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

Yi Yang

Status: Enrolling

Conditions: Essential Hypertension

Treatments: Device: Patients are treated with previous antihypertensive treatment plus remote ischemic conditioning.; Other: Previous antihypertensive treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT03945305

SERIC-EH

Details and patient eligibility

About

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

Full 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.

Enrollment: 500 estimated patients

Sex: All

Ages: 40 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

500 participants in 2 patient groups

RIC group

Active Comparator group

Description:

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

Treatment:

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

Control group

Other group

Description:

Patients are only treated with previous antihypertensive treatment.

Treatment:

Other: Previous antihypertensive treatment