Clinical trial NCT04753840: Long-term of Remote Ischemic Preconditioning in Patients With Mild Hypertension
Official title: Long-term of Remote Ischemic Preconditioning in Patients With Mild Hypertension
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hypertension
Lead sponsor: Henan Institute of Cardiovascular Epidemiology
Sponsor class: OTHER
First posted: 2021-02-15
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Mean systolic blood pressure
timeFrame: 3 months
measure: Mean diastolic blood pressure
timeFrame: 3 months
Secondary outcomes:
measure: Concentration of Renalase
timeFrame: 3 months
measure: Concentration of catecholamine
timeFrame: 3 months
measure: Concentration of adenosine
timeFrame: 3 months
measure: Concentration of bradykinin
timeFrame: 3 months
measure: Concentration of renin
timeFrame: 3 months
Other outcomes:
Locations:
city: Zhengzhou
country: China
facility: Fuwai central China Cardiovascular hospital
state: Henan
Study officials:
affiliation: Chinese Academy of Medical Sciences, Fuwai Hospital
name: Muwei Li, MD
role: STUDY_CHAIR
References:
citation: 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.
citation: Moro 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.