Clinical trial NCT05159999: The Home Blood Pressure (BP) Trial
Official title: The Home Blood Pressure (BP) Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: End Stage Renal Disease on Dialysis
Keywords: Blood pressure, dialysis
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: University of California, San Francisco
name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2021-12-16
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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.

Eligibility 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)

Primary outcomes:
measure: Intradialytic hypotension (IDH), defined as systolic blood pressure<90 mmHg during dialysis
timeFrame: 10 months
Secondary outcomes:
measure: Fatigue by SONG-HD Score
timeFrame: 10 months
measure: Cramping
timeFrame: 10 months
measure: Rates of hospitalizations for cardiovascular events and volume overload
timeFrame: 10 months
measure: Correlation between pre-dialysis and home SBP
timeFrame: 10 months
Other outcomes:
measure: Separation of blood pressures
timeFrame: 2 months
Locations:
city: San Francisco
country: United States
facility: University of California San Francisco
state: California
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: University of Washington
name: Nisha Bansal, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, San Francisco
name: Chi-yuan Hsu, MD
role: PRINCIPAL_INVESTIGATOR
References: