Clinical Trial on Remote Ischemic Conditioning and Hypertension(HOPE)
Primary Purpose
Essential Hypertension
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
remote ischemic conditioning
ambulatory blood pressure monitoring
Sham remote ischemic conditioning
Sponsored by
About this trial
This is an interventional treatment trial for Essential Hypertension focused on measuring remote ischemic conditioning
Eligibility Criteria
Inclusion Criteria:
- ABPM measures systolic and diastolic blood pressure within the range of 125-145/75-90mmHg;
- Essential hypertension;
- without use anti-hypertensive drugs;
- Written consent was obtained from the subject.
Exclusion Criteria:
- patients already have had anti-hypertensive drugs;
- patiets with diabetes mellitus and have a poor blood glucose control;
- 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.
Sites / Locations
- Xuan Wu Hospital,Capital Medical UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
remote ischemic conditioning
placebo remote ischemic conditioning
Arm Description
Receiving remote ischemic conditioning (RIC) treatment with pressure set at 200 mmHg.
Receiving sham RIC treatment with pressure set at 50~60 mmHg
Outcomes
Primary Outcome Measures
changes of blood pressure
systolic, diastolic and average blood pressure changes would be tested after interventions by using ambulatory blood pressure monitoring
Secondary Outcome Measures
changes of the circulatory inflammatory factors
circulatory inflammatory factors will be tested before and after the treatment
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03566654
Brief Title
Clinical Trial on Remote Ischemic Conditioning and Hypertension(HOPE)
Official Title
A Random Controlled, Double-Blind Clinical Trial: Remote Ischemic Conditioning and Hypertension
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Unknown status
Study Start Date
August 30, 2018 (Actual)
Primary Completion Date
December 2019 (Anticipated)
Study Completion Date
December 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Ji Xunming,MD,PhD
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Essential Hypertension
Keywords
remote ischemic conditioning
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
180 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
remote ischemic conditioning
Arm Type
Experimental
Arm Description
Receiving remote ischemic conditioning (RIC) treatment with pressure set at 200 mmHg.
Arm Title
placebo remote ischemic conditioning
Arm Type
Sham Comparator
Arm Description
Receiving sham RIC treatment with pressure set at 50~60 mmHg
Intervention Type
Device
Intervention Name(s)
remote ischemic conditioning
Other Intervention Name(s)
RIC
Intervention Description
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
Intervention Name(s)
ambulatory blood pressure monitoring
Other Intervention Name(s)
ABPM
Intervention Description
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
Intervention Name(s)
Sham remote ischemic conditioning
Intervention Description
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.
Primary Outcome Measure Information:
Title
changes of blood pressure
Description
systolic, diastolic and average blood pressure changes would be tested after interventions by using ambulatory blood pressure monitoring
Time Frame
0-33 days
Secondary Outcome Measure Information:
Title
changes of the circulatory inflammatory factors
Description
circulatory inflammatory factors will be tested before and after the treatment
Time Frame
0-33 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
ABPM measures systolic and diastolic blood pressure within the range of 125-145/75-90mmHg;
Essential hypertension;
without use anti-hypertensive drugs;
Written consent was obtained from the subject.
Exclusion Criteria:
patients already have had anti-hypertensive drugs;
patiets with diabetes mellitus and have a poor blood glucose control;
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xunming Ji, MD PhD
Phone
861013120136877
Email
jixunming@vip.163.com;yingmudao1990@icould.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yu Gao, MD Candidate
Phone
861013051119757
Email
yingmudao1990@icould.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xunming Ji, MD,Ph.D
Organizational Affiliation
Capital Medical University Xuan Wu Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Xuan Wu Hospital,Capital Medical University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100069
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
xunming ji
Phone
861013120136877
Email
jixunming@vip.163.com
12. IPD Sharing Statement
Plan to Share IPD
Yes
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Clinical Trial on Remote Ischemic Conditioning and Hypertension(HOPE)
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