University of California, San Francisco
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.
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…
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…
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.
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.