Effects of Remote Ischemic Conditioning on Blood Pressure in Older Patients With Hypertension

Обзор

The purpose of this study is to learn about effects of remote ischemic conditioning on blood pressure in older patients with essential hypertension.

Подробное описание

Current studies have shown that remote ischemic conditioning can improve vascular endothelial function and inhibit sympathetic nervous system activity. Thus it may provide some organ protection as well as anti-hypertensive effects. The purpose of this study is to learn about effects of remote ischemic conditioning on blood pressure in older patients with essential hypertension.

Вмешательства

• Процедура Remote ischemic conditioning
  Remote ischemic conditioning (RIC) is induced by 4 cycles of 5 min of upper limb ischemia followed by 5 min reperfusion. Limb ischemia was induced by the inflation of an automated cuff to the pressure rising by 20 mmHg from baseline systolic pressure. RIC will be conducted twice daily for 7 days.
• Процедура Sham remote ischemic conditioning
  Sham-RIC is performed in the same way as the treatment group except that the blood pressure cuff is inflated to 60 mmHg, which produces mild pressure sensations but has no blocking impact on blood flow.

Первичные конечные точки

• Mean systolic blood pressure [Срок оценки: 0-7 days]

Вторичные конечные точки (1)

• Mean diastolic blood pressure [Срок оценки: 0-7 days]

Критерии участия

Критерии включения

• 1\) Age ≥65 years and ≤85 years, regardless of gender;
• 2\) History of essential hypertension and clinical systolic blood pressure ≥ 140 mmHg, regardless of whether they are receiving antihypertensive medication;
• 3\) Willing to participate and sign the informed consent.

Критерии исключения

• 1\) Secondary hypertension;
• 2\) Clinical blood pressure ≥ 180/110 mmHg or 24-hour mean arterial pressure ≥ 170/100 mmHg;
• 3\) Severe organ dysfunction or failure;
• 4\) Severe hematologic disorders or significant coagulation abnormalities;
• 5\) History of atrial fibrillation or myocardial infarction within 6 months;
• 6\) Individuals who had contraindication of remote ischemic conditioning, such as severe soft tissue injury, fracture or vascular injury in the upper limb, acute or subacute venous thrombosis, arterial occlusive disease, subclavian steal syndrome, etc;
• 7\) Individuals who will or have received anticoagulant therapy with drugs such as dabigatran, rivaroxaban, warfarin, etc;
• 8\) Those who are participating in other clinical research or has participated in other clinical research or has participated in this study within 3 months prior to enrollment;
• 9\) Other conditions that the researchers think are not suitable for the project.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• First Hospital of Jilin University — Changchun

Идентификаторы

NCT: NCT05845905 · RICBP-HT

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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