What this study is
Simplified from ClinicalTrials.govTesting two blood pressure goals, below 120 or below 140 mmHg for the top number, to see whether a larger study comparing them is possible in adults 18 and older with end-stage kidney disease and high blood pressure who receive peritoneal dialysis. Participants are assigned by chance to one goal.
Read the original summary from ClinicalTrials.gov
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.
What's being tested
- Target systolic blood pressure <120 mmHg.
Intervention · OTHER
The target SBP <120 mmHg will be operationalized as SBP 100-119 mmHg in the intervention arm. For volume control, the patient's dry weight target will be adjusted downward and will be attempted to be achieved through greater PD ultrafiltration, dietary fluid/salt restriction, or diuretics. Once patients are deemed euvolemic based on the assessment of the treating nephrologist, antihypertensive medications will be added or adjusted in a standardized sequence: priority is given to angiotensin-converting enzyme inhibitors (ACE inhibitors) or angiotensin receptor blockers (ARBs) due to data about this class of agents being shown to better preserve residual kidney function. Other medications are recommended to be added as indicated to maintain SBP <120 mmHg in the interventional arm. If SBP were <100 mmHg at one visit or <105 mmHg at two consecutive visits, BP medications will be reduced to keep SBP in the range of 100 to 119 mmHg, to avoid hypotensive episodes.
- Target systolic blood pressure <140 mmHg
Intervention · OTHER
The target SBP <140 mmHg will be operationalized as SBP 130-139 mmHg. For volume control, the patient's dry weight target will be adjusted downward and will be attempted to be achieved through greater PD ultrafiltration, dietary fluid/salt restriction, or diuretics. Once patients are deemed euvolemic based on the assessment of the treating nephrologist, antihypertensive medications will be added or adjusted in a standardized sequence: priority is given to angiotensin-converting enzyme inhibitors (ACE inhibitors) or angiotensin receptor blockers (ARBs) due to data about this class of agents being shown to better preserve residual kidney function. Other medications are recommended to be added as indicated to maintain <140 mmHg in the control arm. If SBP were <130 mmHg at one visit or <135 mmHg at two consecutive visits, BP medications will be tapered/discontinued to keep SBP in the range of 130 to 139 mmHg.
Study details
- Sponsor
- University of California, San Francisco
- Conditions
- End Stage Kidney Disease (ESKD) · Hypertension (HTN) · Peritoneal Dialysis (PD)
- Enrolling
- 10 people
- Starts
- 2026-10-30
- Est. completion
- 2027-06
- Design
- Open-label, randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (3)
3 openContact for every open site
- Kashvi Gupta, MD, MPH · Contact734-546-4545kashvi.gupta@ucsf.edu
Satellite Healthcare - Daly City
San Francisco, California, United States
RecruitingZuckerberg San Francisco General Hospital
San Francisco, California, United States
Not yet recruitingSatellite Healthcare - San Francisco Geary
San Francisco, California, United States
Recruiting
Study team
Sponsor
University of California, San Francisco
Study ID STUDY00000009
Principal investigator
Chi-yuan Hsu, MD, MS
University of California, San Francisco
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.