The Home Blood Pressure (BP) Trial

NCT ID: NCT05159999

Last Updated: 2025-10-14

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-02
• Study Completion Date: 2026-04-30

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.

Conditions

End Stage Renal Disease on Dialysis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Dry weight target adjustment

Intervention Type: OTHER

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

Anti-hypertensive medications

Intervention Type: 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.

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.

Group Type: ACTIVE_COMPARATOR

Dry weight target adjustment

Intervention Type: OTHER

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

Anti-hypertensive medications

Intervention Type: 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

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.

Group Type: OTHER

Dry weight target adjustment

Intervention Type: OTHER

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

Anti-hypertensive medications

Intervention Type: 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.

Interventions

Dry weight target adjustment

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

Intervention Type: OTHER

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.

Intervention Type: DRUG

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of California, San Francisco

OTHER

Sponsor Role: collaborator

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role: collaborator

University of Washington

OTHER

Sponsor Role: lead

Responsible Party

Nisha Bansal

Associate Professor, Division of Nephrology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nisha Bansal, MD

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Chi-yuan Hsu, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

University of California San Francisco

San Francisco, California, United States

University of Washington

Seattle, Washington, United States

Countries

United States

Other Identifiers

R01DK123104

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00012367

Identifier Type: -

Identifier Source: org_study_id