HypertensionNCT04753840
Long-term of Remote Ischemic Preconditioning and Mindfulness in Patients With Mild Hypertension
A study testing CRIC and MFT in people with Hypertension, run by Henan Institute of Cardiovascular Epidemiology at 1 site in China.
Trial summary
According to the latest survey data of China hypertension annual meeting, there are about 300 million patients with hypertension in China, with 10 million new cases of hypertension each year, and there is an obvious trend of younger people. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hypertension
- What is being tested?
- CRIC and MFT
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 400 participants
- Where
- 1 siteChina
- Study dates
- 3 Jul 2021to 1 Dec 2030
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed patients with mild hypertension (SBP: 140~159mmHg; DBP: 90~99mmHg)
Who cannot join
- Cannot tolerate RIPC
- Non-essential hypertension
- patients who have uncontrolled severe arrhythmia, diabetes, electrolyte disturbance
- patients who have severe organic diseases such acute myocardial infarction, cardiac insufficiency, abnormal renal function, etc.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Fuwai central China Cardiovascular hospital
Zhengzhou, Henan, 450008
Muwei Li, MD, +8613838083966, lmw0207@163.com
About this study
According to the latest survey data of China hypertension annual meeting, there are about 300 million patients with hypertension in China, with 10 million new cases of hypertension each year, and there is an obvious trend of younger people. In particular, young and middle-aged people are in a state of mild hypertension for a long time, which causes great pressure on health and medical treatment. At present, the main clinical measures for mild hypertension are to change their eating habits, quit smoking and alcohol, exercise and other lifestyle changes, as well as drug control. For most patients with mild hypertension, drug control is not the best choice. It has been reported that remote ischemic preconditioning (RIPC) may play an effective role in reducing blood pressure .The purpose of this study was to investigate the extent of long-term application of RIPC to reduce blood pressure in patients with mild hypertension.
Read the detailed description
A total of 200 patients with mild hypertension were enrolled in this study, using the method of open label and parallel grouping; 100 cases in the experimental group and 100 cases in the control group, The experimental group was divided into life intervention + drug group and life intervention + ripc group, with 50 patients in each group. The results of 24-hour ambulatory blood pressure monitoring (ABPM) of the three groups were observed before and 3 months after use, including HR, pulse pressure, 24-hour systolic blood pressure, 24-hour diastolic blood pressure, daytime systolic blood pressure, daytime diastolic blood pressure, nighttime systolic blood pressure and nighttime diastolic blood pressure. The changes of renalase, catecholamine, renin, angiotensin - Ⅱ, aldosterone, RhoA kinase, no, adenosine and bradykinin were observed.
- Conditions
- Hypertension
- Being tested
- CRIC, MFT, sham CRIC, sham MFT
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CRICDevice
Remote Ischemic Conditioning (CRIC): Twice daily for 12 weeks using an automated cuff device. Each 30-minute session consisted of 3 cycles of 6 min inflation (pressure individualized: resting SBP-based increments of +40/+30/+20 mmHg depending on baseline SBP level) followed by 4 min deflation (0 mmHg).
MFTBehavioural
Sham CRIC: Identical schedule and device; each cycle used fixed 5 min inflation at 60 mmHg (non-ischemic) followed by 5 min deflation.
sham CRICOther
Sham CRIC: Identical schedule and device; each cycle used fixed 5 min inflation at 60 mmHg (non-ischemic) followed by 5 min deflation.
sham MFTOther
Sham MFT: Twice daily equivalent-duration audio of looped neutral nature sounds (ocean waves, flowing water, birdsong) without mindfulness instructions.
| Study group | Role | What they receive |
|---|---|---|
| CRIC+MFT | Experimental | CRIC :Twice daily for 12 weeks using an automated cuff device. Each 30-minute session consisted of 3 cycles of 6 min inflation (pressure individualized: resting SBP-based increments of +40/+30/+20 mmHg depending on baseline SBP level) followed by 4 min deflation (0 mmHg).
MFT:Twice daily guided audio sessions (synchronized with CRIC timing) emphasizing focused attention on breath and bodily sensations to foster mindful awareness. Receives: Device: CRIC; Behavioral: MFT |
| sham CRIC+MFT | Experimental | Sham CRIC: Identical schedule and device; each cycle used fixed 5 min inflation at 60 mmHg (non-ischemic) followed by 5 min deflation.
MFT: Twice daily guided audio sessions (synchronized with CRIC timing) emphasizing focused attention on breath and bodily sensations to foster mindful awareness. Receives: Behavioral: MFT; Other: sham CRIC |
| CRIC+sham MFT | Experimental | CRIC :Twice daily for 12 weeks using an automated cuff device. Each 30-minute session consisted of 3 cycles of 6 min inflation (pressure individualized: resting SBP-based increments of +40/+30/+20 mmHg depending on baseline SBP level) followed by 4 min deflation (0 mmHg).
