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Long-term of Remote Ischemic Preconditioning in Patients With Mild Hypertension

Not Applicable
Conditions
Hypertension
Interventions
Other: Antihypertensive drugs
Other: remote ischemic preconditioning(RIPC)
Behavioral: lifestyle intervention
Registration Number
NCT04753840
Lead Sponsor
Henan Institute of Cardiovascular Epidemiology
Brief Summary

According to the latest survey data of China hypertension annual meeting, there are about 300 million patients with hypertension in China, with 10 million new cases of hypertension each year, and there is an obvious trend of younger people. In particular, young and middle-aged people are in a state of mild hypertension for a long time, which causes great pressure on health and medical treatment. At present, the main clinical measures for mild hypertension are to change their eating habits, quit smoking and alcohol, exercise and other lifestyle changes, as well as drug control. For most patients with mild hypertension, drug control is not the best choice. It has been reported that remote ischemic preconditioning (RIPC) may play an effective role in reducing blood pressure .The purpose of this study was to investigate the extent of long-term application of RIPC to reduce blood pressure in patients with mild hypertension.

Detailed Description

A total of 200 patients with mild hypertension were enrolled in this study, using the method of open label and parallel grouping; 100 cases in the experimental group and 100 cases in the control group, The experimental group was divided into life intervention + drug group and life intervention + ripc group, with 50 patients in each group. The results of 24-hour ambulatory blood pressure monitoring (ABPM) of the three groups were observed before and 3 months after use, including HR, pulse pressure, 24-hour systolic blood pressure, 24-hour diastolic blood pressure, daytime systolic blood pressure, daytime diastolic blood pressure, nighttime systolic blood pressure and nighttime diastolic blood pressure. The changes of renalase, catecholamine, renin, angiotensin - Ⅱ, aldosterone, RhoA kinase, no, adenosine and bradykinin were observed.

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
90
Inclusion Criteria
  • Diagnosed patients with mild hypertension (SBP: 140~159mmHg; DBP: 90~99mmHg)
Exclusion Criteria
  • Cannot tolerate RIPC
  • Non-essential hypertension
  • patients who have uncontrolled severe arrhythmia, diabetes, electrolyte disturbance
  • patients who have severe organic diseases such acute myocardial infarction, cardiac insufficiency, abnormal renal function, etc.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Experimental A: Drug group+lifestyle interventionAntihypertensive drugsExperimental group A used only one antihypertensive drug (ACEI / ARB, beta blocker, calcium channel blocker, diuretic, etc.) plus lifestyle intervention to control blood pressure.
Experimental B: RIPC group+lifestyle interventionremote ischemic preconditioning(RIPC)The experimental group B received ripc treatment of upper limbs every day plus lifestyle intervention until the end of the follow-up. The treatment time was 40 minutes per day, 10 minutes as a cycle (cuff inflated to 200 mmHg and maintained for 5 minutes, then deflated for 5 minutes to start the next cycle), a total of 4 cycles.
Experimental c: lifestyle interventionlifestyle interventionThe control group take lifestyle intervention to control blood pressure, such as changing dietary habits, smoking cessation and alcohol restriction, exercise and so on.
Experimental A: Drug group+lifestyle interventionlifestyle interventionExperimental group A used only one antihypertensive drug (ACEI / ARB, beta blocker, calcium channel blocker, diuretic, etc.) plus lifestyle intervention to control blood pressure.
Experimental B: RIPC group+lifestyle interventionlifestyle interventionThe experimental group B received ripc treatment of upper limbs every day plus lifestyle intervention until the end of the follow-up. The treatment time was 40 minutes per day, 10 minutes as a cycle (cuff inflated to 200 mmHg and maintained for 5 minutes, then deflated for 5 minutes to start the next cycle), a total of 4 cycles.
Primary Outcome Measures
NameTimeMethod
Mean diastolic blood pressure3 months

24-hour Mean diastolic blood pressure measured by Ambulatory blood pressure monitoring

Mean systolic blood pressure3 months

24-hour Mean systolic blood pressure measured by Ambulatory blood pressure monitoring

Secondary Outcome Measures
NameTimeMethod
Concentration of Renalase3 months

blood renalase concentration

Concentration of adenosine3 months

blood adenosine concentration

Concentration of renin3 months

blood renin concentration

Concentration of catecholamine3 months

Blood catecholamine concentration

Concentration of bradykinin3 months

blood bradykinin concentration

Trial Locations

Locations (1)

Fuwai central China Cardiovascular hospital

🇨🇳

Zhengzhou, Henan, China

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