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

Sponsor

Yi Yang (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05910242

Collaborator

(none)

102

Enrollment

Location

Arms

Anticipated Duration (Months)

12.7

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Essential Hypertension	Procedure: Remote ischemic conditioning Procedure: Sham remote ischemic conditioning	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

102 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Jul 1, 2023

Anticipated Primary Completion Date :

Mar 1, 2024

Anticipated Study Completion Date :

Mar 1, 2024

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Mean systolic blood pressure [1-7 days]
Difference in mean systolic blood pressure during RIC/sham-RIC between two groups.

Secondary Outcome Measures

Mean diastolic blood pressure [1-7 days]
Difference in mean diastolic blood pressure during RIC/sham-RIC between two groups.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The First Hospital of Jilin University	Changchun	Jilin	China	130000

Sponsors and Collaborators

Yi Yang

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Yi Yang, Associated Dean of The First Hospital of Jilin University, The First Hospital of Jilin University

ClinicalTrials.gov Identifier:

NCT05910242

Other Study ID Numbers:

RICBP-EH

First Posted:

Jun 18, 2023

Last Update Posted:

Jun 18, 2023

Last Verified:

Jun 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Hypertension

Essential Hypertension

Study Results

No Results Posted as of Jun 18, 2023