The Home Blood Pressure (BP) Trial

a study on Dialysis End Stage Renal Disease Kidney Disease Chronic Kidney Disease

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
completion around
Principal Investigator
by Chi-yuan Hsu, MD

Description

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.

Details

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.

Keywords

End Stage Renal Disease on Dialysis, Blood pressure, dialysis, Chronic Kidney Failure, Antihypertensive Agents, Dry weight target adjustment, Anti-hypertensive medications, Home Systolic Blood Pressure <140 mmHg, Pre-Dialysis Systolic Blood Pressure <140 mmHg, Home Systolic Blood Pressure <130 mmHg

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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

You CAN'T join if...

  • 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)

Locations

  • UCSF accepting new patients
    San Francisco California 94143 United States
  • University of Washington accepting new patients
    Seattle Washington 98104 United States

Lead Scientist at UCSF

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of Washington
ID
NCT05159999
Study Type
Interventional
Participants
Expecting 200 study participants
Last Updated
Contact us about this trial