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Safety and Feasibility of Remote Ischemic Conditioning on Prehypertension and Early-stage Hypertension

Safety and Feasibility of Remote Ischemic Conditioning on Prehypertension and Early-Stage Hypertension

Status
UNKNOWN
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04254432
Enrollment
20
Registered
2020-02-05
Start date
2019-06-30
Completion date
2020-03-30
Last updated
2020-02-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Early Stage Hypertension, Prehypertension, Remote Ischemic Conditioning

Keywords

hypertension, remote ischemic conditioning

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

Interventions

DEVICEremote ischemic conditioning

RIC is a physical strategy performed by an electric auto-control device with cuffs placed on unilateral arms and inflated to 200 mmHg for 5-min followed by deflation for 5-min, the procedures are performed repeatedly for 5 times# two times per day. The duration of the treatment is 4 weeks.

Sponsors

Capital Medical University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
tolerability and feasibility of remote ischemic conditioning on hypertension4 weeksthere are 56 treatments in totall during 4weeks, the percentage of the completement of each treatment would be used to mearure the tolerance.

Secondary

MeasureTime frameDescription
safety of remote ischemic conditioning on hypertension4 weeksall the adverse effect would be recorded and the percetage of adverse effect happened in the group would be used to measure the safety.

Other

MeasureTime frameDescription
clinical efficacy of remote ischemic conditioning on hyperetension4 weeksthe systolic blood pressure and diastolic blood pressure before and after the treatment would be recorded. the defference between baseline BP and that after treatment would be used to measure efficacy.

Countries

China

Contacts

Primary Contactyu gao
yingmudao1990@gmail.com8613051119757

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026