Cuffless 24-hour ambulatory blood pressure monitoring-guided antihypertensive titration in real-world clinical practice: a prospective non-randomized study

Abstract

Background Twenty-four-hour ambulatory blood pressure monitoring (ABPM) is the reference standard for diagnosing hypertension and assessing treatment response, but routine use remains limited by conventional cuff-based devices. We compared 6-month ambulatory blood pressure (BP) between cuffless 24-hour ABPM-guided titration and usual care in outpatient hypertension management. Methods We conducted a single-center, open-label, non-randomized prospective study of adults with uncontrolled hypertension between March and November 2025. Participants were assigned by the treating physician, without randomization, to CART BP pro-guided titration (CART BP arm, n = 67) or usual care (Control arm, n = 179). The primary endpoint was 24-hour mean systolic BP at 6 months, analyzed using analysis of covariance with 10 prespecified covariates. Sensitivity analyses addressed measured confounding, missing outcomes, and visit frequency. Results Among 162 participants with a valid 6-month ABPM recording, the adjusted between-group difference in 24-hour systolic BP was −7.35 mmHg (95% confidence interval [CI], −12.03 to −2.67 mmHg; P < 0.01), favoring the CART BP arm. Sensitivity analyses for measured confounding, missing outcomes, and visit frequency yielded similar estimates. In exploratory phenotype-specific comparisons, the controlled-BP phenotype was more prevalent in the CART BP arm (65.8% vs. 36.3%; P < 0.01), and masked hypertension was less prevalent (5.3% vs. 20.2%; P = 0.04). Adjusted office systolic BP differed by −3.14 mmHg (95% CI, −9.25 to 2.96; P = 0.31). Adverse events were more frequent per participant (20.0% vs. 8.1%; P = 0.02); exposure-adjusted incidence rate ratios were 1.78 (95% CI, 0.87 to 3.65) per participant-visit and 2.75 (95% CI, 1.35 to 5.61) per person-year. Conclusions In this non-randomized study, a care pathway incorporating cuffless 24-hour ABPM was associated with lower 24-hour ambulatory systolic BP at 6 months compared with usual care, whereas office systolic BP did not differ significantly between arms. Given the non-randomized design, these findings are hypothesis-generating and require confirmation in a randomized trial. Trial Registration ClinicalTrials.gov Identifier: NCT07454148