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

Primary Purpose

Essential Hypertension

Status
Not yet recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Remote ischemic conditioning
Sham remote ischemic conditioning
Sponsored by
Yi Yang
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Essential Hypertension

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 Exclusion Criteria: 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.

Sites / Locations

  • The First Hospital of Jilin University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

RIC group

Sham RIC group

Arm Description

Patients are treated with remote ischemic conditioning (RIC).

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
June 7, 2023
Last Updated
June 15, 2023
Sponsor
Yi Yang
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1. Study Identification

Unique Protocol Identification Number
NCT05910242
Brief Title
Efficacy and Safety of Remote Ischemic Conditioning in the Treatment of Essential Hypertension (RICBP-EH)
Official Title
Efficacy and Safety of Remote Ischemic Conditioning in the Treatment of Essential Hypertension
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 1, 2023 (Anticipated)
Primary Completion Date
March 1, 2024 (Anticipated)
Study Completion Date
March 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Yi Yang

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Essential Hypertension

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
102 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
RIC group
Arm Type
Active Comparator
Arm Description
Patients are treated with remote ischemic conditioning (RIC).
Arm Title
Sham RIC group
Arm Type
Sham Comparator
Arm Description
Patients are treated with sham remote ischemic conditioning (sham-RIC).
Intervention Type
Procedure
Intervention Name(s)
Remote ischemic conditioning
Intervention Description
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
Intervention Name(s)
Sham remote ischemic conditioning
Intervention Description
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.
Primary Outcome Measure Information:
Title
Mean systolic blood pressure
Description
Difference in mean systolic blood pressure during RIC/sham-RIC between two groups.
Time Frame
1-7 days
Secondary Outcome Measure Information:
Title
Mean diastolic blood pressure
Description
Difference in mean diastolic blood pressure during RIC/sham-RIC between two groups.
Time Frame
1-7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yi Yang, MD,PhD
Phone
0086-13756661217
Email
doctor_yangyi@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Zhenni Guo, MD,PhD
Email
zhen1ni2@163.com
Facility Information:
Facility Name
The First Hospital of Jilin University
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130000
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yi Yang, MD,PhD
Email
doctor_yangyi@163.com

12. IPD Sharing Statement

Learn more about this trial

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

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