Essential HypertensionPhase 2NCT03566654
Clinical Trial on Remote Ischemic Conditioning and Hypertension（HOPE）
A Phase 2 study testing remote ischemic conditioning and ambulatory blood pressure monitoring in people with Essential Hypertension, run by Ji Xunming,MD,PhD at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 30 to 90 years
- Conditions the study is for
- Essential Hypertension
- What is being tested?
- remote ischemic conditioning and ambulatory blood pressure monitoring
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- 1 siteChina
- Study dates
- 30 Aug 2018to Dec 2019
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Xuan Wu Hospital，Capital Medical University
Beijing, Beijing Municipality, 100069
xunming ji, 861013120136877, jixunming@vip.163.com
About this study
Official title: 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.
Read the 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
- Being tested
- remote ischemic conditioning, ambulatory blood pressure monitoring, Sham remote ischemic conditioning
- Keywords
- remote ischemic conditioning
- Medical subject headings
- Essential Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
remote ischemic conditioningDevice
Also called RIC
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 monitoringDevice
Also called ABPM
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 conditioningDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| remote ischemic conditioning | Experimental | Receiving remote ischemic conditioning (RIC) treatment with pressure set at 200 mmHg. Receives: Device: remote ischemic conditioning; Device: ambulatory blood pressure monitoring |
| placebo remote ischemic conditioning | Sham comparator | Receiving sham RIC treatment with pressure set at 50~60 mmHg Receives: Device: ambulatory blood pressure monitoring; Device: Sham remote ischemic conditioning |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes of blood pressure
systolic, diastolic and average blood pressure changes would be tested after interventions by using ambulatory blood pressure monitoring
Measured: 0-33 days
Secondary outcomes (1)
changes of the circulatory inflammatory factors
circulatory inflammatory factors will be tested before and after the treatment
Measured: 0-33 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2018
- Study start30 Aug 2018
- Primary completionDec 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Essential HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ji Xunming,MD,PhD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ji Xunming,MD,PhD, Capital Medical University
- Investigators
- Xunming Ji, MD,Ph.D, Principal investigator, Capital Medical University Xuan Wu Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03566654
- Sponsor's protocol ID
- RIC-HP
- Status last verified
- Sep 2019
- First submitted
- 27 Mar 2018
- Last updated
- 13 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Random Controlled, Double-Blind Clinical Trial: Remote Ischemic Conditioning and Hypertension
- ClinicalTrials.gov ID
- NCT03566654
- Acronym / sponsor ID
- RIC-HP
- Conditions
- Essential Hypertension
- Keywords
- remote ischemic conditioning
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Ji Xunming,MD,PhDUniversity, hospital or other
- Study start
- 30 Aug 2018 (actual)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 25 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| remote ischemic conditioning | Experimental | Device: remote ischemic conditioning, Device: ambulatory blood pressure monitoringReceiving remote ischemic conditioning (RIC) treatment with pressure set at 200 mmHg. |
| placebo remote ischemic conditioning | Sham comparator | Device: ambulatory blood pressure monitoring, Device: Sham remote ischemic conditioningReceiving sham RIC treatment with pressure set at 50~60 mmHg |
Who may qualify
- Ages
- 30 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| remote ischemic conditioningAlso: RICRIC 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. | Device | remote ischemic conditioning |
| ambulatory blood pressure monitoringAlso: ABPMA 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 | placebo remote ischemic conditioning, remote ischemic conditioning |
| Sham remote ischemic conditioningSham 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. | Device | placebo remote ischemic conditioning |
Primary outcome
changes of blood pressure
Time frame: 0-33 days
systolic, diastolic and average blood pressure changes would be tested after interventions by using ambulatory blood pressure monitoring
1 secondary outcome
changes of the circulatory inflammatory factors
Time frame: 0-33 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2019.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xunming Ji, MD,Ph.D principal investigator
Capital Medical University Xuan Wu Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing remote ischemic conditioning and ambulatory blood pressure monitoring in people with Essential Hypertension, run by Ji Xunming,MD,PhD at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xunming Ji, MD PhD (861013120136877, jixunming@vip.163.com;yingmudao1990@icould.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
changes of blood pressure (time frame: 0-33 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2019.