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

Not Applicable

Recruiting

• Conditions: Essential Hypertension
• Interventions: Other: Previous antihypertensive treatment; Device: Patients are treated with previous antihypertensive treatment plus remote ischemic conditioning.

• Registration Number: NCT03945305
• Lead Sponsor: Yi Yang

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.

Study Timeline

• Study First Submitted: 2019-05-08
• Study First Submitted QC: 2019-05-08
• Study First Posted: 2019-05-10
• Study Start: 2023-11-01
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-26
• Last Update Posted: 2024-02-28
• Primary Completion: 2024-03-31
• Study Completion: 2024-04-28

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Previous antihypertensive treatment	Patients are only treated with previous antihypertensive treatment.
RIC group	Patients are treated with previous antihypertensive treatment plus remote ischemic conditioning.	Patients are treated with previous antihypertensive treatment plus remote ischemic conditioning.

Primary Outcome Measures

Name	Time	Method
Changes of mean systolic blood pressure	12-14 days	The mean systolic blood pressure in the last 3 days of treatment minus baseline mean systolic blood pressure

Secondary Outcome Measures

Name	Time	Method
Mean systolic blood pressure level	12-14 days	Mean systolic blood pressure levels during the last 3 days of treatment
Blood pressure compliance rate	15-28 days	Blood pressure compliance rates after treatment
Changes of mean diastolic blood pressure	12-14 days	The mean diastolic blood pressure in the last 3 days of treatment minus baseline mean diastolic blood pressure
Mean diastolic blood pressure level	12-14 days	Mean diastolic blood pressure levels during the last 3 days of treatment

Trial Locations

Locations (1)

First Hospital of Jilin University; 🇨🇳 Changchun, Jilin, China