Safety and Efficacy of Remote Ischemic Conditioning Treatment for Community-based Essential Hypertension

NCT ID: NCT03945305

Last Updated: 2024-02-28

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 500 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-01
• Study Completion Date: 2024-04-28

Brief Summary

The purpose of this study is to explore the efficacy and safety of remote ischemic conditioning for essential hypertension in the community population.

Detailed Description

At present, stroke has become the leading cause of death in China, with hypertension being the primary risk factor and one of the controllable risk factors. 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 for essential hypertension in the community population.

Conditions

Essential Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

RIC group

Patients are treated with previous antihypertensive treatment plus remote ischemic conditioning.

Group Type: ACTIVE_COMPARATOR

Patients are treated with previous antihypertensive treatment plus remote ischemic conditioning.

Intervention Type: DEVICE

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 mmHg.

Control group

Patients are only treated with previous antihypertensive treatment.

Group Type: OTHER

Previous antihypertensive treatment

Intervention Type: OTHER

Patients are only treated with previous antihypertensive treatment.

Interventions

Patients are treated with previous antihypertensive treatment plus 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 mmHg.

Intervention Type: DEVICE

Previous antihypertensive treatment

Patients are only treated with previous antihypertensive treatment.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Age≥40 years, ≤ 75 years, regardless of sex;

2. Having the history of essential hypertension and the systolic blood pressure of at least 140 mm Hg on two consective days;

3. Signed and dated informed consent is obtained

Exclusion Criteria

1. Blood pressure ≥ 180/110mmHg;

2. Planned adjustment of antihypertensive drugs in the next month;

3. Severe hematologic disorders or significant coagulation abnormalities;

4. 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;

5. Pregnant or lactating women;

6. Severe hepatic and renal dysfunction, or ALT/AST >3 times upper limit of normal, or serum creatinine >265umol/l (>3mg/dl);

7. Patients being enrolled or having been enrolled in another clinical trial within the 3 months prior to this clinical trial;

8. Patients unsuitable for enrollment in the clinical trial according to the investigator's discretion.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yi Yang

OTHER

Sponsor Role: lead

Responsible Party

Yi Yang

Associated Dean of First Hospital of Jilin University

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

First Hospital of Jilin University

Changchun, Jilin, China

Site Status: RECRUITING

Countries

China

Central Contacts

Yi Yang, MD,PhD

Role: CONTACT

doctor_yangyi@163.com

0086-13756661217

Zhen-Ni Guo, MD

Role: CONTACT

zhen1ni2@163.com

Facility Contacts

Yi Yang, MD, PhD

Role: primary

doctor_yangyi@163.com

Other Identifiers

SERIC-EH

Identifier Type: -

Identifier Source: org_study_id