Safety and Efficacy of Remote Ischemic Conditioning Treatment for Community-based Essential Hypertension: a Randomized, Parallel-controlled Clinical Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Essential Hypertension
- Sponsor
- Yi Yang
- Enrollment
- 500
- Locations
- 1
- Primary Endpoint
- Changes of mean systolic blood pressure
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
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.
Investigators
Yi Yang
Associated Dean of First Hospital of Jilin University
The First Hospital of Jilin University
Eligibility Criteria
Inclusion Criteria
- •Age≥40 years, ≤ 75 years, regardless of sex;
- •Having the history of essential hypertension and the systolic blood pressure of at least 140 mm Hg on two consective days;
- •Signed and dated informed consent is obtained
Exclusion Criteria
- •Blood pressure ≥ 180/110mmHg;
- •Planned adjustment of antihypertensive drugs in the next month;
- •Severe hematologic disorders or significant coagulation abnormalities;
- •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;
- •Pregnant or lactating women;
- •Severe hepatic and renal dysfunction, or ALT/AST \>3 times upper limit of normal, or serum creatinine \>265umol/l (\>3mg/dl);
- •Patients being enrolled or having been enrolled in another clinical trial within the 3 months prior to this clinical trial;
- •Patients unsuitable for enrollment in the clinical trial according to the investigator's discretion.
Outcomes
Primary Outcomes
Changes of mean systolic blood pressure
Time Frame: 12-14 days
The mean systolic blood pressure in the last 3 days of treatment minus baseline mean systolic blood pressure
Secondary Outcomes
- Mean systolic blood pressure level(12-14 days)
- Blood pressure compliance rate(15-28 days)
- Changes of mean diastolic blood pressure(12-14 days)
- Mean diastolic blood pressure level(12-14 days)