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

NCT05910242 | Completed DMC

• 1 other identifier: RICBP-EH
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Essential Hypertension

Outcome Measures

Primary Outcomes (1)

• Mean systolic blood pressure

  Difference in mean systolic blood pressure during RIC/sham-RIC between two groups.

  1-7 days

Secondary Outcomes (1)

• Mean diastolic blood pressure

  1-7 days

Study Arms (2)

RIC group

ACTIVE COMPARATOR

Patients are treated with remote ischemic conditioning (RIC).

Procedure: Remote ischemic conditioning

Sham RIC group

SHAM COMPARATOR

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

Procedure: Sham remote ischemic conditioning

Interventions

Remote ischemic conditioning 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.

RIC group

Sham remote ischemic conditioning 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.

Sham RIC group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Secondary hypertension;
• Clinical blood pressure ≥ 180/110 mmHg or 24-hour mean arterial pressure ≥ 170/100 mmHg;
• Severe organ dysfunction or failure;
• Severe hematologic disorders or significant coagulation abnormalities;
• History of atrial fibrillation or myocardial infarction within 6 months;
• 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;
• Individuals who will or have received anticoagulant therapy with drugs such as dabigatran, rivaroxaban, warfarin, etc; ;
• Pregnant or lactating women;
• 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;
• Other conditions that the researchers think are not suitable for the project.

Sponsors & Collaborators

• Yi Yang: lead

Study Sites (1)

The First Hospital of Jilin University

Changchun, Jilin, 130000, China

Location

Related Publications (1)

• 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.

  PMID: 41146928 DERIVED

MeSH Terms

Conditions

Essential Hypertension

Condition Hierarchy (Ancestors)

Hypertension; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associated Dean of The First Hospital of Jilin University

Study Record Dates

• First Submitted: June 7, 2023
• First Posted: June 18, 2023
• Study Start: June 20, 2023
• Primary Completion: March 6, 2024
• Study Completion: March 6, 2024
• Last Updated: June 3, 2025

Record last verified: 2025-05

Locations

CN (1)