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Anti-hypertensive medication

Blood Pressure Management for Chronic Kidney Failure (Home-BP Trial)

N/A

Recruiting

Led By Nisha Bansal, MD

Research Sponsored by University of Washington

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Hypertension (defined as mean pre-dialysis SBP > 140 mmHg over prior 2 weeks or taking BP medications)

Undergoing in-center, thrice weekly hemodialysis for treatment of end stage renal disease (ESRD)

Must not have

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)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 10 months

Awards & highlights

No Placebo-Only Group

Summary

This trial will compare two different strategies for managing blood pressure in people with end-stage kidney disease who are receiving hemodialysis. One group will target a systolic blood pressure of <140 mmHg before dialysis, and the other group will target a systolic blood pressure of <140 mmHg at home. The trial will last 10 months and will involve 200 participants in the Seattle and San Francisco area.

Who is the study for?

This trial is for adults over 18 with chronic kidney failure or disease, on in-center hemodialysis for at least 3 months, and have high blood pressure. They must be able to measure their BP at home and dialysis, not expecting a kidney transplant or change in treatment within 10 months, and not part of another study that affects BP.

What is being tested?

The study compares two methods to manage blood pressure in patients undergoing hemodialysis: one targets home-measured systolic BP <140 mmHg while the other focuses on pre-dialysis measurements. Both use dry weight adjustments and anti-hypertensive meds following an algorithm.

What are the potential side effects?

Potential side effects may include changes in blood pressure leading to intradialytic hypotension (low blood pressure during dialysis), dizziness, fatigue, or complications from medication adjustments like electrolyte imbalances.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have high blood pressure or am on medication for it.

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I am receiving hemodialysis three times a week for kidney failure.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not pregnant, planning to become pregnant, or breastfeeding.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 10 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~10 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 10 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

Correlation between pre-dialysis and home SBP

Cramping

Fatigue by SONG-HD Score

+1 more

Other study objectives

Separation of blood pressures

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Home Systolic Blood Pressure <140 mmHgExperimental Treatment2 Interventions

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 II: Home Systolic Blood Pressure <130 mmHgExperimental Treatment2 Interventions

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 III: Pre-Dialysis Systolic Blood Pressure <140 mmHgActive Control2 Interventions

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.

0 / 4Eligibility criteria met