Intensive Home Blood Pressure Lowering in Advanced Chronic Kidney Disease: A Pilot Randomized Controlled Trial Protocol

Background: Suboptimal blood pressure (BP) control is known to be common in patients with advanced chronic kidney disease (CKD) and may contribute to elevated risk of cardiovascular (CV) morbidity and mortality. Most trials have tested alternative clinic-based BP targets, even though home and ambulatory BPs have been shown to be more strongly associated with outcomes of interest. We designed a pilot randomized controlled trial to examine whether intensive lowering of systolic blood pressure (SBP) to a target < 120 mmHg with remote home BP monitoring is safe and feasible for patients with advanced CKD as they transition to end-stage kidney disease (ESKD). Methods: Patients with stage 4 or 5 CKD (estimated glomerular filtration rate ≤ 30 mL/min/1.73 m 2 ) with hypertension, defined as receipt of at least one antihypertensive agent or a clinic SBP> 140 mmHg, will be randomly assigned to either a home SBP target of < 120 mmHg (intervention group) or 130– 140 mmHg (control group). Antihypertensive medications are titrated as needed to achieve target SBP levels over the first 4 months of the trial, and target SBPs are maintained thereafter. After month 12, biannual visits are conducted until study closeout. Participants are followed closely for safety and feasibility outcomes including screening:enrollment ratio, rates of hyperkalemia, hospitalizations or emergency room visits, and achieved separation in home BP readings between the two groups at month 8. Discussion: This protocol outlines the design of a pilot trial to examine the safety and feasibility of an intensive home BP lowering intervention in patients with advanced CKD through remote home BP monitoring. This pilot study will provide the necessary data to inform the planning of a full-scale trial comparing strict versus usual BP control in patients with advanced CKD, including those with diabetes. Knowledge of the optimal BP targets in advanced CKD will better inform the approach to CV and kidney risk reduction as patients transition to ESKD. Trial Registration: ClinicalTrials.gov identifier NCT02975505. Registered November 29, 2016. https://clinicaltrials.gov/ct2/show/NCT02975505?term=NCT02975505&draw=2&rank=1 .