The Home Blood Pressure (BP) Trial

Not Applicable

Recruiting

• Conditions: End Stage Renal Disease on Dialysis
• Interventions: Other: Dry weight target adjustment; Drug: Anti-hypertensive medications

• Registration Number: NCT05159999
• Lead Sponsor: University of Washington

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.

Study Timeline

• Study First Submitted: 2021-11-18
• Study First Submitted QC: 2021-12-02
• Study First Posted: 2021-12-16
• Study Start: 2022-02-02
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-04
• Last Update Posted: 2024-12-10
• Primary Completion: 2026-04-30
• Study Completion: 2026-04-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Home Systolic Blood Pressure <130 mmHg	Anti-hypertensive medications	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.
Pre-Dialysis Systolic Blood Pressure <140 mmHg	Anti-hypertensive medications	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.
Home Systolic Blood Pressure <140 mmHg	Dry weight target adjustment	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.
Home Systolic Blood Pressure <140 mmHg	Anti-hypertensive medications	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.
Home Systolic Blood Pressure <130 mmHg	Dry weight target adjustment	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.
Pre-Dialysis Systolic Blood Pressure <140 mmHg	Dry weight target adjustment	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Fatigue by SONG-HD Score	10 months	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)
Rates of hospitalizations for cardiovascular events and volume overload	10 months	Test the effect of treating home SBP \<140mmHg vs a pre-dialysis SBP \<140mmHg on rates of hospitalizations for cardiovascular events and volume overload
Cramping	10 months	Test the effect of treating home SBP \<140mmHg vs a pre-dialysis SBP \<140mmHg on frequency of cramping
Correlation between pre-dialysis and home SBP	10 months	Evaluate the correlation between pre-dialysis and home SBP under different treatment strategies

Trial Locations

Locations (2)

University of California San Francisco; 🇺🇸 San Francisco, California, United States

University of Washington; 🇺🇸 Seattle, Washington, United States