African American Study Of Kidney Disease And Hypertension

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How to edit trial information: Log in, click on the word [edit] to the right of the section you would like to edit, type in the appropriate information, click save page at the bottom when you are done. The template is the minimum elements required by the World Health Organization. You can add additional sections. More help to add a trial here.


Complete Title of Study

African American Study of Kidney Disease and Hypertension ABPM Pilot Study

Study Acronym (The trial's abbreviation if there is one)

AASK

Principal Investigator, Co-investigators, and Collaborating Institutions

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

Study Chair: Mahboob Rahman, M.D. Institution: University Hospitals, Cleveland

Principal Investigator: Jackson T. Wright, Jr., MD, Ph.D., FACP Institution: University Hospitals of Cleveland

Principal Investigator: Janice Lea, MD Institution: Emory Center for Hypertension and Renal Disease Research

Principal Investigator: Francis B. Gabbai, MD Institution: University of California, San Diego

Principal Investigator: Otelio S. Randall, MD Institution: Howard University

Principal Investigator: Lawrence Appel, MD, MPH Institution: Johns Hopkins University

Principal Investigator: Keith Norris, MD Institution: Charles Drew Medical Center

Principal Investigator: DeAnna Cheek, MD Institution: Medical University of South Carolina

Principal Investigator: Michael Lipkowitz, MD Institution: Lenox Hill Hospital

Principal Investigator: Lee Hebert, MD Institution: Ohio State University

Principal Investigator: George Bakris, MD Institution: University of Chicago

Principal Investigator: Stephen G. Rostand, MD Institution: University of Alabama at Birmingham

Principal Investigator: Geraldine Bichier, MD Institution: University of Florida

Principal Investigator: Gabriel Contreras, MD Institution: University of Miami

Principal Investigator: Kenneth Jamerson, MD Institution: University of Michigan

Principal Investigator: Miroslav J. Smogorzewski, MD Institution: University of Southern California

Principal Investigator: Robert D. Toto, MD Institution: University of Texas Southwestern Medical Center at Dallas

Principal Investigator: Julia A. Lewis, MD Institution: Vanderbilt University

Overview of Trial

This pilot study began after the last scheduled AASK Cohort study visit. Eligible participants were treated for 6 weeks on each of 3 antihypertensive regimens. The sequence of the regimens was random. Each period of the three periods had 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 was obtained. The primary outcome variable was nocturnal BP; each pair wise difference between the regimens was calculated.

The study was 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 were on an ACE inhibitor or angiotensin receptor blocker; the most commonly used ACE inhibitor is ramipril. The strategies used in this pilot study remained ramipril-based, to maintain the overall blood pressure control achieved up until the start of the cohort study.

The antihypertensive regimens were 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)

  • 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" served as the comparator arm. The "hs dosing" and "add-on dosing" arms tested practical strategies that could be tested in a subsequent clinical outcomes trial and that could be implemented in clinical practice. Investigators hypothesized that both arms would reduce nocturnal BP in comparison to "usual dosing". They further hypothesized that the "hs dosing" arm would raise daytime BP somewhat but have no net effect on 24 hour BP and that the "add on dosing" arm would have no effect on daytime BP but lower 24 hour BP.

Disease State(s) Studied (e.g. acute MI, breast cancer, etc.)

Hypertensive Renal Disease

Study Phase (e.g. Phase I,II,III,IV) Study Phases are defined here

Phase II, Phase III

Study Design (e.g. multicenter, randomized, double blind, placebo controlled)

Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Efficacy Study

Study Arms and How They Were Treated (Intervention) (Explanation here)

180 were randomized to 3 different treatment arms:

  • The USUAL arm: Active Comparator
    • USUAL treatment - The patient's antihypertensive regimen at the baseline visit was the comparison (or control) regimen. All once a day medications were administered in the morning.
  • The HS Dosing arm: Experimental
    • In this period, the patient's antihypertensive regimen at the baseline visit was standardized for the once/day medications to be given at bedtime.
  • The ADD-ON DOSING arm: Experimental
    • This regimen started with the USUAL regimen to which an additional agent (ramipril, diltiazem, or hydralazine) was added at bed time. The intent of the ADD ON therapy was to lower nocturnal BP with minimal impact on daytime BP. Thus, agents with < 24 hr duration of action were preferred. The specific choice and dose of add-on therapy (of the three agents) was up to the site investigator considering the clinical situation of each participant.

Primary Pre-Specified Endpoint

Night time blood pressure (time frame: night time blood pressure from APBM at weeks 6, 12, and 18)

Secondary Endpoints

Blood pressure in the clinic daytime blood pressure (time frame: measured at weeks 6, 12, and 18)

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 excluded a small percentage of the AASK cohort population; however, it enrolled 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

Outcome: Primary endpoint (Report both relative risk reduction and absolute risk reduction as well as number needed to treat if available)

None reported

Outcome: Secondary endpoint (Report both relative risk reduction and absolute risk reduction as well as number needed to treat if available)

None reported

Outcome: Exploratory endpoints (Report both relative risk reduction and absolute risk reduction as well as number needed to treat if available)

None reported

Outcome: Safety endpoints (Report both relative risk and absolute risk as well as number needed to harm if available)

None reported

Conclusions of the Investigators (Quote the investigators conclusions here)

None reported

Commentary, Discussion and Limitations of the Trial (Anyone can add comments)

None reported

Slides

None reported

Video Commentary

None reported

References (How to insert a reference)

None reported

External sites for further information (How to insert links)

None reported

Detailed information about the trial

None reported

Ages

18 years and older

Gender (Indicate whether men, women or both were enrolled)

Both men and women were eligible for the study

Accepts Healthy Volunteers (Answer yes or no)

No

Enrollment Period (Study start and end date)

Study start date: November 2007

Study completion date: December 2008

Primary completion date: December 2008 (Final data collection date for primary outcome measure)

Recruitment Status (explanation)

Study has been completed

Enrollment (Total number of patients enrolled)

180

Study Sponsor (e.g. Investigator initiated or company name)

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

Source of Data (Where is this data on this page coming from: publication, principal investigator, or co-investigator)

The content of the clinical trial wiki consists of fields that have been suggested by the World Health Organization and wwww.clinicaltrials.gov.




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