Efficacy and Safety of Remote Ischemic Conditioning in the Treatment of Essential Hypertension (RICBP-EH)

Study Overview
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Brief Summary
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The purpose of this study is to determine the efficacy and safety of remote ischemic conditioning in the treatment of essential hypertension.

Detailed Description
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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 on blood pressure patients with essential hypertension.

Official Title
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Efficacy and Safety of Remote Ischemic Conditioning in the Treatment of Essential Hypertension

Conditions
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Essential Hypertension

Intervention / Treatment
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* Procedure: Remote ischemic conditioning
* Procedure: Sham remote ischemic conditioning


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age≥18 years, regardless of sex; Patients with systolic blood pressure ≥140mmHg with or without taking oral antihypertensive drugs Signed and dated informed consent is obtained Exclusion Criteria: Secondary hypertension; Clinical blood pressure ≥ 180/110 mmHg or 24-hour mean arterial pressure ≥ 170/100 mmHg; Severe organ dysfunction or failure; Severe hematologic disorders or significant coagulation abnormalities; History of atrial fibrillation or myocardial infarction within 6 months; 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; Individuals who will or have received anticoagulant therapy with drugs such as dabigatran, rivaroxaban, warfarin, etc; ; Pregnant or lactating women; 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; Other conditions that the researchers think are not suitable for the project.

Ages Eligible for Study
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Minimum Age: 18 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: RIC group<br>Patients are treated with remote ischemic conditioning (RIC). | Procedure: Remote ischemic conditioning<br>* 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 mm Hg.<br>|
| Sham Comparator: Sham RIC group<br>Patients are treated with sham remote ischemic conditioning (sham-RIC). | Procedure: Sham remote ischemic conditioning<br>* Sham-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 60 mm Hg.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean systolic blood pressure | Difference in mean systolic blood pressure during RIC/sham-RIC between two groups. | 1-7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean diastolic blood pressure | Difference in mean diastolic blood pressure during RIC/sham-RIC between two groups. | 1-7 days |