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

Henan Institute of Cardiovascular Epidemiology

Status: Enrolling

Conditions: Hypertension

Treatments: Other: Antihypertensive drugs; Behavioral: lifestyle intervention; Other: remote ischemic preconditioning（RIPC）

Study type: Interventional

Funder types: Other

Identifiers

NCT04753840

HenanICE202103

Details and patient eligibility

About

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.

Full 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.

Enrollment: 90 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 3 patient groups

Experimental A: Drug group+lifestyle intervention

Experimental group

Description:

Experimental group A used only one antihypertensive drug (ACEI / ARB, beta blocker, calcium channel blocker, diuretic, etc.) plus lifestyle intervention to control blood pressure.

Treatment:

Behavioral: lifestyle intervention

Other: Antihypertensive drugs

Experimental B: RIPC group+lifestyle intervention

Experimental group

Description:

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.

Treatment:

Other: remote ischemic preconditioning（RIPC）

Behavioral: lifestyle intervention

Experimental c: lifestyle intervention

Other group

Description:

The control group take lifestyle intervention to control blood pressure, such as changing dietary habits, smoking cessation and alcohol restriction, exercise and so on.

Treatment:

Behavioral: lifestyle intervention