Clinical Trial on Remote Ischemic Conditioning and Hypertension（HOPE）
A Random Controlled, Double-Blind Clinical Trial: Remote Ischemic Conditioning and Hypertension
1 other identifier
interventional
180
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Aug 2018
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 27, 2018
CompletedFirst Posted
Study publicly available on registry
June 25, 2018
CompletedStudy Start
First participant enrolled
August 30, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2019
CompletedSeptember 13, 2019
September 1, 2019
1.3 years
March 27, 2018
September 11, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
changes of the circulatory inflammatory factors
0-33 days
Study Arms (2)
remote ischemic conditioning
EXPERIMENTALReceiving remote ischemic conditioning (RIC) treatment with pressure set at 200 mmHg.
placebo remote ischemic conditioning
SHAM COMPARATORReceiving sham RIC treatment with pressure set at 50\~60 mmHg
Interventions
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.
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 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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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;
- \. unstable general condition; 8.Subject participating in a study involving other drug or device trial study; 9. patients that investigators think is not suitable.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Xuan Wu Hospital，Capital Medical University
Beijing, Beijing Municipality, 100069, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Xunming Ji, MD,Ph.D
Capital Medical University Xuan Wu Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor of Neurosurgery, Vice-President of Xuan Wu Hospital, Capital Medical University
Study Record Dates
First Submitted
March 27, 2018
First Posted
June 25, 2018
Study Start
August 30, 2018
Primary Completion
December 1, 2019
Study Completion
December 1, 2019
Last Updated
September 13, 2019
Record last verified: 2019-09
Data Sharing
- IPD Sharing
- Will share