ACTIVE_NOT_RECRUITING

The Home Blood Pressure (BP) Trial

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

The Home Blood Pressure (BP) Trial

Quick Facts

Study Start:2022-02-02
Study Completion:2026-04-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05159999

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Aged 18 years or older
  2. * Undergoing in-center, thrice weekly hemodialysis for treatment of end stage renal disease (ESRD)
  3. * Greater than 3 months since initiation of dialysis
  4. * No anticipated change to peritoneal dialysis or kidney transplant within 10 months
  5. * Life expectancy greater than 10 months
  6. * Hypertension (defined as mean pre-dialysis SBP \> 140 mmHg over prior 2 weeks or taking BP medications)
  7. * 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)
  8. * No condition that the primary nephrologist or PIs feel precludes participation
  1. * Incarcerated or institutionalized (prohibits home blood pressure measurement)
  2. * Participating in another intervention study that may affect blood pressure
  3. * 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

Principal Investigator

Nisha Bansal, MD
PRINCIPAL_INVESTIGATOR
University of Washington
Chi-yuan Hsu, MD
PRINCIPAL_INVESTIGATOR
University of California, San Francisco

Study Locations (Sites)

University of California San Francisco
San Francisco, California, 94143
United States
University of Washington
Seattle, Washington, 98104
United States

Collaborators and Investigators

Sponsor: University of Washington

  • Nisha Bansal, MD, PRINCIPAL_INVESTIGATOR, University of Washington
  • Chi-yuan Hsu, MD, PRINCIPAL_INVESTIGATOR, University of California, San Francisco

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-02-02
Study Completion Date2026-04-30

Study Record Updates

Study Start Date2022-02-02
Study Completion Date2026-04-30

Terms related to this study

Keywords Provided by Researchers

  • Blood pressure, dialysis

Additional Relevant MeSH Terms

  • End Stage Renal Disease on Dialysis