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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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 10 months
Awards & highlights

Home-BP Trial 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.Check my eligibility
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.See study design
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.

Home-BP Trial 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 not expected to undergo peritoneal dialysis or a kidney transplant within the next 10 months.
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I am 18 years old or older.
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I started dialysis more than 3 months ago.

Home-BP Trial Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Intradialytic hypotension (IDH), defined as systolic blood pressure<90 mmHg during dialysis
Secondary outcome measures
Correlation between pre-dialysis and home SBP
Cramping
Fatigue by SONG-HD Score
+1 more
Other outcome measures
Separation of blood pressures

Home-BP 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.

Find a Location

Who is running the clinical trial?

University of California, San FranciscoOTHER
2,496 Previous Clinical Trials
11,933,289 Total Patients Enrolled
University of WashingtonLead Sponsor
1,732 Previous Clinical Trials
1,841,914 Total Patients Enrolled
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,346 Previous Clinical Trials
4,314,208 Total Patients Enrolled

Media Library

Anti-hypertensive medications (Anti-hypertensive medication) Clinical Trial Eligibility Overview. Trial Name: NCT05159999 — N/A
Kidney Disease Research Study Groups: Pre-Dialysis Systolic Blood Pressure <140 mmHg, Home Systolic Blood Pressure <130 mmHg, Home Systolic Blood Pressure <140 mmHg
Kidney Disease Clinical Trial 2023: Anti-hypertensive medications Highlights & Side Effects. Trial Name: NCT05159999 — N/A
Anti-hypertensive medications (Anti-hypertensive medication) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05159999 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this experimental program still open to enrollment?

"Clinicaltrials.gov confirms that this ongoing medical study is currently recruiting patients, with initial posting occurring on February 2nd 2022 and most recent edits being made June 2nd 2022."

Answered by AI

How many individuals can partake in this medical experiment?

"Right. Clinicaltrials.gov's data suggest that this medical research beginning on February 2nd 2022 is actively recruiting for 200 patients from two separate sites. The trial was last updated on June 2nd of the same year."

Answered by AI
~100 spots leftby Apr 2026