Sham MFT: Twice daily equivalent-duration audio of looped neutral nature sounds (ocean waves, flowing water, birdsong) without mindfulness instructions. Receives: Device: CRIC; Other: sham MFT |
| Sham CRIC+Sham MFT | Placebo comparator | Sham CRIC: Identical schedule and device; each cycle used fixed 5 min inflation at 60 mmHg (non-ischemic) followed by 5 min deflation.
Sham MFT: Twice daily equivalent-duration audio of looped neutral nature sounds (ocean waves, flowing water, birdsong) without mindfulness instructions. Receives: Other: sham CRIC; Other: sham MFT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean systolic blood pressure
24-hour Mean systolic blood pressure measured by Ambulatory blood pressure monitoring
Measured: 3 months
Mean diastolic blood pressure
24-hour Mean diastolic blood pressure measured by Ambulatory blood pressure monitoring
Measured: 3 months
Secondary outcomes (5)
Concentration of Renalase
blood renalase concentration
Measured: 3 months
Concentration of catecholamine
Blood catecholamine concentration
Measured: 3 months
Concentration of adenosine
blood adenosine concentration
Measured: 3 months
Concentration of bradykinin
blood bradykinin concentration
Measured: 3 months
Concentration of renin
blood renin concentration
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2021
- Study start3 Jul 2021
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for 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
- Factorial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henan Institute of Cardiovascular Epidemiology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Muwei Li, MD, Study chair, Chinese Academy of Medical Sciences, Fuwai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04753840
- Sponsor's protocol ID
- HenanICE202103
- Status last verified
- Apr 2026
- First submitted
- 10 Feb 2021
- Last updated
- 6 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD can be obtained from the researcher upon reasonable request
Publications
Jones H, Hopkins N, Bailey TG, Green DJ, Cable NT, Thijssen DH. Seven-day remote ischemic preconditioning improves local and systemic endothelial function and microcirculation in healthy humans. Am J Hypertens. 2014 Jul;27(7):918-25. doi: 10.1093/ajh/hpu004. Epub 2014 Mar 13.
PubMed 24627443Moro L, Pedone C, Mondi A, Nunziata E, Antonelli Incalzi R. Effect of local and remote ischemic preconditioning on endothelial function in young people and healthy or hypertensive elderly people. Atherosclerosis. 2011 Dec;219(2):750-2. doi: 10.1016/j.atherosclerosis.2011.08.046. Epub 2011 Sep 7.
PubMed 21945497
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term of Remote Ischemic Preconditioning and Mindfulness in Patients With Mild Hypertension
- ClinicalTrials.gov ID
- NCT04753840
- Acronym / sponsor ID
- HenanICE202103
- Conditions
- Hypertension
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Henan Institute of Cardiovascular EpidemiologyUniversity, hospital or other
- Study start
- 3 Jul 2021 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2030 (estimated)
- First posted
- 15 Feb 2021 (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.
According to the latest survey data of China hypertension annual meeting, there are about 300 million patients with hypertension in China, with 10 million new cases of hypertension each year, and there is an obvious trend of younger people. In particular, young and middle-aged people are in a state of mild hypertension for a long time, which causes great pressure on health and medical treatment. At present, the main clinical measures for mild hypertension are to change their eating habits, quit smoking and alcohol, exercise and other lifestyle changes, as well as drug control. For most patients with mild hypertension, drug control is not the best choice. It has been reported that remote ischemic preconditioning (RIPC) may play an effective role in reducing blood pressure .The purpose of this study was to investigate the extent of long-term application of RIPC to reduce blood pressure in patients with mild hypertension.
