Telemedical care system for the treatment of arterial hypertension using recommendation algorithms to support diagnostic and therapeutic decisions—study protocol for a single-center, randomized, controlled, open-label SOT-ART-HT trial

Arterial hypertension is a global issue and achieving the blood pressure control is a challenge. It has been suggested that telemonitoring benefits these patients but there is a lack of research evaluating tools to assist doctors in caring for patients with arterial hypertension. Herein, we detail a protocol for a single-center, randomized, open-label study with a control group to develop a blood pressure monitoring system with a built-in algorithm supporting the physician's decisions. Two hundred patients aged 18–80 with a confirmed diagnosis of arterial hypertension and uncontrolled blood pressure during the screening visit will be recruited for the study. Patients with suspected or diagnosed secondary hypertension and pregnant/breast-feeding women will be excluded. In the initial study phase, a system will be developed for remote blood pressure monitoring, recording measurements, and detecting situations requiring medical assessment and potential intervention to identify patients needing urgent medical attention through innovative analysis of blood pressure measurements and co-morbidity data. Next, telemetric and algorithm-supported care will be compared to the standard care of hypertensive patients. Patients will be randomized 1:1 to each group and be observed for 6 months. Pharmacotherapy will be modified, office blood pressure, home blood pressure, and 24-h ambulatory blood pressure will be measured, and the presence of organ complications will be checked during visits. The primary endpoints include the time from study enrollment to the day of achieving blood pressure control and achieving blood pressure control within 6 months. Secondary endpoints involve some other parameters of blood pressure control and the costs analyses. The results are expected after 2026 and are anticipated to increase patient-to-physician ratios, allow the remote identification of urgent cases, reduce outpatient appointments, and achieve faster blood pressure control through telemetric observation with the algorithm compared to standard care. Clinical Trials NCT06722625, December 6, 2024.