The Home Blood Pressure (BP) Trial

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Home Blood Pressure (BP) Trial

Conditions
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End Stage Renal Disease on Dialysis

Intervention / Treatment
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* Other: Dry weight target adjustment
* Drug: Anti-hypertensive medications


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Home Systolic Blood Pressure <140 mmHg<br>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<br>* Target dry weight will be adjusted every 2 weeks to reach the home or pre-dialysis systolic blood pressure target.<br>Drug: Anti-hypertensive medications<br>* 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.<br>|
| Active Comparator: Pre-Dialysis Systolic Blood Pressure <140 mmHg<br>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<br>* Target dry weight will be adjusted every 2 weeks to reach the home or pre-dialysis systolic blood pressure target.<br>Drug: Anti-hypertensive medications<br>* 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.<br>|
| Other: Home Systolic Blood Pressure <130 mmHg<br>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<br>* Target dry weight will be adjusted every 2 weeks to reach the home or pre-dialysis systolic blood pressure target.<br>Drug: Anti-hypertensive medications<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Blood pressure, dialysis