JMIR Publications

ABSTRACT

Background:

Current guidelines recommend ambulatory blood pressure (BP) monitoring (ABPM) to diagnose hypertension and ensure satisfactory therapeutic BP control.

Objective:

To describe the objectives, design, and procedures of the Sleep-Time Blood Pressure and Chronic Kidney Disease Progression (Sleep-BP-CKD) Study that examines as predictors of a composite study endpoint of renal and CVD events: (1) ambulatory BP monitoring (ABPM)-derived parameters versus wake-time office BP measurements (OBPM) and (2) in a subgroup of volunteer enrollees, home BP monitoring (HBPM)-derived parameters using the Omron NightView device. Additionally, it assesses: (3) accuracy of the NightView HBPM built-in sleep-time sampling scheme and alternative ABPM-contrived sampling schemes in estimating the asleep BP mean and classifying dipping patterns, and (4) patient tolerance and acceptability of periodic 48-h ABPM and 7-day HBPM.

Methods:

Individuals ≥18 years of age with moderate to severe decreased estimated glomerular filtration rate (eGFR), CKD stage G3b and G4, respectively, will be eligible to enroll. At baseline and every 3 months during follow-up, OBPM, blood and urine sample analytes, and information on sociodemographic and anthropometric characteristics, lifestyle behaviors, medical history, and antihypertensive and other pharmacotherapy will be collected/updated. Additionally, 48-h ABPM, with sleep onset and offset times recorded in a sleep diary, will be conducted to derive, among other clinically relevant parameters, the 48-h, awake, and asleep means for systolic and diastolic BP (SBP, DBP), heart rate, and their respective sleep-time relative decline indices. In a subgroup of volunter enrolles, 7 days of HBPM also will be collected monthly. Enrollees are to be followed for ≥1 year until exhibiting a CKD or CVD study endpoint or study termination. Individual renal study events (30% decrease from baseline in eGFR, 30% increase in albuminuria, or progression to ESKD) and CVD events (myocardial infarction, surgical coronary revascularization, heart failure, peripheral artery disease, ischemic stroke, hemorrhagic stroke and fatal CVD) will be documented by a committee blinded to patient profiles and data analyses. Participants experiencing a study endpoint will be eligible to re-enroll for additional ≥1 year follow-up.

Results:

The study was registered on Clinicaltrials.gov and European Union Drug Regulating Authorities Clinical Trials Database prior to enrolling patients. Data analyses will follow a pre-registered plan. A total of 180 valid baseline profiles were collected from enrollees fulfilling all study eligibility criteria.

Conclusions:

This protocol outlines a study design that uniquely incorporates repeated OBPM and ABPM, plus blood, urine, and other medical assessments during follow-up to capture the dynamic clinical profile of advanced-stage CKD patients and determine the ABPM vs. OBPM parameters most predictive of CKD progression and CVD events. It is anticipated this study will substantiate the clinical relevance of ABPM to better inform the clinical care of CKD patients. Clinical Trial: Clinicaltrials.gov (NCT05189418) European Union Drug Regulating Authorities Clinical Trials Database (EudraCT: 2021-002585-41)