Treatment Hypertension to Recommended Levels in Old Patients
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Achievement of recommended target BP level
研究概览
简要总结
After checking the patient characteristics to the inclusion and exclusion criteria, and confirming the ability to complete the questionnaires provided by the study protocol, patients will be randomly assigned to 2 groups: a group with a higher target BP level (less than 135 mmHg) and a lower target BP level (less than 125 mmHg). Achievement of target BP levels will be assessed using a remote monitoring system. The study will identify factors that prevent achievement of target BP levels, as well as assess the efficacy, safety and tolerability of antihypertensive therapy (AHT).
详细描述
The study duration is 3 months. It is planned to include at least 60 patients in the study. Before any procedures related to the study, the patient must be provided with comprehensive information about the study product, possible risks associated with its use and / or participation in the study. The study participant must provide written consent to participate in the study. At the first face-to-face visit, informed voluntary consent will be obtained in both groups, a physical examination will be performed, including measuring blood pressure, heart rate, and an orthostatic test. Monitoring will be based on measurements of office blood pressure by a doctor at the stage of inclusion in the study, as well as by the patient himself during home blood pressure measurements daily for 3 months and after 3 months at a follow-up visit to the doctor. BP will be measured with an automatic/semiautomatic tonometer in a sitting position after at least 5 minutes of rest, twice on the right and left arms, then BP will be measured on the arm with the higher systolic BP level, first in a horizontal position, then the patient will be asked to stand up and BP will be measured 45 seconds, 3 and 6 minutes after moving to a vertical position. HR will be assessed with the patient in a sitting position, lying down and 45 seconds, 3 and 6 minutes after moving to orthostasis. For the orthostatic test, the results of BP measurements while lying down and 1, 3 and 6 minutes after moving to orthostasis will be used. Orthostatic hypotension will be diagnosed with a decrease in systolic BP by 20 mmHg or more or diastolic BP by 10 mmHg or more, or a decrease in both parameters. Patients will be taught the rules for measuring BP at home. Specialized questionnaires will be filled in, combined antihypertensive therapy will be prescribed according to clinical guidelines. Daily contact using remote access: blood pressure control during home measurement and remote monitoring in case of an episode of arterial hypotension, symptom assessment using an additional questionnaire in the chatbot, and therapy adjustment if necessary.
Main objective: During the implementation of an open randomized clinical trial using home blood pressure (BP) measurement data and a remote monitoring system (TeleMedBot) for the efficacy and safety of AHT therapy, to test the hypothesis that achieving lower recommended target BP levels will be no less safe than achieving higher recommended target BP levels in elderly and senile patients with hypertension.
Optimization of drug therapy will be carried out by the research physician throughout the study.
Weekly throughout the study, the patient will be contacted to assess the safety of drug therapy and decide on AHT optimization.
The patient will also have a chatbot installed on their electronic device. The patient will be trained to work with it and will be able to ask all the questions they are interested in related to its operation. The questionnaire will consist of 2 questions and will be sent twice a day at 12:00 and 21:00. It is recommended to fill it out every day. When signs of a decrease in blood pressure are detected, the patient will be asked to fill out an additional questionnaire on the tolerability of therapy and additional telephone contact will be established with them to determine further tactics.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women aged 65 years and older with hypertension previously diagnosed based on repeated measurements in a medical institution.
排除标准
- •Diagnosed dementia or severe cognitive impairment.
- •Inability to fill in questionnaires specified in the study protocol.
- •Inability to use automatic devices for recording blood pressure at home.
- •Inability to use electronic devices required for remote monitoring of home blood pressure measurements and patient well-being.
- •Presence of hemodynamically significant valvular heart defects.
- •Presence of severe renal impairment (eGFR <30 ml/min/1.73 m2) and/or increased blood creatinine levels to 221 μmol
- •Myocardial infarction or stroke within the previous 6 months.
- •Chronic heart failure with EF ≤ 40%.
研究组 & 干预措施
BP <135
Higher target BP group (less than 135 mmHg). Achievement of target BP, assessment of symptoms and frequency of hypotensive episodes will be assessed.
干预措施: TeleMedBot (Device)
BP <125
Higher target BP group (less than 125 mmHg). Achievement of target BP, assessment of symptoms and frequency of hypotensive episodes will be assessed.
干预措施: TeleMedBot (Device)
结局指标
主要结局
Achievement of recommended target BP level
时间窗: 1 month
Achievement of recommended target BP level
次要结局
- Assessment of the frequency of hypotensive episodes and the occurrence of hypotensive symptoms(3 months)