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

Yi Yang

Status: Completed

Conditions: Essential Hypertension

Treatments: Procedure: Remote ischemic conditioning; Procedure: Sham remote ischemic conditioning

Study type: Interventional

Funder types: Other

Identifiers

NCT05910242

RICBP-EH

Details and patient eligibility

About

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

Full description

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.

Enrollment: 102 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age≥18 years, regardless of sex;
2. Patients with systolic blood pressure ≥140mmHg with or without taking oral antihypertensive drugs
3. Signed and dated informed consent is obtained

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. Pregnant or lactating women;
9. 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;
10. Other conditions that the researchers think are not suitable for the project.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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102 participants in 2 patient groups

RIC group

Active Comparator group

Description:

Patients are treated with remote ischemic conditioning (RIC).

Treatment:

Procedure: Remote ischemic conditioning

Sham RIC group

Sham Comparator group

Description:

Patients are treated with sham remote ischemic conditioning (sham-RIC).

Treatment:

Procedure: Sham remote ischemic conditioning