The Home Blood Pressure (BP) Trial

NCT05159999 | Active Not Recruiting DMC

• 2 other identifiers: STUDY00012367R01DK123104
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 2

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.

Conditions

End Stage Renal Disease on Dialysis

Keywords

Blood pressure, dialysis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Fatigue by SONG-HD Score

  10 months

• Cramping

  10 months

• Rates of hospitalizations for cardiovascular events and volume overload

  10 months

• Correlation between pre-dialysis and home SBP

  10 months

Other Outcomes (1)

• Separation of blood pressures

  2 months

Study Arms (3)

Home Systolic Blood Pressure <140 mmHg

EXPERIMENTAL

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; Drug: Anti-hypertensive medications

Pre-Dialysis Systolic Blood Pressure <140 mmHg

ACTIVE COMPARATOR

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; Drug: Anti-hypertensive medications

Home Systolic Blood Pressure <130 mmHg

OTHER

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; Drug: Anti-hypertensive medications

Interventions

Dry weight target adjustment OTHER

Target dry weight will be adjusted every 2 weeks to reach the home or pre-dialysis systolic blood pressure target.

Home Systolic Blood Pressure <130 mmHg; Home Systolic Blood Pressure <140 mmHg; Pre-Dialysis Systolic Blood Pressure <140 mmHg

Anti-hypertensive medications DRUG

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.

Home Systolic Blood Pressure <130 mmHg; Home Systolic Blood Pressure <140 mmHg; Pre-Dialysis Systolic Blood Pressure <140 mmHg

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 may not qualify 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)

Sponsors & Collaborators

• University of Washington: lead
• University of California, San Francisco: collaborator
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (2)

University of California San Francisco

San Francisco, California, 94143, United States

Location

University of Washington

Seattle, Washington, 98104, United States

Location

Study Officials

• Nisha Bansal, MD

  University of Washington

  PRINCIPAL INVESTIGATOR

• Chi-yuan Hsu, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Division of Nephrology

Study Record Dates

• First Submitted: November 18, 2021
• First Posted: December 16, 2021
• Study Start: February 2, 2022
• Primary Completion: April 30, 2026
• Study Completion: April 30, 2026
• Last Updated: October 14, 2025

Record last verified: 2025-10

Locations

US (2)