Long-term of Remote Ischemic Preconditioning and Mindfulness in Patients With Hypertension
Hypertension
What this study involves
The registry does not currently label this study as recruiting. Ask about its status before planning a screening visit.
- Study type
- Interventional
- Phase
- Not applicable
- Age range
- 18 years - 80 years
- Sex eligible
- All sexes
- Healthy volunteers
- Not accepted
- Participants
- 600 Actual
These are starting points, not an eligibility decision. The research team must review the full requirements.
About the research
Hypertension is a major risk factor for cardiovascular disease. Remote ischemic conditioning (RIC) and mindfulness-based interventions are non-pharmacological approaches that may help reduce blood pressure through different physiological mechanisms. However, evidence regarding their long-term effects and potential combined benefits remains limited.
This multicenter, randomized, sham-controlled clinical trial evaluated the effects of RIC, mindfulness-based intervention, and their combination on home blood pressure in patients with hypertension. A total of 600 participants were randomly assigned to four groups in a 2×2 factorial design. The interventions were administered twice daily for 12 months. The primary objective was to assess changes in home systolic blood pressure after 12 months of intervention. Secondary objectives included evaluating diastolic blood pressure, the time course of blood pressure changes, treatment response, and safety.
Read the full description
This was a multicenter, randomized, sham-controlled, 2×2 factorial clinical trial conducted at five hospitals in China. A total of 600 patients with essential hypertension were enrolled between September 2023 and August 2024 and randomly assigned in a 1:1:1:1 ratio to four intervention groups:
1. Control group: sham remote ischemic conditioning (RIC) combined with nature-sound audio.
2. RIC group: active RIC combined with nature-sound audio.
3. Mindfulness group: sham RIC combined with guided mindfulness intervention.
4. Combination group: active RIC combined with guided mindfulness intervention.
Active RIC consisted of three cycles of upper-arm cuff inflation for 6 minutes followed by deflation for 4 minutes, with a total session duration of 30 minutes. Inflation pressure was individualized according to baseline systolic blood pressure using predefined pressure increments. Sham RIC followed the same inflation-deflation schedule with a cuff pressure of 60 mmHg.
The mindfulness intervention consisted of standardized audio-guided mindfulness practice delivered simultaneously with the cuff intervention. The control audio consisted of natural sounds, such as ocean waves, flowing water, and birdsong, without hypertension education or mindfulness instructions. Both interventions were administered twice daily for 12 months.
Home blood pressure was measured repeatedly throughout the study using an automated monitoring system. The primary outcome was the change in pre-intervention home systolic blood pressure from baseline to 12 months. Additional assessments included diastolic blood pressure, longitudinal blood pressure trajectories, blood pressure control and response rates, immediate blood pressure responses, treatment adherence, and adverse events.
Selected circulating biomarkers were also measured in a subset of participants for mechanistic investigations.
The study was designed to assess the independent and combined effects of RIC and mindfulness-based intervention on long-term blood pressure control.
Who may be able to participate?
The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.
Inclusion Criteria:
- Adults aged 18-80 years.
- Diagnosis of essential hypertension according to established clinical guidelines, with a mean screening home systolic blood pressure (SBP) of 135-179 mmHg and a mean home diastolic blood pressure (DBP) below 105 mmHg.
- Participants who were either untreated or receiving antihypertensive medication with inadequately controlled blood pressure. For participants receiving antihypertensive medication, drug classes and doses had to remain stable for at least 4 weeks before enrollment, with no planned active adjustment during the study.
- Completion of at least 2 weeks of twice-daily home blood pressure monitoring during screening, with the mean home SBP remaining within 135-179 mmHg before randomization.
- Ability and willingness to perform twice-daily home blood pressure monitoring and complete the 12-month intervention and follow-up.
- Provision of written informed consent.
Exclusion Criteria:
- Secondary hypertension of any cause or incomplete screening for secondary causes of hypertension.
- Cardiovascular or cerebrovascular events within 6 months before enrollment.
