African American Study Of Kidney Disease And Hypertension
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Complete Title of Study
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)
Study Acronym (The trial’s abbreviation if there is one)
AASK
Principal Investigator, Co-investigators, and Collaborating Institutions
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
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.)
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
Study Phase (e.g. Phase I,II,III,IV) Study Phases are defined here
Phase II, Phase III
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]
Phase I Trials
These are initial studies to determine the metabolism and pharmacologic actions of drugs in humans (what are called PK/PD studies or pharmacokinetic / pharmacodynamic studies), the side effects associated with increasing doses (a dose response curve or dose response relationship), and to gain early evidence of effectiveness; may include healthy participants and/or patients. These are sometimes called a first in man study.
Phase II Trials
Controlled clinical studies conducted to evaluate the effectiveness of the drug for a particular indication or indications in patients with the disease or condition under study and to determine the common short-term side effects and risks. Sometimes multiple doses will be studied in these trials to select the appropriate dose for further testing in phase III. These are sometimes called a dose finding study.
Phase III Trials
Expanded controlled and uncontrolled trials after preliminary evidence suggesting effectiveness of the drug has been obtained, and are intended to gather additional information to evaluate the overall benefit-risk relationship of the drug and provide and adequate basis for physician labeling. These are also called pivotal trials.
Phase IV Trials
After the drug has been approved by a regulatory agency, these are post-marketing studies to delineate additional information including the drug’s risks,benefits, and optimal use in a broader group of real world patients.
Study Design (e.g. multicenter, randomized, double blind, placebo controlled)
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)
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.
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]
In a clinical study, participants are often divided into groups.
In interventional studies, participants are prospectively assigned to arms and receive different interventions. Assignment to an arm is typically random. Multiple arms allow the effects of different interventions to be compared. Participants in a control arm may receive no intervention, placebo, or an intervention with a known effect.
In observational studies, a pre-defined population may be observed over time and is termed, a cohort. A cohort consists of individuals with some common characteristic(s), for example, age, place of residence/employment, or medical condition. A cohort is observed over time to determine if the presence or absence of an exposure is associated with a health outcome or condition. Other observational studies may compare those with a condition (cases) to those without a condition (control) and evaluate differences in exposures, treatments, or behaviors. The cases and controls may be selected from a larger population or a cohort.
Source
Primary Pre-Specified Endpoint
Primary Pre-Specified Endpoint
Night time blood pressure (time frame: night time blood pressure from APBM at weeks 6, 12, and 18)
Secondary Endpoints
Secondary Endpoints
Blood pressure in the clinic daytime blood pressure (time frame: measured at weeks 6, 12, and 18)
Inclusion 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 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
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)
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)
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)
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)
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)
Conclusions of the Investigators (Quote the investigators conclusions here)
None reported
Commentary, Discussion and Limitations of the Trial (Anyone can add comments)
Commentary, Discussion and Limitations of the Trial (Anyone can add comments)
None reported
Slides
Slides
None reported
Video Commentary
Video Commentary
None reported
External sites for further information (How to insert links)
External sites for further information (How to insert links)
None reported
Detailed information about the trial
Detailed information about the trial
None reported
Ages
Ages
18 years and older
Gender (Indicate whether men, women or both were enrolled)
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)
Accepts Healthy Volunteers (Answer yes or no)
No
Enrollment Period (Study start and end date)
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)
Recruitment Status (explanation)
Study has been completed
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]
Recruitment status indicates the current stage of a trial, whether it is planned, ongoing, or completed. Possible values include:
- Not yet recruiting: participants are not yet being recruited or enrolled
- Recruiting: participants are currently being recruited and enrolled
- Enrolling by invitation: participants are being (or will be) selected from a predetermined population
- Active, not recruiting: study is ongoing (i.e., patients are being treated or examined), but enrollment has completed
- Completed: the study has concluded normally; participants are no longer being examined or treated (i.e., last patient’s last visit has occurred)
- Suspended: recruiting or enrolling participants has halted prematurely but potentially will resume
- Terminated: recruiting or enrolling participants has halted prematurely and will not resume; participants are no longer being examined or treated
- Withdrawn: study halted prematurely, prior to enrollment of first participant
Enrollment (Total number of patients enrolled)
Enrollment (Total number of patients enrolled)
180
Study Sponsor (e.g. Investigator initiated or company name)
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)
Source of Data (Where is this data on this page coming from: publication, principal investigator, or co-investigator)
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