The Home Blood Pressure (BP) Trial (Home-BP)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: End Stage Renal Disease on Dialysis
• Intervention / Treatment: Other: Dry weight target adjustment; Drug: Anti-hypertensive medications

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.

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94143
      • University of California San Francisco
  • Washington
    • Seattle, Washington, United States, 98104
      • University of Washington

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Home Systolic Blood Pressure <140 mmHg; Participants will take their home blood pressure two times per week (one in the morning and one in the evening) on non-dialysis days, ideally mid-week. Home blood pressures will be reviewed every two weeks and dry weight and medications adjusted accordingly to reach a home systolic blood pressure target of <140 mmHg.	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.
Active Comparator: Pre-Dialysis Systolic Blood Pressure <140 mmHg; Participants will have their blood pressure taken by an automated blood pressure device by dialysis unit staff using regular dialysis unit equipment according to usual clinical care. Pre-dialysis blood pressures will be reviewed every two weeks and dry weight and medications adjusted accordingly to reach a pre-dialysis systolic blood pressure target of <140 mmHg.	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.
Other: Home Systolic Blood Pressure <130 mmHg; This will be an optional, exploratory 2 month study at the end of the primary 10-month trial. Participants will take their home blood pressure two times per week (one in the morning and one in the evening) on non-dialysis days, ideally mid-week. Home blood pressures will be reviewed every two weeks and dry weight and medications adjusted accordingly to reach a home systolic blood pressure target of <130 mmHg.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intradialytic hypotension (IDH), defined as systolic blood pressure<90 mmHg during dialysis	Test the effect of treating home SBP <140mmHg vs a pre-dialysis SBP <140mmHg on rates of IDH	10 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fatigue by SONG-HD Score	Test the effect of treating home SBP <140mmHg vs a pre-dialysis SBP <140mmHg on patient reported fatigue, as ascertained by the SONG-HD Fatigue Score (PMID: 33093215)	10 months
Cramping	Test the effect of treating home SBP <140mmHg vs a pre-dialysis SBP <140mmHg on frequency of cramping	10 months
Rates of hospitalizations for cardiovascular events and volume overload	Test the effect of treating home SBP <140mmHg vs a pre-dialysis SBP <140mmHg on rates of hospitalizations for cardiovascular events and volume overload	10 months
Correlation between pre-dialysis and home SBP	Evaluate the correlation between pre-dialysis and home SBP under different treatment strategies	10 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Separation of blood pressures	Determine whether the intervention is able to achieve a home systolic blood pressure <130mmHg in this optional study.	2 months

Collaborators and Investigators

• Sponsor: University of Washington
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); University of California, San Francisco
• Investigators: Principal Investigator: Nisha Bansal, MD, University of Washington; Principal Investigator: Chi-yuan Hsu, MD, University of California, San Francisco

Study record dates

Study Major Dates

• Study Start (Actual): February 2, 2022
• Primary Completion (Estimated): April 30, 2026
• Study Completion (Estimated): April 30, 2026

Study Registration Dates

• First Submitted: November 18, 2021
• First Submitted That Met QC Criteria: December 2, 2021
• First Posted (Actual): December 16, 2021

Study Record Updates

• Last Update Posted (Estimated): October 14, 2025
• Last Update Submitted That Met QC Criteria: October 10, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: Blood pressure, dialysis
• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Renal Insufficiency; Renal Insufficiency, Chronic; Kidney Failure, Chronic; Antihypertensive Agents
• Other Study ID Numbers: STUDY00012367; R01DK123104 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No