Evaluation of the safety of achieving recommended blood pressure targets in elderly patients: protocol of a randomized, open‑label, prospective, pragmatic study THReshOld (Treatment of Hypertension to Recommended blood pressure in Old patients with hypertension)

Objective — the main objective of the study is to test the hypothesis that achieving lower recommended target levels (LRT) of blood pressure (BP) in elderly and senile patients with arterial hypertension (HTN) will be no less safe than achieving higher recommended target levels (HRT) of BP in elderly and senile patients with HTN, which will be assessed using home BP measurement data and a remote monitoring system for the effectiveness and safety of antihypertensive therapy. Design and methods. The study is expected to include 60 patients aged 65 years and older, who will be randomly assigned to the LRT or HRT BP group with the achievement of recommended target levels of SBP (according to home BP measurement data) of less than 125 or less than 135 mmHg. The effectiveness of the intervention will be assessed by the following indicators: the frequency of episodes of arterial hypotension (SBP less than 100 mmHg) with or without clinical manifestations; frequency of fainting or pre-syncope; frequency of falls in general and traumatic falls; assessment using the AHT tolerability scale (scale developed by Duarte-Silva D. et al., 2014); assessment of quality of life using the disease- specific Quality of Life Questionnaire on Hypertension scale; duration of the period during which SBP will be in the therapeutic range as a percentage of the total observation period. In addition, it is supposed to assess the indicators of frailty and indicators of cognitive functions. The analysis of the obtained data will be performed using the Win Ratio method in a hierarchical order. Expected results. The study will provide data on the possibilities of remote monitoring with the selection of AHT in individuals aged 65 years and older in order to achieve target BP levels, as well as information on the tolerability of AHT when it is selected in order to achieve lower recommended BP levels in such patients.

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