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

Essential Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05910242
• Other study ID #: RICBP-EH
• Status: Recruiting
• Phase: N/A
• Start date: June 20, 2023
• Est. completion date: March 1, 2024

Study information

• Verified date: February 2024
• Source: The First Hospital of Jilin University
• Contact: Yi Yang, MD,PhD
• Phone: 0086-13756661217
• Email: doctor_yangyi[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 102
• Est. completion date: March 1, 2024
• Est. primary completion date: March 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Essential Hypertension
• Hypertension

Intervention

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 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.

Locations

Country	Name	City	State
China	The First Hospital of Jilin University	Changchun	Jilin

Sponsors (1)

Lead Sponsor	Collaborator
Yi Yang

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean systolic blood pressure	Difference in mean systolic blood pressure during RIC/sham-RIC between two groups.	1-7 days
Secondary	Mean diastolic blood pressure	Difference in mean diastolic blood pressure during RIC/sham-RIC between two groups.	1-7 days