Guiding Optimal Blood Pressure in Peritoneal Dialysis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

GOAL-BP is a randomized pilot study to see if adults on peritoneal dialysis with hypertension can be recruited and managed to two different systolic BP targets. Participants are randomly assigned to aim for SBP <120 mmHg or SBP <140 mmHg, with clinic BP checks every two weeks and adjustments to fluid management, dialysis, or medications as guided by the study team. The treating nephrologist makes final care decisions, following a stepwise approach centered on volume status before medicines changes. The study lasts about four-and-a-half months and assesses feasibility for a larger future trial.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Where it's running

• Satellite Healthcare - Daly City
  San Francisco, California, United States Recruiting
• Satellite Healthcare - San Francisco Geary
  San Francisco, California, United States Recruiting
• Zuckerberg San Francisco General Hospital
  San Francisco, California, United States Not yet recruiting

Study contacts

• Principal investigator: Chi-yuan Hsu, MD, MS — University of California, San Francisco
• Study coordinator: Kashvi Gupta, MD, MPH
• Email: Kashvi.Gupta@ucsf.edu
• Phone: 734-546-4545

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.