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Active Not RecruitingNCT05159999

The Home Blood Pressure (BP) Trial

Status
Active Not Recruiting
Phase
N/A
Study type
Interventional
Enrollment
200 (estimated)
Sponsor
University of Washington · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

The main study will be a two arm 10-month, cross-over randomized controlled trial of 200 participants treated with end-stage-kidney-disease treated with in-center hemodialysis in the Seattle and San Francisco area comparing a strategy of targeting home vs. pre-dialysis systolic blood pressure \<140 mmHg to reduce rates of intradialytic hypotension. The target systolic blood pressure of \<140 mmHg in both treatment groups will be achieved using an algorithm of dry weight adjustment and anti-hypertensive medication adjustment.

Detailed description

The main study be a two arm 10-month, cross-over randomized controlled trial of 200 participants treated with in-center hemodialysis in the Seattle and San Francisco area comparing a strategy of targeting home vs. pre-dialysis systolic blood pressure \<140 mmHg in reducing rates of intradialytic hypotension. The target systolic blood pressure of 100-140 mmHg will be achieved using an algorithm of volume management and anti-hypertensive medication adjustment every two weeks. Home blood pressure measures will be recorded throughout via a mobile health blood pressure monitor over the 10-month study.

Conditions

Interventions

TypeNameDescription
OTHERDry weight target adjustmentTarget dry weight will be adjusted every 2 weeks to reach the home or pre-dialysis systolic blood pressure target.
DRUGAnti-hypertensive medicationsAnti-hypertensive medications will be adjusted every 2 weeks to reach the home or pre-dialysis systolic blood pressure target. Adjustment of currently prescribed anti-hypertensive medications will be prioritized before starting new medications. Only standard anti-hypertensive medications will be used, such as RAAS inhibitors, beta-blockers, calcium channel blockers and diuretics.

Timeline

Start date
2022-02-02
Primary completion
2026-04-30
Completion
2026-04-30
First posted
2021-12-16
Last updated
2025-10-14

Locations

2 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT05159999. Inclusion in this directory is not an endorsement.