Guiding hypertension management using different blood pressure monitoring strategies (GYMNs study): comparison of three different blood pressure measurement methods

Abstract Background Home blood pressure (HBP) monitoring and unattended automated BP (uAOBP) measurement are recommended by current guidelines for managing hypertensive patients. However, peripheral BP measurements cannot directly replace central BP assessments. Furthermore, the comparative efficacy and safety of BP-guided strategies employing these devices have not been systematically evaluated. Methods and Design Patients aged 20–90 years with either uncontrolled or newly diagnosed hypertension will be recruited from outpatient clinics and randomly allocated into one of 3 treatment arms—BP, uAOBP, or central BP (CBP)-guided treatment. At each scheduled clinic visit, BP will be measured using all three methods, ensuring that readings from each method are consistently available. Patients and physicians will remain blinded to the assigned intervention, as BP values will be presented in a standardized report format. All 3 BP-guided strategies will target a systolic BP (SBP) of 130 mmHg. The primary outcome is the change in 24-hour mean ambulatory SBP at three months. Key secondary outcomes include the proportion of participants achieving target BP at three months and the reduction in left ventricular mass over 12 months. Result A total of 239 patients with a mean age of 59.49 years; 125 (52.3%) were male. Following randomization, 78 patients were assigned to the HBP group, 81 to the uAOBP group, and 80 to the CBP group. For the primary endpoint, changes in SBP measured by ABPM at three months demonstrated that the HBP group achieved statistical non-inferiority compared to both the uAOBP and CBP groups (p = 0.0346 and p = 0.0135, respectively). Regarding key secondary endpoints, changes in SBP measured by ABPM at 12 months also showed statistical non-inferiority of the HBP group compared to the uAOBP and CBP groups (p = 0.0266 and p = 0.0019, respectively). In terms of left ventricular mass, all three groups (HBP, uAOBP, and CBP) exhibited increases over the one-year period, with mean increases of 11.2 g, 7.31 g, and 9.99 g, respectively. The HBP group demonstrated statistical non-inferiority compared to both the uAOBP and CBP groups (p = 0.0468 and p = 0.0460, respectively). Conclusions In hypertension management, HBP demonstrated comparable effectiveness in BP control when compared to uAOBP and CBP, at both 3 M and 12 M.