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Completed

NCT Number: NCT05159999

The Home Blood Pressure (BP) Trial

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California San Francisco, San Francisco, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Dry weight target adjustment

Other

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

Anti-Hypertensive medications

Drug

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 outcomes

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

    Time frame: 10 months

    Test the effect of treating home SBP <140mmHg vs a pre-dialysis SBP <140mmHg on rates of IDH

Secondary outcomes

  1. Fatigue by SONG-HD Score

    Time frame: 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)

  2. Cramping

    Time frame: 10 months

    Test the effect of treating home SBP <140mmHg vs a pre-dialysis SBP <140mmHg on frequency of cramping

  3. Rates of hospitalizations for cardiovascular events and volume overload

    Time frame: 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

Other outcomes

  1. Separation of blood pressures

    Time frame: 2 months

    Determine whether the intervention is able to achieve a home systolic blood pressure <130mmHg in this optional study.

  2. Correlation between pre-dialysis and home SBP

    Time frame: 10 months

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

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Collaborators

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

Registry information

Acronym: Home-BP

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Dec 16, 2021
Registry last updated
Jul 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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