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

NCT ID: NCT05910242

Last Updated: 2025-06-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 102 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-20
• Study Completion Date: 2024-03-06

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.

Conditions

Essential Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

RIC group

Patients are treated with remote ischemic conditioning (RIC).

Group Type: ACTIVE_COMPARATOR

Remote ischemic conditioning

Intervention Type: PROCEDURE

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.

Sham RIC group

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

Group Type: SHAM_COMPARATOR

Sham remote ischemic conditioning

Intervention Type: PROCEDURE

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.

Interventions

Remote ischemic conditioning

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.

Intervention Type: PROCEDURE

Sham remote ischemic conditioning

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yi Yang

OTHER

Sponsor Role: lead

Responsible Party

Yi Yang

Associated Dean of The First Hospital of Jilin University

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

The First Hospital of Jilin University

Changchun, Jilin, China

Countries

China

References

Yin WJ, Wang SJ, Qu Y, Ren JX, Zhang P, Abuduxukuer R, Yang Y, Guo ZN. Efficacy of remote ischemic conditioning on blood pressure in essential hypertension in China (RICBP-EH): a randomised, controlled, parallel-group trial. EClinicalMedicine. 2025 Oct 16;89:103562. doi: 10.1016/j.eclinm.2025.103562. eCollection 2025 Nov.

Reference Type: DERIVED

PMID: 41146928 (View on PubMed)

Other Identifiers

RICBP-EH

Identifier Type: -

Identifier Source: org_study_id