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

Not Applicable

Recruiting

• Conditions: Essential Hypertension
• Interventions: Procedure: Remote ischemic conditioning; Procedure: Sham remote ischemic conditioning

• Registration Number: NCT05910242
• Lead Sponsor: Yi Yang

Brief Summary

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

Detailed 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.

Study Timeline

• Study First Submitted: 2023-06-07
• Study First Submitted QC: 2023-06-15
• Study First Posted: 2023-06-18
• Study Start: 2023-06-20
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-26
• Last Update Posted: 2024-02-28
• Primary Completion: 2024-03-01
• Study Completion: 2024-03-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 102

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
RIC group	Remote ischemic conditioning	Patients are treated with remote ischemic conditioning (RIC).
Sham RIC group	Sham remote ischemic conditioning	Patients are treated with sham remote ischemic conditioning (sham-RIC).

Primary Outcome Measures

Name	Time	Method
Mean systolic blood pressure	1-7 days	Difference in mean systolic blood pressure during RIC/sham-RIC between two groups.

Secondary Outcome Measures

Name	Time	Method
Mean diastolic blood pressure	1-7 days	Difference in mean diastolic blood pressure during RIC/sham-RIC between two groups.

Trial Locations

Locations (1)

The First Hospital of Jilin University; 🇨🇳 Changchun, Jilin, China