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Guiding Optimal Blood Pressure Management in Peritoneal Dialysis Pilot Trial

a study on End Stage Renal Disease Kidney Disease High Blood Pressure Dialysis Chronic Kidney Disease

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCSF
Dates
study started
study ends around
Principal Investigator
by Chi-yuan Hsu, MD, MS (ucsf)
Headshot of Chi-yuan Hsu
Chi-yuan Hsu

Description

Summary

The GOAL-BP pilot study will help determine whether a study comparing two blood pressure goals can be carried out in adults with end-stage kidney disease and high blood pressure who receive peritoneal dialysis. The main questions it aims to answer are whether eligible patients can be recruited for the study.

Researchers will compare two goals for the top blood pressure number (systolic blood pressure): below 120 mmHg versus below 140 mmHg.This pilot study will help plan a larger trial in the future.

Participants will:

  • Be assigned by chance to one of the two blood pressure goals.
  • Have their blood pressure measured at clinic visits about every two weeks.
  • Work with their kidney doctor on recommended changes to fluid management, peritoneal dialysis treatment, or blood pressure medicines to reach their assigned goal.
  • Be part of the study for about four and a half months.

Details

Peritoneal dialysis (PD) use among patients with end-stage kidney disease (ESKD) has increased substantially over the last decade. Yet there are no randomized clinical trials evaluating blood pressure (BP) targets in patients receiving PD.

GOAL-BP is a pilot study that will evaluate the feasibility of enrolling patients receiving PD to two systolic blood pressure targets (SBP): <120mmHg vs. <140 mmHg.

BP management will be guided by standardized clinic measurements. The study team will make recommendations to the treating nephrologist to achieve the goal SBP using a stepwise approach that addresses volume status before recommending changes to antihypertensive medications. The treating nephrologist will make the final decision about any changes to clinical care.

Keywords

End Stage Kidney Disease (ESKD), Hypertension (HTN), Peritoneal Dialysis (PD), Target blood pressure, Peritoneal dialysis, End stage kidney disease, Hypertension, Chronic Kidney Failure, Target systolic blood pressure <120 mmHg., Target systolic blood pressure <140 mmHg

Eligibility

You can join if…

Open to people ages 18 years and up

  • Age ≥ 18 years.
  • Undergoing regular PD for treatment of ESKD.
  • On PD for ≥ 4 months. (We do not plan to enroll patients within the first 3 months of PD initiation because there can be large fluctuations in volume status and BP readings before patient coming into more of a steady state. We then require participants to have at least 1 month of BP data to allow calculation of an average pre-enrollment BP for screening for study entry.)
  • Diagnosis of HTN defined as being on antihypertensive medications or having routine clinic SBP ≥ 140 mmHg averaged over prior one month to screening.
  • Able to measure brachial BP.

You CAN'T join if...

  • Planned transplant or HD transition < 4.5 months (the duration of study).
  • Estimated life expectancy < 4.5 months (also determined by asking the treating nephrologist).
  • Participation in another clinical trial that may affect BP management.
  • Pregnancy, anticipated pregnancy, or breastfeeding as this will limit the use of certain antihypertension medications in the study and pose additional risks to the patient and many pregnant patients are transitioned over to hemodialysis.
  • Incarceration or institutionalized living which may prohibit measurement of home BP.
  • Presence of a condition or abnormality that, in the opinion of the study team or treating nephrologist, would compromise the safety of the patient or the quality of the data.

Locations

  • Zuckerberg San Francisco General Hospital
    San Francisco California 94110 United States
  • Satellite Healthcare - San Francisco Geary
    San Francisco California 94118 United States
  • Satellite Healthcare - Daly City
    San Francisco California 94014 United States

Lead Scientist at University of California Health

  • Chi-yuan Hsu, MD, MS (ucsf)
    Dr. Hsu has been Chief of the Division of Nephrology at UCSF Health since 2007. He currently holds the Dr. Robert W. Schrier Distinguished Professorship in Nephrology. His research spans acute, chronic and end-stage kidney disease and includes both observational studies and clinical trials.

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT07910773
Study Type
Interventional
Participants
Expecting 10 study participants
Last Updated