Clinical trial NCT04254432: Safety and Feasibility of Remote Ischemic Conditioning on Prehypertension and Early-stage Hypertension
Official title: Safety and Feasibility of Remote Ischemic Conditioning on Prehypertension and Early-Stage Hypertension
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Prehypertension
Remote Ischemic Conditioning
Early Stage Hypertension
Keywords: hypertension
remote ischemic conditioning
Lead sponsor: Capital Medical University
Sponsor class: OTHER
First posted: 2020-02-05
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Nowadays, the incidence of stroke in China has reached 1.6‰, and this disease has become a primary cause of death in China. One of its major risk factors is hypertension. As shown in the researches, the risk of stroke grows remarkably when the blood pressure increases and there exists a log-linear relationship between them. Systolic pressure and diastolic pressure relate to the risk of stroke independently. Systolic pressure decreasing 10mmHg will reduce the stroke risk by 31% and a decrease of 1\~3mmHg will reduce the stroke risk by20\~30%. As to diastolic pressure, a 5mmHg decrease will reduce the stroke risk by 34% and a 10mmHg decrease will reduce the stroke risk by 56%.In addition, patients with isolated systolic hypertension (SPB≥160mmHg, DPB≤90mmHg) or critical isolated systolic hypertension (SPB=140\~159mmHg, DPB\< 90mmHg) will suffer a higher risk of stroke than people with normal blood pressure. The ACC has already revised its Hypertension ManagementGuidelines of the standard of diagnosis for hypertension and the timing of starting medical treatment in hypertensive patients. Because more and more researches shown that people with blood pressure between 120-139/80-89mmHg have higher risk of ASCVSD compared to those with blood pressure lower than120/80mmHg; However, in China, the diagnostic criteria for hypertension has not been revised yet. Therefore, we still have a blind spot in treating such patients who suffer from borderline systolic hypertension at 130\~140 mmHg of blood-pressure with or without ASCVD or those with the first stage hypertension but refusing to take anti-hypertension drugs. What is more, most of them are middle-aged adults, once they have a stroke, it would lead to terrible and costly consequences to both their family and society. Thus, it is necessary to explore new non-pharmacological methods to control blood pressure for reducing the risk of stroke


Eligibility criteria: Inclusion Criteria:

* systolic blood pressure between 160 and 125 mmHg or diastolic blood pressure between 80 and 100 mmHg
* age≥18
* essential hypertension
* patient did not take anti-hypertensive medicine regularly

Exclusion Criteria:

* patients with severe uncontrolled diabetes
* contraindication for remote ischemic preconditioning
* life expectancy less than 1 year
* patients with atrial fibrillation or other kind of arrhythmia
* unwilling to be followed up or poor compliance.

Primary outcomes:
measure: tolerability and feasibility of remote ischemic conditioning on hypertension
timeFrame: 4 weeks
Secondary outcomes:
measure: safety of remote ischemic conditioning on hypertension
timeFrame: 4 weeks
Other outcomes:
measure: clinical efficacy of remote ischemic conditioning on hyperetension
timeFrame: 4 weeks
Locations:
city: Beijing
country: China
facility: Xuanwu Hospital, Capital Medical University
state: Beijing
Study officials:
References: