Diseases Nephritis Cardiovascular Diseases Urologic Diseases |
Vascular Diseases Antihypertensive Agents Cardiovascular Agents Pharmacologic Actions Therapeutic Uses |
ClinicalTrials.gov processed this record on February 25, 2015