Remote Ischemic Conditioning for the Treatment of Resistant Hypertension

Study Overview
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Brief Summary
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This study aims to explore the efficacy and safety of remote ischemia adaptation for the treatment of resistant hypertension.

Detailed Description
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Resistant hypertension is defined as a blood pressure of 140/90 mmHg or higher despite adherence to at least three antihypertensive drugs (including one diuretic), accounting for 20% to 30% of patients with hypertension. Compared with patients with well-controlled blood pressure, the cardiovascular risk of resistant hypertension is increased by about 50%. Limb remote ischemic conditioning (LRIC) triggers endogenous protective effects through transient and repeated ischemia in the limb to protect remote tissues and organs. The mechanisms of LRIC involve the regulation of the autonomic nervous system, the release of humoral factors, improvement of vascular endothelial function, and modulation of immune/inflammatory responses, which can antagonize the pathogenesis of hypertension through multiple pathways to lead to a drop in BP theoretically. This theory has been preliminarily confirmed by several small sample-size studies in non-resistant hypertension. This study aims to explore the efficacy and safety of remote ischemia adaptation for the treatment of resistant hypertension.

Official Title
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Efficacy and Safety of Remote Ischemic Conditioning for the Treatment of Resistant Hypertension: a Pilot Study

Conditions
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Resistant Hypertension

Intervention / Treatment
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* Device: RIC
* Device: Sham-RIC


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged 30 80 years old; Taking ≥ 3 antihypertensive drugs (including one diuretic) for more than 4 weeks regularly; Office blood pressure ≥ 140/90mmhg, and 24 h average blood pressure ≥ 130/80 mmHg; Willing to participate in the study, follow the study protocol, and provide informed consent. Exclusion Criteria: Secondary hypertension; eGFR<45ml/min/1.73m2； Office blood pressure ≥180/110 mmHg, and 24 h average blood pressure ≥ 170/100 mmHg； Hypertensive crisis occurred within 3 months; Type 1 diabetes; Cardiovascular events occurred within 3 months; Atrial fibrillation; Presence of any severe disease that adversely affects the subject or study; Patients with contraindication for remote ischemic conditioning, such as vascular injury, soft tissue injury, orthopedic injury, or arm infection; Pregnancy, lactation, or planned pregnancy; Patients not suitable for this trial considered by researchers for other reasons； Participation in another device or drug trial simultaneously.

Ages Eligible for Study
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Minimum Age: 30 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RIC group<br>RIC is a non-invasive therapy that is performed by automated pneumatic cuffs placed on bilateral arms. The RIC protocol includes five cycles of 5-min inflation to 200mmHg and 5-min deflation. | Device: RIC<br>* RIC is a non-invasive therapy that is performed by automated pneumatic cuffs placed on bilateral arms. The RIC protocol includes five cycles of 5-min inflation to 200mmHg and 5-min deflation.<br>|
| Sham Comparator: Sham RIC group<br>The Sham-RIC protocol include five cycles of 5-min inflation to 60 mmHg and 5-min deflation by placing automated pneumatic cuffs on bilateral arms. | Device: Sham-RIC<br>* The Sham-RIC protocol include five cycles of 5-min inflation to 60 mmHg and 5-min deflation by placing automated pneumatic cuffs on bilateral arms.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes of 24 h average systolic blood pressure | Changes of 24 h average systolic blood pressure from baseline to 8 weeks | from baseline to 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes of 24 h average diasolic blood pressure | Changes of 24 h average diasolic blood pressure from baseline to 8 weeks | from baseline to 8 weeks | 
| Changes of daytime average systolic blood pressure | Changes of daytime average systolic blood pressure from baseline to 8 weeks | from baseline to 8 weeks | 
| Changes of daytime average diastolic blood pressure | Changes of daytime average diastolic blood pressure from baseline to 8 weeks | from baseline to 8 weeks | 
| Changes of nighttime average systolic blood pressure | Changes of nighttime average systolic blood pressure from baseline to 8 weeks | from baseline to 8 weeks | 
| Changes of nighttime average diastolic blood pressure | Changes of nighttime average diastolic blood pressure from baseline to 8 weeks | from baseline to 8 weeks | 
| Changes of 24 h average heart rate | Changes of 24 h average heart rate from baseline to 8 weeks | from baseline to 8 weeks | 
| Changes of office systolic blood pressure | Changes of office systolic blood pressure from baseline to 8 weeks | from baseline to 8 weeks | 
| Changes of office diastolic blood pressure | Changes of office diastolic blood pressure from baseline to 8 weeks | from baseline to 8 weeks | 
| Changes of home systolic blood pressure | Changes of home systolic blood pressure from baseline to 8 weeks | from baseline to 8 weeks | 
| Changes of home diastolic blood pressure | Changes of home diastolic blood pressure from baseline to 8 weeks | from baseline to 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Resistant Hypertension, Remote ischemic conditioning