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The Home Blood Pressure (BP) Trial


Description

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.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 tw

Trial Eligibility

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 Info

Organization

University of Washington


Primary Outcome

Intradialytic hypotension (IDH), defined as systolic blood pressure<90 mmHg during dialysis


Outcome Timeframe 10 months

NCTID NCT05159999

Phases NA

Primary Purpose TREATMENT

Start Date 2022-02-02

Completion Date 2026-04-30

Enrollment Target 200

Interventions

OTHER Dry weight target adjustment

DRUG Anti-hypertensive medications

Locations Recruiting

University of California San Francisco

United States, California, San Francisco


University of Washington

United States, Washington, Seattle


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