Detailed description
A total of 200 patients with mild hypertension were enrolled in this study, using the method of open label and parallel grouping; 100 cases in the experimental group and 100 cases in the control group, The experimental group was divided into life intervention + drug group and life intervention + ripc group, with 50 patients in each group. The results of 24-hour ambulatory blood pressure monitoring (ABPM) of the three groups were observed before and 3 months after use, including HR, pulse pressure, 24-hour systolic blood pressure, 24-hour diastolic blood pressure, daytime systolic blood pressure, daytime diastolic blood pressure, nighttime systolic blood pressure and nighttime diastolic blood pressure. The changes of renalase, catecholamine, renin, angiotensin - Ⅱ, aldosterone, RhoA kinase, no, adenosine and bradykinin were observed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| CRIC+MFT | Experimental | Device: CRIC, Behavioral: MFTCRIC :Twice daily for 12 weeks using an automated cuff device. Each 30-minute session consisted of 3 cycles of 6 min inflation (pressure individualized: resting SBP-based increments of +40/+30/+20 mmHg depending on baseline SBP level) followed by 4 min deflation (0 mmHg). MFT:Twice daily guided audio sessions (synchronized with CRIC timing) emphasizing focused attention on breath and bodily sensations to foster mindful awareness. |
| sham CRIC+MFT | Experimental | Behavioral: MFT, Other: sham CRICSham CRIC: Identical schedule and device; each cycle used fixed 5 min inflation at 60 mmHg (non-ischemic) followed by 5 min deflation. MFT: Twice daily guided audio sessions (synchronized with CRIC timing) emphasizing focused attention on breath and bodily sensations to foster mindful awareness. |
| CRIC+sham MFT | Experimental | Device: CRIC, Other: sham MFTCRIC :Twice daily for 12 weeks using an automated cuff device. Each 30-minute session consisted of 3 cycles of 6 min inflation (pressure individualized: resting SBP-based increments of +40/+30/+20 mmHg depending on baseline SBP level) followed by 4 min deflation (0 mmHg). Sham MFT: Twice daily equivalent-duration audio of looped neutral nature sounds (ocean waves, flowing water, birdsong) without mindfulness instructions. |
| Sham CRIC+Sham MFT | Placebo comparator | Other: sham CRIC, Other: sham MFTSham CRIC: Identical schedule and device; each cycle used fixed 5 min inflation at 60 mmHg (non-ischemic) followed by 5 min deflation. Sham MFT: Twice daily equivalent-duration audio of looped neutral nature sounds (ocean waves, flowing water, birdsong) without mindfulness instructions. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Diagnosed patients with mild hypertension (SBP: 140~159mmHg; DBP: 90~99mmHg)
Key exclusion criteria (4 listed)
- Cannot tolerate RIPC
- Non-essential hypertension
- patients who have uncontrolled severe arrhythmia, diabetes, electrolyte disturbance
- patients who have severe organic diseases such acute myocardial infarction, cardiac insufficiency, abnormal renal function, etc.
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 |
|---|---|---|
| CRICRemote Ischemic Conditioning (CRIC): Twice daily for 12 weeks using an automated cuff device. Each 30-minute session consisted of 3 cycles of 6 min inflation (pressure individualized: resting SBP-based increments of +40/+30/+20 mmHg depending on baseline SBP level) followed by 4 min deflation (0 mmHg). | Device | CRIC+MFT, CRIC+sham MFT |
| MFTSham CRIC: Identical schedule and device; each cycle used fixed 5 min inflation at 60 mmHg (non-ischemic) followed by 5 min deflation. | Behavioural | CRIC+MFT, sham CRIC+MFT |
| sham CRICSham CRIC: Identical schedule and device; each cycle used fixed 5 min inflation at 60 mmHg (non-ischemic) followed by 5 min deflation. | Other | Sham CRIC+Sham MFT, sham CRIC+MFT |
| sham MFTSham MFT: Twice daily equivalent-duration audio of looped neutral nature sounds (ocean waves, flowing water, birdsong) without mindfulness instructions. | Other | CRIC+sham MFT, Sham CRIC+Sham MFT |
Primary outcome
Mean systolic blood pressure
Time frame: 3 months
24-hour Mean systolic blood pressure measured by Ambulatory blood pressure monitoring
Mean diastolic blood pressure
Time frame: 3 months
24-hour Mean diastolic blood pressure measured by Ambulatory blood pressure monitoring
5 secondary outcomes
Concentration of Renalase
Time frame: 3 months
Concentration of catecholamine
Time frame: 3 months
Concentration of adenosine
Time frame: 3 months
Concentration of bradykinin
Time frame: 3 months
Concentration of renin
Time frame: 3 months
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 6 Apr 2026.
- Background: PubMed 24627443Jones H, Hopkins N, Bailey TG, Green DJ, Cable NT, Thijssen DH. Seven-day remote ischemic preconditioning improves local and systemic endothelial function and microcirculation in healthy humans. Am J Hypertens. 2014 Jul;27(7):918-25. doi: 10.1093/ajh/hpu004. Epub 2014 Mar 13.
- Background: PubMed 21945497Moro L, Pedone C, Mondi A, Nunziata E, Antonelli Incalzi R. Effect of local and remote ischemic preconditioning on endothelial function in young people and healthy or hypertensive elderly people. Atherosclerosis. 2011 Dec;219(2):750-2. doi: 10.1016/j.atherosclerosis.2011.08.046. Epub 2011 Sep 7.
- Individual participant dataSharing planned: No. IPD can be obtained from the researcher upon reasonable request
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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.
Muwei Li, MD study chair
Chinese Academy of Medical Sciences, Fuwai Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CRIC and MFT in people with Hypertension, run by Henan Institute of Cardiovascular Epidemiology 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 1 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: looking for participants now, as of the sponsor's last update on 6 Apr 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. 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.
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 En Li (13525070525, 1799077212@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean systolic blood pressure (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04753840, which also lists 2 linked publications.
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 6 Apr 2026.