Hypertensive Renal Disease Clinical Trial
Official title:
African American Study of Kidney Disease and Hypertension ABPM Pilot Study
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.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment