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

NCT ID: NCT04753840

Last Updated: 2025-09-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-03

Study Completion Date

2030-12-01

Brief Summary

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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

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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.

Conditions

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Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Experimental A: Drug group+lifestyle intervention

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

Group Type EXPERIMENTAL

Antihypertensive drugs

Intervention Type OTHER

One of ACEI / ARB, beta blocker, calcium channel blocker, diuretic

lifestyle intervention

Intervention Type BEHAVIORAL

Such as changing dietary habits, smoking cessation and alcohol restriction, exercise and so on.

Experimental B: RIPC group+lifestyle intervention

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.

Group Type EXPERIMENTAL

remote ischemic preconditioning(RIPC)

Intervention Type OTHER

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.

lifestyle intervention

Intervention Type BEHAVIORAL

Such as changing dietary habits, smoking cessation and alcohol restriction, exercise and so on.

Experimental c: lifestyle intervention

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

Group Type OTHER

lifestyle intervention

Intervention Type BEHAVIORAL

Such as changing dietary habits, smoking cessation and alcohol restriction, exercise and so on.

Interventions

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Antihypertensive drugs

One of ACEI / ARB, beta blocker, calcium channel blocker, diuretic

Intervention Type OTHER

remote ischemic preconditioning(RIPC)

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.

Intervention Type OTHER

lifestyle intervention

Such as changing dietary habits, smoking cessation and alcohol restriction, exercise and so on.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Henan Institute of Cardiovascular Epidemiology

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Muwei Li, MD

Role: STUDY_CHAIR

Chinese Academy of Medical Sciences, Fuwai Hospital

Locations

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Fuwai central China Cardiovascular hospital

Zhengzhou, Henan, China

Site Status RECRUITING

Countries

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China

Central Contacts

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En Li

Role: CONTACT

13525070525

Facility Contacts

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Muwei Li, MD

Role: primary

+8613838083966

References

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Jones H, Hopkins N, Bailey TG, Green DJ, Cable NT, Thijssen DH. Seven-day remote ischemic preconditioning improves local and systemic endothelial function and microcirculation in healthy humans. Am J Hypertens. 2014 Jul;27(7):918-25. doi: 10.1093/ajh/hpu004. Epub 2014 Mar 13.

Reference Type BACKGROUND
PMID: 24627443 (View on PubMed)

Moro L, Pedone C, Mondi A, Nunziata E, Antonelli Incalzi R. Effect of local and remote ischemic preconditioning on endothelial function in young people and healthy or hypertensive elderly people. Atherosclerosis. 2011 Dec;219(2):750-2. doi: 10.1016/j.atherosclerosis.2011.08.046. Epub 2011 Sep 7.

Reference Type BACKGROUND
PMID: 21945497 (View on PubMed)

Other Identifiers

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HenanICE202103

Identifier Type: -

Identifier Source: org_study_id

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