Effects of Remote Ischemic Conditioning on Blood Pressure in Older Patients With Hypertension

Study Overview
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Brief Summary
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The purpose of this study is to learn about effects of remote ischemic conditioning on blood pressure in older patients with essential hypertension.

Detailed Description
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Current studies have shown that remote ischemic conditioning can improve vascular endothelial function and inhibit sympathetic nervous system activity. Thus it may provide some organ protection as well as anti-hypertensive effects. The purpose of this study is to learn about effects of remote ischemic conditioning on blood pressure in older patients with essential hypertension.

Official Title
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Effects of Remote Ischemic Conditioning on Blood Pressure in Older Patients With 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: 1) Age ≥65 years and ≤85 years, regardless of gender; 2) History of essential hypertension and clinical systolic blood pressure ≥ 140 mmHg, regardless of whether they are receiving antihypertensive medication; 3) Willing to participate and sign the informed consent. Exclusion Criteria: 1) Secondary hypertension; 2) Clinical blood pressure ≥ 180/110 mmHg or 24-hour mean arterial pressure ≥ 170/100 mmHg; 3) Severe organ dysfunction or failure; 4) Severe hematologic disorders or significant coagulation abnormalities; 5) History of atrial fibrillation or myocardial infarction within 6 months; 6) 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; 7) Individuals who will or have received anticoagulant therapy with drugs such as dabigatran, rivaroxaban, warfarin, etc; 8) 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; 9) Other conditions that the researchers think are not suitable for the project.

Ages Eligible for Study
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Minimum Age: 65 Years
Maximum Age: 85 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 the inflation of an automated cuff to the pressure rising by 20 mmHg from baseline systolic pressure. RIC will be conducted twice daily for 7 days.<br>|
| Placebo Comparator: Sham RIC group<br>Patients are treated with sham remote ischemic conditioning (sham-RIC). | Procedure: Sham remote ischemic conditioning<br>* Sham-RIC is performed in the same way as the treatment group except that the blood pressure cuff is inflated to 60 mmHg, which produces mild pressure sensations but has no blocking impact on blood flow.<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 value of systolic blood pressure during RIC/sham-RIC between two groups. | 0-7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean diastolic blood pressure | Difference in mean value of diastolic blood pressure during RIC/sham-RIC between two groups. | 0-7 days |