Clinical trial NCT02414997: The Effect of Remote Ischemic Preconditioning (RIPC) on Blood Pressure and Its Vascular Protection Effect
Official title: The Effect of Remote Ischemic Preconditioning (RIPC) on Blood Pressure and Its Vascular Protection Effect Among Chinese Young Healthy Adults and Primary Hypertensive Patients Stage I
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Pressure; Brachial Plexus
Keywords: RIPC (remote ischemic preconditioning)
primary hypertension stage I
vascular function
microRNA-126
microRNA-34a
Lead sponsor: First Affiliated Hospital, Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2015-04-13
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the effect of remote ischemic preconditioning (RIPC) on blood pressure and its vascular protection effect among Chinese young healthy adults and primary hypertensive patients stage I.

Detailed description: Hypertension is one of the most common world-wide chronic diseases, and it is one of major independent risk factors of atherosclerotic cardiovascular diseases (ASCVD) especially among middle-aged and elderly. Recently, a study indicates that in a normotensive elderly without cardiovascular diseases history, continuous RIPC for 30 days lowers systolic blood pressure for 6 mmHg and diastolic blood pressure for 3 mmHg. Another study shows a 7-day RIPC intervention improves endothelium-dependent flow mediated dilation(FDM) and cutaneous vascular conductivity(CVC) in 13 healthy young males. In addition, studies demonstrate that microRNA-126 and microRNA-34a are endothelial specific microRNAs which are expressed in human PBMCs. MicroRNA-126 is responsible for keeping the integrity of vascular endothelial, promoting the proliferation, mobilization, and migration of endothelial progenitor cells(EPCs), reducing arterial intimal hyperplasia, and reduce adhesion of neutrophils to vascular endothelial. In contrast, microRNA-34a is related to the aging of endothelial cells, which is found over-expressed in senile endothelial cells. Together the investigators use microRNA-126 and microRNA-34a to explore whether RIPC produces vascular endothelial protection effect. In summary, the investigators propose a hypothesis that RIPC might have a blood pressure lowing effect and protect vascular function both in Chinese healthy young adults and primary hypertensive patients. The term "primary hypertension stage I" indicates those with blood pressures ranging from 140 to 159 mmHg systolic and/or 90 to 99 mmHg diastolic. Accumulating evidences suggest that subjects with primary hypertension stage I are associated with higher incidence of ASCVD. However, there is no available data to investigate a nonpharmacologic therapy for primary hypertension stage I until now, and there is no prospective, randomized, controlled, single-blind clinic trial to investigate the effect of RIPC on blood pressure and its vascular protection effect. The investigators hypothesize that RIPC may lower both SBP and DBP, and it improves vascular function in Chinese healthy young adults and subjects with primary hypertension stage I. To address these assumptions, the present study is designed to study the effect of RIPC on blood pressure and its vascular protection effect, using FMD, PWV, central arterial pressure, RHI(EndoPAT) and the quantification of microRNA-126 and microRNA-34a in peripheral blood monocyte(PBMC) as indicators among Chinese healthy young adults and primary hypertensive patients stage I over a 1-month follow-up period.

Eligibility criteria: Inclusion Criteria:

* Subjects range from 18 to 80 years old.
* Blood pressure is normal or primary hypertension stage I(systolic blood pressure 140 to 159 mmHg and/or diastolic blood pressure 90 to 99 mmHg).
* No history of smoking( smoking can eliminate the effect of RIPC) or quit smoking for at least 1 years.
* No intake of caffeine or caffeine-containing substances during the process of this trial(caffeine can eliminate the effect of RIPC).
* Provide informed consent and willingness to cooperate with the study protocol.

Exclusion Criteria:

* Less than 18 years old or above 80 years old.
* Secondary hypertension.
* Pregnant or lactating females.
* Systemic diseases such as diabetes, HIV/AIDS, liver disease, chronic renal failure, tuberculosis, and autoimmune diseases.
* Medical history of cardiovascular disease: acute myocardial infarct, stable angina, unstable angina, heart failure, atrial fibrillation, atrioventricular blockade, peripheral vascular disease or cerebrovascular accident.
* Patients who are unfavorable of long-term follow-up or poor compliance.
* Patients who are considered unfavorable to take part in this trial by investigators.

Primary outcomes:
measure: Change from Baseline in Systolic Blood Pressure at 1 month
timeFrame: Baseline; 1 week after RIPC; 1 month after RIPC
measure: Change from Baseline in Diastolic Blood Pressure at 1 month
timeFrame: Baseline; 1 week after RIPC; 1 month after RIPC
Secondary outcomes:
measure: Artery elasticity
timeFrame: Baseline; 1 week after RIPC; 1 month after RIPC
measure: Vascular endothelial function - RHI(EndoPAT)
timeFrame: Baseline; 1 week after RIPC; 1 month after RIPC
measure: Quantification of microRNA-126 and microRNA-34a in PBMC (peripheral blood mononuclear cell)
timeFrame: Baseline; 1 week after RIPC; 1 month after RIPC
measure: Migration and adhesion function of endothelial progenitor cells (EPC)
timeFrame: Baseline; 1 week after RIPC; 1 month after RIPC
measure: Endothelial function
timeFrame: Baseline; 1 week after RIPC; 1 month after RIPC
measure: Expression of CXC-chemokine receptor 4 and CXC-chemokine receptor 7 protein of EPC
timeFrame: Baseline; 1 week after RIPC; 1 month after RIPC
Other outcomes:
Locations:
Study officials:
affiliation: First Affiliated Hospital, Sun Yat-Sen University
name: Tao Jun, phD
role: PRINCIPAL_INVESTIGATOR
References: