Essential HypertensionNCT03945305
Safety and Efficacy of Remote Ischemic Conditioning Treatment for Community-based Essential Hypertension
A study testing Patients are treated with previous antihypertensive treatment plus remote ischemic conditioning. and Previous antihypertensive treatment in people with Essential Hypertension, run by Yi Yang at 1 site in China.
Trial summary
The purpose of this study is to explore the efficacy and safety of remote ischemic conditioning for essential hypertension in the community population. Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- Essential Hypertension
- What is being tested?
- Patients are treated with previous antihypertensive treatment plus remote ischemic conditioning. and Previous antihypertensive treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 25 Nov 2023to 31 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age≥30 years, ≤ 75 years, regardless of sex;
- Patients with a history of essential hypertension and systolic blood pressure (SBP) ≥140 mmHg in three blood pressure measurements performed on separate days within 3 days prior to enrollment.
- Signed and dated informed consent is obtained.
Who cannot join
- Blood pressure ≥ 180/110mmHg;
- Planned adjustment of antihypertensive drugs within the next 3 weeks;
- Severe hematologic disorders or significant coagulation abnormalities;
- Individuals who had contraindication of remote ischemic conditioning, such as severe soft tissue injury, fracture or vascular injury in the upper limb, acute or subacute venous thrombosis, arterial occlusive disease, subclavian steal syndrome, etc;
- Pregnant or lactating women;
- Severe hepatic and renal dysfunction;
- Patients being enrolled or having been enrolled in another clinical trial within the 3 months prior to this clinical trial;
- Patients unsuitable for enrollment in the clinical trial according to the investigator's discretion.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Zhen-Ni Guo, MD contact
China1 site, 1 recruiting
- Recruiting
First Hospital of Jilin University
Changchun, Jilin, 130000
Yi Yang, MD, PhD, doctor_yangyi@163.com
About this study
Official title: Safety and Efficacy of Remote Ischemic Conditioning Treatment for Community-based Essential Hypertension: a Randomized, Parallel-controlled Clinical Trial
The purpose of this study is to explore the efficacy and safety of remote ischemic conditioning for essential hypertension in the community population.
Read the detailed description
At present, stroke has become the leading cause of death in China, with hypertension being the primary risk factor and one of the controllable risk factors. Current studies have shown that remote ischemic conditioning can improve vascular endothelial function, inhibit sympathetic nervous system activity and regulate immune and inflammatory reactions. Thus it may exert anti-hypertensive effects through multiple mechanisms. The purpose of this study is to investigate the efficacy and safety of remote ischemic conditioning for essential hypertension in the community population.
- Conditions
- Essential Hypertension
- Being tested
- Patients are treated with previous antihypertensive treatment plus remote ischemic conditioning., Previous antihypertensive treatment
- Keywords
- Essential Hypertension, 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.
Patients are treated with previous antihypertensive treatment plus remote ischemic conditioning.Device
Remote ischemic conditioning (RIC) is induced by 4 cycles of 5 min of upper limb ischemia followed by 5 min reperfusion. Limb ischemia was induced by inflation of a blood pressure cuff to 200 mmHg.
Previous antihypertensive treatmentOther
Patients are only treated with previous antihypertensive treatment.
