Trials / Active Not Recruiting
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
| Type | Name | Description |
|---|---|---|
| OTHER | Dry weight target adjustment | Target dry weight will be adjusted every 2 weeks to reach the home or pre-dialysis systolic blood pressure target. |
| DRUG | Anti-hypertensive medications | Anti-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.