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

Primary Purpose

Prehypertension, Remote Ischemic Conditioning, Early Stage Hypertension

Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
remote ischemic conditioning
Sponsored by
Capital Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prehypertension focused on measuring hypertension, remote ischemic conditioning

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Xuanwu Hospital, Capital Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

remote ischemic conditioning arm

Arm Description

Device: remote ischemic conditioningRIC 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 30+/-2days. Other Names:• RICDevice: ambulatory blood pressure monitoring diagnostic technique for measuring blood pressure in daily life by means of automatic intermittent timing. Because ABPM has overcome the limitations of clinic blood pressure measurement, observation error and white coat effect, it can objectively reflect the actual level and fluctuation of blood pressure. Each patient of the two arms will use ABPM measure blood pressure before and after RIC or sham RIC treatment

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

safety of remote ischemic conditioning on hypertension
all the adverse effect would be recorded and the percetage of adverse effect happened in the group would be used to measure the safety.

Full Information

First Posted
January 22, 2020
Last Updated
February 3, 2020
Sponsor
Capital Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT04254432
Brief Title
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

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Unknown status
Study Start Date
June 30, 2019 (Actual)
Primary Completion Date
January 2, 2020 (Actual)
Study Completion Date
March 30, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Capital Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prehypertension, Remote Ischemic Conditioning, Early Stage Hypertension
Keywords
hypertension, remote ischemic conditioning

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
remote ischemic conditioning arm
Arm Type
Experimental
Arm Description
Device: remote ischemic conditioningRIC 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 30+/-2days. Other Names:• RICDevice: ambulatory blood pressure monitoring diagnostic technique for measuring blood pressure in daily life by means of automatic intermittent timing. Because ABPM has overcome the limitations of clinic blood pressure measurement, observation error and white coat effect, it can objectively reflect the actual level and fluctuation of blood pressure. Each patient of the two arms will use ABPM measure blood pressure before and after RIC or sham RIC treatment
Intervention Type
Device
Intervention Name(s)
remote ischemic conditioning
Intervention Description
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.
Primary Outcome Measure Information:
Title
tolerability and feasibility of remote ischemic conditioning on hypertension
Description
there are 56 treatments in totall during 4weeks, the percentage of the completement of each treatment would be used to mearure the tolerance.
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
safety of remote ischemic conditioning on hypertension
Description
all the adverse effect would be recorded and the percetage of adverse effect happened in the group would be used to measure the safety.
Time Frame
4 weeks
Other Pre-specified Outcome Measures:
Title
clinical efficacy of remote ischemic conditioning on hyperetension
Description
the 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.
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
yu gao
Phone
8613051119757
Email
yingmudao1990@gmail.com
Facility Information:
Facility Name
Xuanwu Hospital, Capital Medical University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100053
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xunming Ji

12. IPD Sharing Statement

Plan to Share IPD
Yes

Learn more about this trial

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

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