Comparing home and pre-dialysis blood pressure management for patients on dialysis
The Home Blood Pressure (BP) Trial
This study is testing whether managing blood pressure at home or before dialysis helps people with kidney failure avoid low blood pressure during their treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Washington Academic / other |
| Locations | 2 sites (San Francisco, California and 1 other locations) |
| Trial ID | NCT05159999 on ClinicalTrials.gov |
What this trial studies
This clinical trial is a two-arm, 10-month, cross-over randomized controlled trial involving 200 participants with end-stage renal disease undergoing in-center hemodialysis in Seattle and San Francisco. It aims to compare the effectiveness of targeting home versus pre-dialysis systolic blood pressure below 140 mmHg in reducing rates of intradialytic hypotension. Participants will have their blood pressure managed through an algorithm involving dry weight adjustments and anti-hypertensive medication adjustments, with home blood pressure measurements recorded via a mobile health monitor throughout the study period.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who are undergoing in-center hemodialysis for end-stage renal disease and have hypertension.
Not a fit: Patients who are incarcerated, pregnant, or participating in another intervention study that may affect blood pressure are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved blood pressure management and reduced complications for patients undergoing dialysis.
How similar studies have performed: Previous studies have shown promising results in managing blood pressure in dialysis patients, suggesting that this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Aged 18 years or older * Undergoing in-center, thrice weekly hemodialysis for treatment of end stage renal disease (ESRD) * Greater than 3 months since initiation of dialysis * No anticipated change to peritoneal dialysis or kidney transplant within 10 months * Life expectancy greater than 10 months * Hypertension (defined as mean pre-dialysis SBP \> 140 mmHg over prior 2 weeks or taking BP medications) * Able to obtain/measure a brachial blood pressure at dialysis and at home (e.g., no left ventricular assist device, blood pressure not been taken routinely in lower extremity at dialysis unit) * No condition that the primary nephrologist or PIs feel precludes participation Exclusion Criteria: * Incarcerated or institutionalized (prohibits home blood pressure measurement) * Participating in another intervention study that may affect blood pressure * Pregnant or anticipated pregnancy or breastfeeding (as this will require increase to more than three times a week dialysis and/or preclude use of some classes of blood pressure medications)
Where this trial is running
San Francisco, California and 1 other locations
- University of California San Francisco — San Francisco, California, United States (Recruiting)
- University of Washington — Seattle, Washington, United States (Recruiting)
Study contacts
- Principal investigator: Nisha Bansal, MD — University of Washington
- Study coordinator: Nisha Bansal, MD
- Email: nbansal@uw.edu
- Phone: 206-221-1801
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.