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

University of Washington

Status: Active, not recruiting

Conditions: End Stage Renal Disease on Dialysis

Treatments: Drug: Anti-hypertensive medications; Other: Dry weight target adjustment

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05159999

STUDY00012367

R01DK123104 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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200 participants in 3 patient groups

Home Systolic Blood Pressure <140 mmHg

Experimental group

Description:

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.

Treatment:

Other: Dry weight target adjustment

Drug: Anti-hypertensive medications

Pre-Dialysis Systolic Blood Pressure <140 mmHg

Active Comparator group

Description:

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.

Treatment:

Other: Dry weight target adjustment

Drug: Anti-hypertensive medications

Home Systolic Blood Pressure <130 mmHg

Other group

Description:

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.

Treatment:

Other: Dry weight target adjustment

Drug: Anti-hypertensive medications