Clinical Trial on Remote Ischemic Conditioning and Hypertension（HOPE）

NCT ID: NCT03566654

Last Updated: 2019-09-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 180 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-30
• Study Completion Date: 2019-12-31

Brief Summary

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.

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.

Conditions

Essential Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

remote ischemic conditioning

Receiving remote ischemic conditioning (RIC) treatment with pressure set at 200 mmHg.

Group Type: EXPERIMENTAL

remote ischemic conditioning

Intervention Type: DEVICE

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.

ambulatory blood pressure monitoring

Intervention Type: DEVICE

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.

placebo remote ischemic conditioning

Receiving sham RIC treatment with pressure set at 50\~60 mmHg

Group Type: SHAM_COMPARATOR

ambulatory blood pressure monitoring

Intervention Type: DEVICE

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.

Sham remote ischemic conditioning

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: DEVICE

Other Intervention Names

RIC; ABPM

Eligibility Criteria

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.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ji Xunming,MD,PhD

OTHER

Sponsor Role: lead

Responsible Party

Ji Xunming,MD,PhD

Professor of Neurosurgery, Vice-President of Xuan Wu Hospital, Capital Medical University

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Xunming Ji, MD,Ph.D

Role: PRINCIPAL_INVESTIGATOR

Capital Medical University Xuan Wu Hospital

Locations

Xuan Wu Hospital，Capital Medical University

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Xunming Ji, MD PhD

Role: CONTACT

jixunming@vip.163.com;yingmudao1990@icould.com

861013120136877

Yu Gao, MD Candidate

Role: CONTACT

yingmudao1990@icould.com

861013051119757

Facility Contacts

xunming ji

Role: primary

jixunming@vip.163.com

861013120136877

Other Identifiers

RIC-HP

Identifier Type: -

Identifier Source: org_study_id