Home-BP: The Home Blood Pressure (BP) Trial

Sponsor

University of Washington (Other)

Overall Status

Recruiting

CT.gov ID

NCT05159999

Collaborator

University of California, San Francisco (Other), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (NIH)

200

Enrollment

Locations

Arms

50.9

Anticipated Duration (Months)

100

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
End Stage Renal Disease on Dialysis	Other: Dry weight target adjustment Drug: Anti-hypertensive medications	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

200 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

The Home Blood Pressure (BP) Trial

Actual Study Start Date :

Feb 2, 2022

Anticipated Primary Completion Date :

Apr 30, 2026

Anticipated Study Completion Date :

Apr 30, 2026

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Home Systolic Blood Pressure <140 mmHg

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

Target dry weight will be adjusted every 2 weeks to reach the home or pre-dialysis systolic blood pressure target.

Drug: Anti-hypertensive medications

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.

Active Comparator: Pre-Dialysis Systolic Blood Pressure <140 mmHg

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

Target dry weight will be adjusted every 2 weeks to reach the home or pre-dialysis systolic blood pressure target.

Drug: Anti-hypertensive medications

Other: Home Systolic Blood Pressure <130 mmHg

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

Target dry weight will be adjusted every 2 weeks to reach the home or pre-dialysis systolic blood pressure target.

Drug: Anti-hypertensive medications

Outcome Measures

Primary Outcome Measures

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

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)
Cramping [10 months]
Test the effect of treating home SBP <140mmHg vs a pre-dialysis SBP <140mmHg on frequency of cramping
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
Correlation between pre-dialysis and home SBP [10 months]
Evaluate the correlation between pre-dialysis and home SBP under different treatment strategies

Other Outcome Measures

Separation of blood pressures [2 months]
Determine whether the intervention is able to achieve a home systolic blood pressure <130mmHg in this optional study.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of California San Francisco	San Francisco	California	United States	94143
2	University of Washington	Seattle	Washington	United States	98104

Sponsors and Collaborators

University of Washington
University of California, San Francisco
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Investigators

Principal Investigator: Nisha Bansal, MD, University of Washington
Principal Investigator: Chi-yuan Hsu, MD, University of California, San Francisco

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Nisha Bansal, Associate Professor, Division of Nephrology, University of Washington

ClinicalTrials.gov Identifier:

NCT05159999

Other Study ID Numbers:

STUDY00012367
R01DK123104

First Posted:

Dec 16, 2021

Last Update Posted:

Jun 6, 2022

Last Verified:

Jun 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Nisha Bansal, Associate Professor, Division of Nephrology, University of Washington

Blood pressure, dialysis

Additional relevant MeSH terms:

Kidney Failure, Chronic

Antihypertensive Agents

Study Results

No Results Posted as of Jun 6, 2022