- Clinically significant arrhythmias, including atrial fibrillation or frequent ventricular premature beats, that could interfere with automated blood pressure measurement.
- Peripheral vascular disease, severe upper-limb vascular insufficiency, or conditions precluding safe cuff inflation, including an arteriovenous fistula in the measurement arm, lymphedema, skin lesions, or upper-limb surgery within the preceding 3 months.
- Orthostatic hypotension, defined as a systolic blood pressure decrease of at least 20 mmHg on standing or symptomatic orthostatic hypotension.
- Inter-arm systolic blood pressure difference greater than 15 mmHg.
- Severe target-organ damage, including estimated glomerular filtration rate (eGFR) below 30 mL/min/1.73 m², left ventricular ejection fraction (LVEF) below 40%, or New York Heart Association (NYHA) functional class III-IV.
- Poorly controlled diabetes mellitus (HbA1c ≥9.0%) or established diabetic autonomic neuropathy.
- Pregnancy, planned pregnancy, or lactation.
- Participation in another interventional clinical trial within 30 days before enrollment.
- Inability to comply with the study protocol because of cognitive impairment, severe psychiatric disorders, or logistical difficulties with follow-up.
- Confirmed mean screening home DBP ≥105 mmHg on repeat measurement.
Treatment, groups and participation
The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.
- Assignment
- Random assignment
- Masking
- Quadruple masked
CRIC+MFT
CRIC :Twice daily for 12 months 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.
Device: CRIC · Behavioral: MFT
sham CRIC+MFT
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.
Behavioral: MFT · Other: sham CRIC
CRIC+sham MFT
CRIC :Twice daily for 12 months 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.
Device: CRIC · Other: sham MFT
Sham CRIC+Sham MFT
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.
Other: sham CRIC · Other: sham MFT
CRIC DEVICE
Remote Ischemic Conditioning (CRIC): Twice daily for 12 months 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 BEHAVIORAL
Mindfulness-based intervention (MFT) consisted of standardized audio-guided mindfulness practice focusing on breath awareness, bodily sensations, and nonjudgmental present-moment awareness. Each session lasted approximately 30 minutes and was delivered twice daily for 12 months, synchronized with the CRIC or sham CRIC procedure.
sham CRIC OTHER
Mindfulness-based intervention (MFT) consisted of standardized audio-guided mindfulness practice focusing on breath awareness, bodily sensations, and nonjudgmental present-moment awareness. Each session lasted approximately 30 minutes and was delivered twice daily for 12 months, synchronized with the CRIC or sham CRIC procedure.
sham MFT OTHER
The control audio consisted of standardized recordings of natural sounds, including ocean waves, flowing water, and birdsong, without mindfulness instructions, breathing exercises, or hypertension-related health education. Each audio session lasted approximately 30 minutes and was delivered twice daily for 12 months, synchronized with the CRIC or sham CRIC procedure.
What researchers are measuring
Outcome measures describe what is being studied. They are not proof that a treatment works.
Primary measures
Change From Baseline in Home Systolic Blood Pressure at 12 Months
Time frame: Baseline (screening days -7 to -1) and Month 12 (days 335-364 after randomization)
Change in mean pre-intervention home systolic blood pressure (SBP) from screening baseline to the 12-month endpoint window. Home blood pressure was measured twice daily using an automated device. Three measurements were obtained before each intervention session; the first reading was excluded, and the mean of the remaining two readings was used. The 12-month endpoint was calculated as the mean of valid pre-intervention SBP measurements during days 335-364 after randomization. Participants with at least 20 valid measurement sessions during this window were included in the primary endpoint analysis. The outcome was expressed in mmHg.
Secondary measures
Change From Baseline in Home Diastolic Blood Pressure at 12 Months
Time frame: Baseline (screening days -7 to -1) and Month 12 (days 335-364)
Change in mean pre-intervention home diastolic blood pressure (DBP) from screening baseline to the 12-month endpoint window. Home blood pressure was measured twice daily using an automated device. Three measurements were obtained before each intervention session; the first reading was discarded, and the mean of the remaining two readings was used. The 12-month endpoint was calculated as the mean of valid pre-intervention DBP measurements during days 335-364 after randomization. Changes were expressed in mmHg.
