Safety and Feasibility of Remote Ischemic Conditioning on Prehypertension and Early-stage Hypertension

Study Overview
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Brief Summary
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Nowadays, the incidence of stroke in China has reached 1.6‰, and this disease has become a primary cause of death in China. One of its major risk factors is hypertension. As shown in the researches, the risk of stroke grows remarkably when the blood pressure increases and there exists a log-linear relationship between them. Systolic pressure and diastolic pressure relate to the risk of stroke independently. Systolic pressure decreasing 10mmHg will reduce the stroke risk by 31% and a decrease of 1 3mmHg will reduce the stroke risk by20 30%. As to diastolic pressure, a 5mmHg decrease will reduce the stroke risk by 34% and a 10mmHg decrease will reduce the stroke risk by 56%.In addition, patients with isolated systolic hypertension (SPB≥160mmHg, DPB≤90mmHg) or critical isolated systolic hypertension (SPB=140 159mmHg, DPB< 90mmHg) will suffer a higher risk of stroke than people with normal blood pressure. The ACC has already revised its Hypertension ManagementGuidelines of the standard of diagnosis for hypertension and the timing of starting medical treatment in hypertensive patients. Because more and more researches shown that people with blood pressure between 120-139/80-89mmHg have higher risk of ASCVSD compared to those with blood pressure lower than120/80mmHg; However, in China, the diagnostic criteria for hypertension has not been revised yet. Therefore, we still have a blind spot in treating such patients who suffer from borderline systolic hypertension at 130 140 mmHg of blood-pressure with or without ASCVD or those with the first stage hypertension but refusing to take anti-hypertension drugs. What is more, most of them are middle-aged adults, once they have a stroke, it would lead to terrible and costly consequences to both their family and society. Thus, it is necessary to explore new non-pharmacological methods to control blood pressure for reducing the risk of stroke

Official Title
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Safety and Feasibility of Remote Ischemic Conditioning on Prehypertension and Early-Stage Hypertension

Conditions
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Prehypertension, Remote Ischemic Conditioning, Early Stage Hypertension

Intervention / Treatment
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* Device: remote ischemic conditioning


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: systolic blood pressure between 160 and 125 mmHg or diastolic blood pressure between 80 and 100 mmHg age≥18 essential hypertension patient did not take anti-hypertensive medicine regularly Exclusion Criteria: patients with severe uncontrolled diabetes contraindication for remote ischemic preconditioning life expectancy less than 1 year patients with atrial fibrillation or other kind of arrhythmia unwilling to be followed up or poor compliance.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: remote ischemic conditioning arm<br>Device: remote ischemic conditioningRIC is a physical strategy performed by an electric auto-control device with cuffs placed on unilateral arms and inflated to 200 mmHg for 5-min followed by deflation for 5-min, the procedures are performed repeatedly for 5 times# two times per day. The duration of the treatment is 30+/-2days. Other Names:• RICDevice: ambulatory blood pressure monitoring diagnostic technique for measuring blood pressure in daily life by means of automatic intermittent timing. Because ABPM has overcome the limitations of clinic blood pressure measurement, observation error and white coat effect, it can objectively reflect the actual level and fluctuation of blood pressure. Each patient of the two arms will use ABPM measure blood pressure before and after RIC or sham RIC treatment | Device: remote ischemic conditioning<br>* RIC is a physical strategy performed by an electric auto-control device with cuffs placed on unilateral arms and inflated to 200 mmHg for 5-min followed by deflation for 5-min, the procedures are performed repeatedly for 5 times# two times per day. The duration of the treatment is 4 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| tolerability and feasibility of remote ischemic conditioning on hypertension | there are 56 treatments in totall during 4weeks， the percentage of the completement of each treatment would be used to mearure the tolerance. | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| safety of remote ischemic conditioning on hypertension | all the adverse effect would be recorded and the percetage of adverse effect happened in the group would be used to measure the safety. | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hypertension, remote ischemic conditioning