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

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04753840
• Other study ID #: HenanICE202103
• Status: Recruiting
• Phase: N/A
• Start date: July 3, 2021
• Est. completion date: February 20, 2023

Study information

• Verified date: August 2022
• Source: Henan Institute of Cardiovascular Epidemiology
• Contact: En Li
• Phone: 13525070525
• Email: 1799077212[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: February 20, 2023
• Est. primary completion date: February 20, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hypertension

Intervention

Other:
• Antihypertensive drugs
One of ACEI / ARB, beta blocker, calcium channel blocker, diuretic
• remote ischemic preconditioning(RIPC)
40 minutes per day, 10 minutes as a cycle (cuff inflated to 200 mmHg and maintained for 5 minutes, then deflated for 5 minutes to start the next cycle), a total of 4 cycles.

Behavioral:
• lifestyle intervention
Such as changing dietary habits, smoking cessation and alcohol restriction, exercise and so on.

Locations

Country	Name	City	State
China	Fuwai central China Cardiovascular hospital	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Henan Institute of Cardiovascular Epidemiology

Country where clinical trial is conducted

China, 

References & Publications (2)

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. — View Citation

Moro L, Pedone C, Mondì 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean systolic blood pressure	24-hour Mean systolic blood pressure measured by Ambulatory blood pressure monitoring	3 months
Primary	Mean diastolic blood pressure	24-hour Mean diastolic blood pressure measured by Ambulatory blood pressure monitoring	3 months
Secondary	Concentration of Renalase	blood renalase concentration	3 months
Secondary	Concentration of catecholamine	Blood catecholamine concentration	3 months
Secondary	Concentration of adenosine	blood adenosine concentration	3 months
Secondary	Concentration of bradykinin	blood bradykinin concentration	3 months
Secondary	Concentration of renin	blood renin concentration	3 months