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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Long-term of Remote Ischemic Preconditioning in Patients With Mild Hypertension

Conditions
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Hypertension

Intervention / Treatment
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* Other: Antihypertensive drugs
* Other: remote ischemic preconditioning（RIPC）
* Behavioral: lifestyle intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosed patients with mild hypertension (SBP: 140 159mmHg; DBP: 90 99mmHg) Exclusion Criteria: 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.

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental A: Drug group+lifestyle intervention<br>Experimental group A used only one antihypertensive drug (ACEI / ARB, beta blocker, calcium channel blocker, diuretic, etc.) plus lifestyle intervention to control blood pressure. | Other: Antihypertensive drugs<br>* One of ACEI / ARB, beta blocker, calcium channel blocker, diuretic<br>Behavioral: lifestyle intervention<br>* Such as changing dietary habits, smoking cessation and alcohol restriction, exercise and so on.<br>|
| Experimental: Experimental B: RIPC group+lifestyle intervention<br>The experimental group B received ripc treatment of upper limbs every day plus lifestyle intervention until the end of the follow-up. The treatment time was 40 minutes per day, 10 minutes as a cycle (cuff inflated to 200 mmHg and maintained for 5 minutes, then deflated for 5 minutes to start the next cycle), a total of 4 cycles. | Other: remote ischemic preconditioning（RIPC）<br>* 40 minutes per day, 10 minutes as a cycle (cuff inflated to 200 mmHg and maintained for 5 minutes, then deflated for 5 minutes to start the next cycle)， a total of 4 cycles.<br>Behavioral: lifestyle intervention<br>* Such as changing dietary habits, smoking cessation and alcohol restriction, exercise and so on.<br>|
| Other: Experimental c: lifestyle intervention<br>The control group take lifestyle intervention to control blood pressure, such as changing dietary habits, smoking cessation and alcohol restriction, exercise and so on. | Behavioral: lifestyle intervention<br>* Such as changing dietary habits, smoking cessation and alcohol restriction, exercise and so on.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean systolic blood pressure | 24-hour Mean systolic blood pressure measured by Ambulatory blood pressure monitoring | 3 months | 
| Mean diastolic blood pressure | 24-hour Mean diastolic blood pressure measured by Ambulatory blood pressure monitoring | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Concentration of Renalase | blood renalase concentration | 3 months | 
| Concentration of catecholamine | Blood catecholamine concentration | 3 months | 
| Concentration of adenosine | blood adenosine concentration | 3 months | 
| Concentration of bradykinin | blood bradykinin concentration | 3 months | 
| Concentration of renin | blood renin concentration | 3 months |