Safety and Efficacy of Remote Ischemic Conditioning Treatment for Community-based Essential Hypertension

Официальное название

Safety and Efficacy of Remote Ischemic Conditioning Treatment for Community-based Essential Hypertension: a Randomized, Parallel-controlled Clinical Trial

Обзор

The purpose of this study is to explore the efficacy and safety of remote ischemic conditioning for essential hypertension in the community population.

Подробное описание

At present, stroke has become the leading cause of death in China, with hypertension being the primary risk factor and one of the controllable risk factors. Current studies have shown that remote ischemic conditioning can improve vascular endothelial function, inhibit sympathetic nervous system activity and regulate immune and inflammatory reactions. Thus it may exert anti-hypertensive effects through multiple mechanisms. The purpose of this study is to investigate the efficacy and safety of remote ischemic conditioning for essential hypertension in the community population.

Вмешательства

• Устройство Patients are treated with previous antihypertensive treatment plus 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 inflation of a blood pressure cuff to 200 mmHg.
• Другое Previous antihypertensive treatment
  Patients are only treated with previous antihypertensive treatment.

Первичные конечные точки

• Changes of mean systolic blood pressure [Срок оценки: 12-14 days]

Вторичные конечные точки (4)

• Mean systolic blood pressure level [Срок оценки: 12-14 days]
• Changes of mean diastolic blood pressure [Срок оценки: 12-14 days]
• Mean diastolic blood pressure level [Срок оценки: 12-14 days]
• Blood pressure target achievement rate [Срок оценки: 14 days]

Критерии участия

Критерии включения

• Age≥30 years, ≤ 75 years, regardless of sex;
• Patients with a history of essential hypertension and systolic blood pressure (SBP) ≥140 mmHg in three blood pressure measurements performed on separate days within 3 days prior to enrollment.
• Signed and dated informed consent is obtained.

Критерии исключения

• Blood pressure ≥ 180/110mmHg;
• Planned adjustment of antihypertensive drugs within the next 3 weeks;
• Severe hematologic disorders or significant coagulation abnormalities;
• 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;
• Pregnant or lactating women;
• Severe hepatic and renal dysfunction;
• Patients being enrolled or having been enrolled in another clinical trial within the 3 months prior to this clinical trial;
• Patients unsuitable for enrollment in the clinical trial according to the investigator's discretion.

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

Простое слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• First Hospital of Jilin University — Changchun

Идентификаторы

NCT: NCT03945305 · SERIC-EH

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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