Clinical Trial on Remote Ischemic Conditioning and Hypertension（HOPE）

A Random Controlled, Double-Blind Clinical Trial: Remote Ischemic Conditioning and Hypertension

Nowadays, the incidence of stroke in China has reached 1.6‰, and this disease has became 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 decrease of 1~3mmHg will reduce the stroke risk by 20~30%. As to diastolic pressure, 5mmHg decrease of it will reduce the stroke risk by 34% and 10mmHg decrease of it 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 Management Guidelines of standard of diagnosis for hypertension and timing of starting medical treatment in hypertensive patients.Because more and more reseaches shown that people with blood pressure between 120-139/80-89mmHg have higher risk of ASCVSD compared to those with blood pressure lower than 120/80mmHg; However, in China, the diagnostic criteria for hypertension has not been revised yet. Therefore, we still have 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 stroke, it would lead terrible and costly consequences to both their family and the 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: Essential Hypertension
• Intervention / Treatment: Device: remote ischemic conditioning; Device: ambulatory blood pressure monitoring; Device: Sham remote ischemic conditioning

Detailed Description

There already have had some researchers found the phenomenon of lowing blood pressure among heart failure patients and pre-hypertensive individuals after a long-term of ischemic conditioning therapy. However, there's still lack of specific clinical trials carried out to confirm itspotential treatment effect of lowing blood pressure.

The investigators designed this randomized, doubleblind, controlled clinical trial to examine (1) whether RIC has a beneficial effect on blood pressure; (2) whether RIC exert its protection effect through immunological regulation. There are 2 arms in this trial: One arm is RIC treatment, the other one is sham RIC treatment. Blood pressure will be measured by ambulatory blood pressure monitoring before and after the treatment to evaluate its exact effect on BP. Also, circulatory immunological factors will be tested before and after the treatment to illustate whether immunological regulation involved in the process.

• Study Type: Interventional
• Enrollment (Anticipated): 180
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100069
      • Recruiting
      • Xuan Wu Hospital，Capital Medical University
      • Contact: xunming ji; Phone Number: 861013120136877; Email: jixunming@vip.163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. ABPM measures systolic and diastolic blood pressure within the range of 125-145/75-90mmHg;
2. Essential hypertension;
3. without use anti-hypertensive drugs;
4. Written consent was obtained from the subject.

Exclusion Criteria:

1. patients already have had anti-hypertensive drugs;
2. patiets with diabetes mellitus and have a poor blood glucose control;
3. patients with atrial fibrillation or other kinds of arrhythmia;

7. unstable general condition; 8.Subject participating in a study involving other drug or device trial study; 9. patients that investigators think is not suitable.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: remote ischemic conditioning; Receiving remote ischemic conditioning (RIC) treatment with pressure set at 200 mmHg.	Device: remote ischemic conditioning; RIC is a physical strategy performed by an electric autocontrol device with cuffs placed on unilateral arms and inflated to 200 mmHg for 5-min followed by deflation for 5-min, the procedures is performed repeately for 5 times， two times per day. The duration of the treatment is 30+/-2days.; Other Names: RIC; Device: ambulatory blood pressure monitoring; A 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.; Other Names: ABPM
Sham Comparator: placebo remote ischemic conditioning; Receiving sham RIC treatment with pressure set at 50~60 mmHg	Device: ambulatory blood pressure monitoring; A 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.; Other Names: ABPM; Device: Sham remote ischemic conditioning; Sham RIC is a physical strategy performed by an electric autocontrol device with cuffs placed on unilateral arms and inflated to 60 mmHg for 5-min followed by deflation for 5-min, the procedures is performed repeately for 5 times. The duration of the treatment is 30+/-2days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
changes of blood pressure	systolic, diastolic and average blood pressure changes would be tested after interventions by using ambulatory blood pressure monitoring	0-33 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
changes of the circulatory inflammatory factors	circulatory inflammatory factors will be tested before and after the treatment	0-33 days

Collaborators and Investigators

• Sponsor: Ji Xunming,MD,PhD
• Investigators: Principal Investigator: Xunming Ji, MD,Ph.D, Capital Medical University Xuan Wu Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 30, 2018
• Primary Completion (Anticipated): December 1, 2019
• Study Completion (Anticipated): December 1, 2019

Study Registration Dates

• First Submitted: March 27, 2018
• First Submitted That Met QC Criteria: June 12, 2018
• First Posted (Actual): June 25, 2018

Study Record Updates

• Last Update Posted (Actual): September 13, 2019
• Last Update Submitted That Met QC Criteria: September 11, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: remote ischemic conditioning
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension; Essential Hypertension
• Other Study ID Numbers: RIC-HP

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