Change From Baseline in Home Systolic Blood Pressure at Months 1, 3, 6, and 9
Time frame: Baseline and Days 30, 90, 180, and 270 after randomization
Changes in mean pre-intervention home systolic blood pressure (SBP) from screening baseline at multiple follow-up time points. Home SBP was measured twice daily using an automated device, with the mean of the second and third pre-intervention readings used for each session. Window-mean SBP values were calculated around days 30, 90, 180, and 270 after randomization to characterize the longitudinal blood pressure response to the assigned interventions. Changes were expressed in mmHg.
Proportion of Participants Achieving a Systolic Blood Pressure Reduction of at Least 5 mmHg
Time frame: Baseline and Month 12 (days 335-364)
Proportion of participants achieving a reduction of at least 5 mmHg in mean pre-intervention home systolic blood pressure from screening baseline to the 12-month endpoint window (days 335-364 after randomization). The response rate was calculated as the number of participants meeting this threshold divided by the number of participants with evaluable endpoint data, expressed as a percentage.
Proportion of Participants Achieving Home Blood Pressure Control Below 135/85 mmHg
Time frame: Month 12 (days 335-364)
Proportion of participants achieving home blood pressure control, defined as a mean pre-intervention home systolic blood pressure below 135 mmHg and a mean pre-intervention home diastolic blood pressure below 85 mmHg during the 12-month endpoint window (days 335-364 after randomization). Blood pressure control rates were expressed as percentages among participants with evaluable endpoint data.
Proportion of Participants Achieving Home Blood Pressure Control Below 140/90 mmHg
Time frame: Month 12 (days 335-364)
Proportion of participants achieving home blood pressure control using a less stringent threshold, defined as a mean pre-intervention home systolic blood pressure below 140 mmHg and a mean pre-intervention home diastolic blood pressure below 90 mmHg during the 12-month endpoint window (days 335-364 after randomization). Blood pressure control rates were expressed as percentages among participants with evaluable endpoint data.
Within-Session Change in Home Systolic Blood Pressure
Time frame: Throughout the 12-month intervention period
The immediate blood pressure response was assessed as the difference between post-intervention and pre-intervention home systolic blood pressure within each treatment session. Three consecutive blood pressure measurements were obtained before and after each session, with the first reading excluded and the mean of the remaining two readings used for each time point. The participant-level mean of post-intervention minus pre-intervention SBP differences was calculated across available sessions. Between-group comparisons relative to the double-sham control group were used to estimate the net immediate intervention effect, expressed in mmHg.
Review the complete result tables and limitations in the official record.
Open official results ↗Research locations (5)
The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.
5 locations
Anyang District HospitalAnyang, Henan, ChinaStatus unknown
Huaihe Hospital of Henan UniversityKaifeng, Henan, ChinaStatus unknown
Yongcheng Central HospitalShangqiu, Henan, ChinaStatus unknown
Fuwai central China Cardiovascular hospitalZhengzhou, Henan, ChinaStatus unknown
The First Affiliated Hospital of Henan University of Science and TechnologyLuoyang, ChinaStatus unknown
Study team and timeline
- Lead sponsor
- Henan Institute of Cardiovascular Epidemiology
- Study start
- Sep 1, 2023 Actual
- Primary completion
- Aug 31, 2025 Actual
- Study completion
- Jan 1, 2026 Actual
- First posted
- Feb 15, 2021 Actual
- Last updated
- Nov 10, 2026 Actual
Official study contacts
No central contact is listed. Check the locations and the official record.
Official study title
Long-term of Remote Ischemic Preconditioning and Mindfulness in Patients With Hypertension
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Source: ClinicalTrials.gov API v2. Information is submitted by sponsors and investigators. NLM does not approve the safety or science of all listed studies. Registry disclaimer.
Retrieved: Nov 12, 2026 · Last registry update: Nov 10, 2026