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

Henan Institute of Cardiovascular Epidemiology

Status: Enrolling

Conditions: Hypertension

Treatments: Other: sham MFT; Behavioral: MFT; Other: sham CRIC; Device: CRIC

Study type: Interventional

Funder types: Other

Identifiers

NCT04753840

HenanICE202103

Details and patient eligibility

About

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.

Full 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.

Enrollment: 400 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Quadruple Blind

---

400 participants in 4 patient groups, including a placebo group

CRIC+MFT

Experimental group

Description:

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.

Treatment:

Device: CRIC

Behavioral: MFT

sham CRIC+MFT

Experimental group

Description:

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.

Treatment:

Other: sham CRIC

Behavioral: MFT

CRIC+sham MFT

Experimental group

Description:

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.

Treatment:

Device: CRIC

Other: sham MFT

Sham CRIC+Sham MFT

Placebo Comparator group

Description:

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.

Treatment:

Other: sham CRIC

Other: sham MFT