Long-term of Remote Ischemic Preconditioning and Mindfulness in Patients With Mild Hypertension

Обзор

According to the latest survey data of China hypertension annual meeting, there are about 300 million patients with hypertension in China, with 10 million new cases of hypertension each year, and there is an obvious trend of younger people. In particular, young and middle-aged people are in a state of mild hypertension for a long time, which causes great pressure on health and medical treatment. At present, the main clinical measures for mild hypertension are to change their eating habits, quit smoking and alcohol, exercise and other lifestyle changes, as well as drug control. For most patients with mild hypertension, drug control is not the best choice. It has been reported that remote ischemic preconditioning (RIPC) may play an effective role in reducing blood pressure .The purpose of this study was to investigate the extent of long-term application of RIPC to reduce blood pressure in patients with mild hypertension.

Подробное описание

A total of 200 patients with mild hypertension were enrolled in this study, using the method of open label and parallel grouping; 100 cases in the experimental group and 100 cases in the control group, The experimental group was divided into life intervention + drug group and life intervention + ripc group, with 50 patients in each group. The results of 24-hour ambulatory blood pressure monitoring (ABPM) of the three groups were observed before and 3 months after use, including HR, pulse pressure, 24-hour systolic blood pressure, 24-hour diastolic blood pressure, daytime systolic blood pressure, daytime diastolic blood pressure, nighttime systolic blood pressure and nighttime diastolic blood pressure. The changes of renalase, catecholamine, renin, angiotensin - Ⅱ, aldosterone, RhoA kinase, no, adenosine and bradykinin were observed.

Вмешательства

• Устройство CRIC
  Remote Ischemic Conditioning (CRIC): Twice daily for 12 weeks using an automated cuff device. Each 30-minute session consisted of 3 cycles of 6 min inflation (pressure individualized: resting SBP-based increments of +40/+30/+20 mmHg depending on baseline SBP level) followed by 4 min deflation (0 mmHg).
• Поведенческое MFT
  Sham CRIC: Identical schedule and device; each cycle used fixed 5 min inflation at 60 mmHg (non-ischemic) followed by 5 min deflation.
• Другое sham CRIC
  Sham CRIC: Identical schedule and device; each cycle used fixed 5 min inflation at 60 mmHg (non-ischemic) followed by 5 min deflation.
• Другое sham MFT
  Sham MFT: Twice daily equivalent-duration audio of looped neutral nature sounds (ocean waves, flowing water, birdsong) without mindfulness instructions.

Первичные конечные точки

• Mean systolic blood pressure [Срок оценки: 3 months]
• Mean diastolic blood pressure [Срок оценки: 3 months]

Вторичные конечные точки (5)

• Concentration of Renalase [Срок оценки: 3 months]
• Concentration of catecholamine [Срок оценки: 3 months]
• Concentration of adenosine [Срок оценки: 3 months]
• Concentration of bradykinin [Срок оценки: 3 months]
• Concentration of renin [Срок оценки: 3 months]

Критерии участия

Критерии включения

• Diagnosed patients with mild hypertension (SBP: 140\~159mmHg; DBP: 90\~99mmHg)

Критерии исключения

• Cannot tolerate RIPC
• Non-essential hypertension
• patients who have uncontrolled severe arrhythmia, diabetes, electrolyte disturbance
• patients who have severe organic diseases such acute myocardial infarction, cardiac insufficiency, abnormal renal function, etc.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Факторный дизайн

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Fuwai central China Cardiovascular hospital — Чжэнчжоу

Публикации

• Jones H, Hopkins N, Bailey TG, Green DJ, Cable NT, Thijssen DH. Seven-day remote ischemic preconditioning improves local and systemic endothelial function and microcirculation in healthy humans. Am J Hypertens. 2014 Jul;27(7):918-25. doi: 10.1093/ajh/hpu004. Epub 2014 Mar 13. PMID 24627443
• Moro L, Pedone C, Mondi A, Nunziata E, Antonelli Incalzi R. Effect of local and remote ischemic preconditioning on endothelial function in young people and healthy or hypertensive elderly people. Atherosclerosis. 2011 Dec;219(2):750-2. doi: 10.1016/j.atherosclerosis.2011.08.046. Epub 2011 Sep 7. PMID 21945497

Идентификаторы

NCT: NCT04753840 · HenanICE202103

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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