African American Study of Kidney Disease and Hypertension ABPM Pilot Study (NCT00582777) | Clinical Trial Compass
CompletedPhase 2/3
African American Study of Kidney Disease and Hypertension ABPM Pilot Study
United States180 participantsStarted 2007-11
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Night Time Blood Pressure
Timeframe: Night time blood pressure from APBM at weeks 6, 12, and 18
Trial details
NCT IDNCT00582777
SponsorNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)