search
Back to results

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

Primary Purpose

End Stage Renal Disease on Dialysis

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Dry weight target adjustment
Anti-hypertensive medications
Sponsored by
University of Washington
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for End Stage Renal Disease on Dialysis focused on measuring Blood pressure, dialysis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

  • University of California San FranciscoRecruiting
  • University of WashingtonRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Other

Arm Label

Home Systolic Blood Pressure <140 mmHg

Pre-Dialysis Systolic Blood Pressure <140 mmHg

Home Systolic Blood Pressure <130 mmHg

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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)
Cramping
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
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
Evaluate the correlation between pre-dialysis and home SBP under different treatment strategies

Full Information

First Posted
November 18, 2021
Last Updated
June 2, 2022
Sponsor
University of Washington
Collaborators
University of California, San Francisco, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
search

1. Study Identification

Unique Protocol Identification Number
NCT05159999
Brief Title
The Home Blood Pressure (BP) Trial
Acronym
Home-BP
Official Title
The Home Blood Pressure (BP) Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 2, 2022 (Actual)
Primary Completion Date
April 30, 2026 (Anticipated)
Study Completion Date
April 30, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington
Collaborators
University of California, San Francisco, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End Stage Renal Disease on Dialysis
Keywords
Blood pressure, dialysis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Home Systolic Blood Pressure <140 mmHg
Arm Type
Experimental
Arm Description
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.
Arm Title
Pre-Dialysis Systolic Blood Pressure <140 mmHg
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Home Systolic Blood Pressure <130 mmHg
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Dry weight target adjustment
Intervention Description
Target dry weight will be adjusted every 2 weeks to reach the home or pre-dialysis systolic blood pressure target.
Intervention Type
Drug
Intervention Name(s)
Anti-hypertensive medications
Intervention Description
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.
Primary Outcome Measure Information:
Title
Intradialytic hypotension (IDH), defined as systolic blood pressure<90 mmHg during dialysis
Description
Test the effect of treating home SBP <140mmHg vs a pre-dialysis SBP <140mmHg on rates of IDH
Time Frame
10 months
Secondary Outcome Measure Information:
Title
Fatigue by SONG-HD Score
Description
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)
Time Frame
10 months
Title
Cramping
Description
Test the effect of treating home SBP <140mmHg vs a pre-dialysis SBP <140mmHg on frequency of cramping
Time Frame
10 months
Title
Rates of hospitalizations for cardiovascular events and volume overload
Description
Test the effect of treating home SBP <140mmHg vs a pre-dialysis SBP <140mmHg on rates of hospitalizations for cardiovascular events and volume overload
Time Frame
10 months
Title
Correlation between pre-dialysis and home SBP
Description
Evaluate the correlation between pre-dialysis and home SBP under different treatment strategies
Time Frame
10 months
Other Pre-specified Outcome Measures:
Title
Separation of blood pressures
Description
Determine whether the intervention is able to achieve a home systolic blood pressure <130mmHg in this optional study.
Time Frame
2 months

10. Eligibility

Sex
All
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nisha Bansal, MD
Phone
206-221-1801
Email
nbansal@uw.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Jennifer Tsing
Phone
206-616-5190
Email
jtsing@uw.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nisha Bansal, MD
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Chi-yuan Hsu, MD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chi-yuan Hsu
Phone
415-476-2173
Email
chi-yuan.hsu@ucsf.edu
Facility Name
University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nisha Bansal, MD

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

The Home Blood Pressure (BP) Trial

We'll reach out to this number within 24 hrs