Safety and Efficacy of Remote Ischemic Conditioning Treatment for Community-based Essential Hypertension
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Patients are treated with previous antihypertensive treatment plus remote ischemic conditioning., Previous antihypertensive treatment.
- Who it may be relevant to
- Registry conditions: Essential Hypertension. Basic parameters: 30 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Safety and Efficacy of Remote Ischemic Conditioning Treatment for Community-based Essential Hypertension: a Randomized, Parallel-controlled Clinical Trial
Overview
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.
Interventions
- Device 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. - Other Previous antihypertensive treatment
Patients are only treated with previous antihypertensive treatment.
Primary outcome measures
- Changes of mean systolic blood pressure [Time frame: 12-14 days]
Secondary outcome measures (4)
- Mean systolic blood pressure level [Time frame: 12-14 days]
- Changes of mean diastolic blood pressure [Time frame: 12-14 days]
- Mean diastolic blood pressure level [Time frame: 12-14 days]
- Blood pressure target achievement rate [Time frame: 14 days]
Eligibility criteria
Inclusion criteria
- Age≥30 years, ≤ 75 years, regardless of sex;
- Patients with a history of essential hypertension and systolic blood pressure (SBP) ≥140 mmHg in three blood pressure measurements performed on separate days within 3 days prior to enrollment.
- Signed and dated informed consent is obtained.
Exclusion criteria
- Blood pressure ≥ 180/110mmHg;
- Planned adjustment of antihypertensive drugs within the next 3 weeks;
- 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;
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- First Hospital of Jilin University — Changchun
Identifiers
NCT: NCT03945305 · SERIC-EH