| Study group | Role | What they receive |
|---|---|---|
| RIC group | Active comparator | Patients are treated with previous antihypertensive treatment plus remote ischemic conditioning. Receives: Device: Patients are treated with previous antihypertensive treatment plus remote ischemic conditioning. |
| Control group | Other | Patients are only treated with previous antihypertensive treatment. Receives: Other: Previous antihypertensive treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of mean systolic blood pressure
The mean systolic blood pressure in the last 3 days of treatment minus baseline mean systolic blood pressure
Measured: 12-14 days
Secondary outcomes (4)
Mean systolic blood pressure level
Mean systolic blood pressure levels during the last 3 days of treatment
Measured: 12-14 days
Changes of mean diastolic blood pressure
The mean diastolic blood pressure in the last 3 days of treatment minus baseline mean diastolic blood pressure
Measured: 12-14 days
Mean diastolic blood pressure level
Mean diastolic blood pressure levels during the last 3 days of treatment
Measured: 12-14 days
Blood pressure target achievement rate
Blood pressure target achievement rate after treatment
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2019
- Study start25 Nov 2023
- Primary completion31 Jul 2026 (estimated)
- Study completion31 Jul 2026 (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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yi Yang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yi Yang, The First Hospital of Jilin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03945305
- Sponsor's protocol ID
- SERIC-EH
- Status last verified
- Jul 2026
- First submitted
- 8 May 2019
- Last updated
- 28 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Remote Ischemic Conditioning Treatment for Community-based Essential Hypertension: a Randomized, Parallel-controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT03945305
- Acronym / sponsor ID
- SERIC-EH
- Conditions
- Essential Hypertension
- Keywords
- Essential Hypertension, Remote Ischemic Conditioning
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Yi YangUniversity, hospital or other
- Study start
- 25 Nov 2023 (actual)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 10 May 2019 (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.
The purpose of this study is to explore the efficacy and safety of remote ischemic conditioning for essential hypertension in the community population.
Detailed description
At present, stroke has become the leading cause of death in China, with hypertension being the primary risk factor and one of the controllable risk factors. Current studies have shown that remote ischemic conditioning can improve vascular endothelial function, inhibit sympathetic nervous system activity and regulate immune and inflammatory reactions. Thus it may exert anti-hypertensive effects through multiple mechanisms. The purpose of this study is to investigate the efficacy and safety of remote ischemic conditioning for essential hypertension in the community population.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RIC group | Active comparator | Device: Patients are treated with previous antihypertensive treatment plus remote ischemic conditioning.Patients are treated with previous antihypertensive treatment plus remote ischemic conditioning. |
| Control group | Other | Other: Previous antihypertensive treatmentPatients are only treated with previous antihypertensive treatment. |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age≥30 years, ≤ 75 years, regardless of sex;
- Patients with a history of essential hypertension and systolic blood pressure (SBP) ≥140 mmHg in three blood pressure measurements performed on separate days within 3 days prior to enrollment.
- Signed and dated informed consent is obtained.
Key exclusion criteria (8 listed)
- Blood pressure ≥ 180/110mmHg;
- Planned adjustment of antihypertensive drugs within the next 3 weeks;
- Severe hematologic disorders or significant coagulation abnormalities;
- Individuals who had contraindication of remote ischemic conditioning, such as severe soft tissue injury, fracture or vascular injury in the upper limb, acute or subacute venous thrombosis, arterial occlusive disease, subclavian steal syndrome, etc;
- Pregnant or lactating women;
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 |
|---|---|---|
| Patients are treated with previous antihypertensive treatment plus remote ischemic conditioning.Remote ischemic conditioning (RIC) is induced by 4 cycles of 5 min of upper limb ischemia followed by 5 min reperfusion. Limb ischemia was induced by inflation of a blood pressure cuff to 200 mmHg. | Device | RIC group |
| Previous antihypertensive treatmentPatients are only treated with previous antihypertensive treatment. | Other | Control group |
Primary outcome
Changes of mean systolic blood pressure
Time frame: 12-14 days
The mean systolic blood pressure in the last 3 days of treatment minus baseline mean systolic blood pressure
4 secondary outcomes
Mean systolic blood pressure level
Time frame: 12-14 days
Changes of mean diastolic blood pressure
Time frame: 12-14 days
Mean diastolic blood pressure level
Time frame: 12-14 days
Blood pressure target achievement rate
Time frame: 14 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2026.
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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.
Zhen-Ni Guo, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patients are treated with previous antihypertensive treatment plus remote ischemic conditioning. and Previous antihypertensive treatment in people with Essential Hypertension, run by Yi Yang 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 3 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 28 Jul 2026. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yi Yang, MD,PhD (0086-13756661217, doctor_yangyi@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes of mean systolic blood pressure (time frame: 12-14 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 28 Jul 2026.