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NCT Number: NCT04753840

Long-term of Remote Ischemic Preconditioning and Mindfulness in Patients With Mild Hypertension

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fuwai central China Cardiovascular hospital

Zhengzhou, Henan, 450008, China

Location status: Recruiting

Location contact

Muwei Li, MD

CONTACT

[email protected]

+8613838083966

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosed patients with mild hypertension (SBP: 140~159mmHg; DBP: 90~99mmHg)

Exclusion criteria

  • 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.

Treatment and study plan

CRIC

Device

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).

MFT

Behavioral

Sham CRIC: Identical schedule and device; each cycle used fixed 5 min inflation at 60 mmHg (non-ischemic) followed by 5 min deflation.

sham CRIC

Other

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

Other

Sham MFT: Twice daily equivalent-duration audio of looped neutral nature sounds (ocean waves, flowing water, birdsong) without mindfulness instructions.

Primary outcomes

  1. Mean systolic blood pressure

    Time frame: 3 months

    24-hour Mean systolic blood pressure measured by Ambulatory blood pressure monitoring

  2. Mean diastolic blood pressure

    Time frame: 3 months

    24-hour Mean diastolic blood pressure measured by Ambulatory blood pressure monitoring

Secondary outcomes

  1. Concentration of Renalase

    Time frame: 3 months

    blood renalase concentration

  2. Concentration of catecholamine

    Time frame: 3 months

    Blood catecholamine concentration

  3. Concentration of adenosine

    Time frame: 3 months

    blood adenosine concentration

  4. Concentration of bradykinin

    Time frame: 3 months

    blood bradykinin concentration

  5. Concentration of renin

    Time frame: 3 months

    blood renin concentration

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsors and collaborators

Lead sponsor

Henan Institute of Cardiovascular Epidemiology

Other

Registry information

Important dates

Study start
2021
Primary completion
2026
Study completion
2030
First posted
Feb 15, 2021
Registry last updated
Apr 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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