Clinical Trial: African American Study of Kidney Disease and Hypertension ABPM Pilot Study

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: African American Study of Kidney Disease and Hypertension ABPM Pilot Study

Brief 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 pil

Detailed Summary:
Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Current Primary Outcome: Night Time Blood Pressure [ Time Frame: Night time blood pressure from APBM at weeks 6, 12, and 18 ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Blood pressure in the clinic Daytime blood pressure [ Time Frame: Measured at weeks 6, 12, and 18 ]

Original Secondary Outcome: Same as current

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

Dates:
Date Received: December 20, 2007
Date Started: November 2007
Date Completion:
Last Updated: April 12, 2012
Last Verified: April 2012