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

Efficacy and Safety of Remote Ischemic Conditioning in the Treatment of Essential Hypertension

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

Study Overview

• Status: Recruiting
• Conditions: Essential Hypertension
• Intervention / Treatment: Procedure: Remote ischemic conditioning; Procedure: Sham remote ischemic conditioning

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 Type: Interventional
• Enrollment (Estimated): 102
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yi Yang, MD,PhD; Phone Number: 0086-13756661217; Email: doctor_yangyi@163.com
• Study Contact Backup: Name: Zhenni Guo, MD,PhD; Email: zhen1ni2@163.com

Study Locations

• China
  • Jilin
    • Changchun, Jilin, China, 130000
      • Recruiting
      • The first hospital of Jilin University
      • Contact: Yi Yang, MD,PHD; Email: doctor_yangyi@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: RIC group; Patients are treated with remote ischemic conditioning (RIC).	Procedure: 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.
Sham Comparator: Sham RIC group; Patients are treated with sham remote ischemic conditioning (sham-RIC).	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean systolic blood pressure	Difference in mean systolic blood pressure during RIC/sham-RIC between two groups.	1-7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean diastolic blood pressure	Difference in mean diastolic blood pressure during RIC/sham-RIC between two groups.	1-7 days

Collaborators and Investigators

• Sponsor: Yi Yang

Study record dates

Study Major Dates

• Study Start (Actual): June 20, 2023
• Primary Completion (Estimated): March 1, 2024
• Study Completion (Estimated): March 1, 2024

Study Registration Dates

• First Submitted: June 7, 2023
• First Submitted That Met QC Criteria: June 15, 2023
• First Posted (Actual): June 18, 2023

Study Record Updates

• Last Update Posted (Actual): February 28, 2024
• Last Update Submitted That Met QC Criteria: February 26, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension; Essential Hypertension
• Other Study ID Numbers: RICBP-EH

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No