Safety and Feasibility of Remote Ischemic Conditioning on Prehypertension and Early-stage Hypertension

Safety and Feasibility of Remote Ischemic Conditioning on Prehypertension and Early-Stage Hypertension

Nowadays, the incidence of stroke in China has reached 1.6‰, and this disease has become a primary cause of death in China. One of its major risk factors is hypertension. As shown in the researches, the risk of stroke grows remarkably when the blood pressure increases and there exists a log-linear relationship between them. Systolic pressure and diastolic pressure relate to the risk of stroke independently. Systolic pressure decreasing 10mmHg will reduce the stroke risk by 31% and a decrease of 1~3mmHg will reduce the stroke risk by20~30%. As to diastolic pressure, a 5mmHg decrease will reduce the stroke risk by 34% and a 10mmHg decrease will reduce the stroke risk by 56%.In addition, patients with isolated systolic hypertension (SPB≥160mmHg, DPB≤90mmHg) or critical isolated systolic hypertension (SPB=140~159mmHg, DPB< 90mmHg) will suffer a higher risk of stroke than people with normal blood pressure. The ACC has already revised its Hypertension ManagementGuidelines of the standard of diagnosis for hypertension and the timing of starting medical treatment in hypertensive patients. Because more and more researches shown that people with blood pressure between 120-139/80-89mmHg have higher risk of ASCVSD compared to those with blood pressure lower than120/80mmHg; However, in China, the diagnostic criteria for hypertension has not been revised yet. Therefore, we still have a blind spot in treating such patients who suffer from borderline systolic hypertension at 130~140 mmHg of blood-pressure with or without ASCVD or those with the first stage hypertension but refusing to take anti-hypertension drugs. What is more, most of them are middle-aged adults, once they have a stroke, it would lead to terrible and costly consequences to both their family and society. Thus, it is necessary to explore new non-pharmacological methods to control blood pressure for reducing the risk of stroke

Study Overview

• Status: Unknown
• Conditions: Prehypertension; Remote Ischemic Conditioning; Early Stage Hypertension
• Intervention / Treatment: Device: remote ischemic conditioning

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: yu gao; Phone Number: 8613051119757; Email: yingmudao1990@gmail.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100053
      • Recruiting
      • Xuanwu Hospital, Capital Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• systolic blood pressure between 160 and 125 mmHg or diastolic blood pressure between 80 and 100 mmHg
• age≥18
• essential hypertension
• patient did not take anti-hypertensive medicine regularly

Exclusion Criteria:

• patients with severe uncontrolled diabetes
• contraindication for remote ischemic preconditioning
• life expectancy less than 1 year
• patients with atrial fibrillation or other kind of arrhythmia
• unwilling to be followed up or poor compliance.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: remote ischemic conditioning arm; Device: remote ischemic conditioningRIC is a physical strategy performed by an electric auto-control device with cuffs placed on unilateral arms and inflated to 200 mmHg for 5-min followed by deflation for 5-min, the procedures are performed repeatedly for 5 times# two times per day. The duration of the treatment is 30+/-2days. Other Names:• RICDevice: ambulatory blood pressure monitoring diagnostic technique for measuring blood pressure in daily life by means of automatic intermittent timing. Because ABPM has overcome the limitations of clinic blood pressure measurement, observation error and white coat effect, it can objectively reflect the actual level and fluctuation of blood pressure. Each patient of the two arms will use ABPM measure blood pressure before and after RIC or sham RIC treatment

Device: remote ischemic conditioning; RIC is a physical strategy performed by an electric auto-control device with cuffs placed on unilateral arms and inflated to 200 mmHg for 5-min followed by deflation for 5-min, the procedures are performed repeatedly for 5 times# two times per day. The duration of the treatment is 4 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
tolerability and feasibility of remote ischemic conditioning on hypertension	there are 56 treatments in totall during 4weeks， the percentage of the completement of each treatment would be used to mearure the tolerance.	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
safety of remote ischemic conditioning on hypertension	all the adverse effect would be recorded and the percetage of adverse effect happened in the group would be used to measure the safety.	4 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
clinical efficacy of remote ischemic conditioning on hyperetension	the systolic blood pressure and diastolic blood pressure before and after the treatment would be recorded. the defference between baseline BP and that after treatment would be used to measure efficacy.	4 weeks

Collaborators and Investigators

• Sponsor: Capital Medical University

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 30, 2019
• Primary Completion (ACTUAL): January 2, 2020
• Study Completion (ANTICIPATED): March 30, 2020

Study Registration Dates

• First Submitted: January 22, 2020
• First Submitted That Met QC Criteria: February 3, 2020
• First Posted (ACTUAL): February 5, 2020

Study Record Updates

• Last Update Posted (ACTUAL): February 5, 2020
• Last Update Submitted That Met QC Criteria: February 3, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: remote ischemic conditioning; hypertension
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Hypertension; Ischemia; Prehypertension
• Other Study ID Numbers: RIC-HP-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No