Back to results

Safety and Efficacy of Remote Ischemic Conditioning in Patients With Essential Hypertension (SERIC-EH)

Primary Purpose

Essential Hypertension

Status

Not yet recruiting

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Remote Ischemic Conditioning

About this trial

This is an interventional treatment trial for Essential Hypertension focused on measuring Essential Hypertension, Remote Ischemic Conditioning

Eligibility Criteria

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

Inclusion Criteria:

Age≥18 years, < 80 years, regardless of sex;
Patients with essential hypertension who are currently taking oral antihypertensive drugs and still have poor blood pressure control (> 130/80mmHg) ;
the changing of antihypertensive drugs are avoided;
Signed and dated informed consent is obtained

Exclusion Criteria:

Concurrent use of anticoagulation drugs including Warfarin, dabigatran, rivaroxaban;
Severe hematologic disease;
Severe hepatic and renal dysfunction;
The patients who had the contraindication of remote ischemic conditioning treatment, such as severe soft tissue injury, fracture or vascular injury in the upper limb；Acute or subacute venous thrombosis, arterial occlusive disease, subclavian steal syndrome, etc;
Pregnant or lactating women;
Coagulopathy defined as international normalized ratio (INR), activated partial thromboplastin time (APTT), and Prothrombin time (PT) beyond the upper limit of normal range;
Patients being enrolled or having been enrolled in other clinical trial within 3 months prior to this clinical trial;
A high likelihood that the patient will not adhere to the study treatment and follow up regimen;
Patients unsuitable for enrollment in the clinical trial according to investigators decision making.

Sites / Locations

First Hospital of Jilin University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

RIC+ antihypertensive treatment

Arm Description

Baseline blood pressure and heart rate are measured 2 times a day for 3 days. And then the blood pressure and heart rate are measured before and after remote ischemic conditioning. Remote ischemic conditioning (RIC) is induced by 4 cycles of 5 min of upper limb ischemia followed by 5 min reperfusion. Limb ischemia was induced by inflations of a blood pressure cuff to 200 mm Hg. RIC will be conducted twice daily for 30±2 days.

Outcomes

Primary Outcome Measures

changes of blood pressure

systolic, diastolic and average blood pressure changes would be compared between baseline and RIC period.

Secondary Outcome Measures

changes of heart rate

heart rate would be compared between baseline and RIC period.

changes of blood pressure variability

blood pressure variability would be compared between baseline and RIC period.

changes of heart rate variability

heart rate variability would be compared between baseline and RIC period.

Full Information

NCT ID

NCT03945305

First Posted

May 8, 2019

Last Updated

October 31, 2022

Sponsor

Yi Yang

1. Study Identification

Unique Protocol Identification Number

NCT03945305

Brief Title

Safety and Efficacy of Remote Ischemic Conditioning in Patients With Essential Hypertension (SERIC-EH)

Official Title

Safety and Efficacy of Remote Ischemic Conditioning in Patients With Essential Hypertension

Study Type

Interventional

2. Study Status

Record Verification Date

October 2022

Overall Recruitment Status

Not yet recruiting

Study Start Date

January 3, 2023 (Anticipated)

Primary Completion Date

July 31, 2025 (Anticipated)

Study Completion Date

July 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Yi Yang

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The purpose of this study is to determine the efficacy and safety of remote ischemic conditioning for essential hypertension.

Detailed Description

In this study, 1000 cases of essential hypertension in changping district, Beijing, who are currently taking oral antihypertensive drugs and still have poor blood pressure control (> 130/80mmHg) are included. The duration of the study is 3+ (30±2) days, during which time the changing of antihypertensive drugs are avoided and the types and doses of drugs taken daily are recorded. Baseline blood pressure and heart rate are measured 2 times a day for 3 days. And then the blood pressure and heart rate are measured before and after remote ischemic conditioning for 200mmHg, twice a day, 30±2 days in a row to evaluate the efficacy and safety of remote ischemic conditioning on essential hypertension.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Essential Hypertension

Keywords

Essential Hypertension, Remote Ischemic Conditioning

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

1000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

RIC+ antihypertensive treatment

Arm Type

Experimental

Arm Description

Intervention Type

Device

Intervention Name(s)

Remote Ischemic Conditioning

Intervention Description

Remote ischemic conditioning (RIC) is induced by 4 cycles of 5 min of upper limb ischemia followed by 5 min reperfusion. Limb ischemia was induced by inflations of a blood pressure cuff to 200 mm Hg. RIC will be conducted twice daily for 30±2 days.

Primary Outcome Measure Information:

Title

changes of blood pressure

Description

systolic, diastolic and average blood pressure changes would be compared between baseline and RIC period.

Time Frame

3+ (30±2) days

Secondary Outcome Measure Information:

Title

changes of heart rate

Description

heart rate would be compared between baseline and RIC period.

Time Frame

3+ (30±2) days

Title

changes of blood pressure variability

Description

blood pressure variability would be compared between baseline and RIC period.

Time Frame

3+ (30±2) days

Title

changes of heart rate variability

Description

heart rate variability would be compared between baseline and RIC period.

Time Frame

3+ (30±2) days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age≥18 years, < 80 years, regardless of sex; Patients with essential hypertension who are currently taking oral antihypertensive drugs and still have poor blood pressure control (> 130/80mmHg) ; the changing of antihypertensive drugs are avoided; Signed and dated informed consent is obtained Exclusion Criteria: Concurrent use of anticoagulation drugs including Warfarin, dabigatran, rivaroxaban; Severe hematologic disease; Severe hepatic and renal dysfunction; The patients who had the contraindication of remote ischemic conditioning treatment, such as severe soft tissue injury, fracture or vascular injury in the upper limb；Acute or subacute venous thrombosis, arterial occlusive disease, subclavian steal syndrome, etc; Pregnant or lactating women; Coagulopathy defined as international normalized ratio (INR), activated partial thromboplastin time (APTT), and Prothrombin time (PT) beyond the upper limit of normal range; Patients being enrolled or having been enrolled in other clinical trial within 3 months prior to this clinical trial; A high likelihood that the patient will not adhere to the study treatment and follow up regimen; Patients unsuitable for enrollment in the clinical trial according to investigators decision making.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Yi Yang, MD,PhD

Phone

0086-13756661217

doctor_yangyi@163.com

First Name & Middle Initial & Last Name or Official Title & Degree

Zhen-Ni Guo, MD

zhen1ni2@163.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yi Yang, MD,PhD

Organizational Affiliation

Department of Neurology, The First Hospital of Jilin University

Official's Role

Study Chair

Facility Information:

Facility Name

First Hospital of Jilin University

City

Changchun

State/Province

Jilin

ZIP/Postal Code

130000

Country

China

12. IPD Sharing Statement

Learn more about this trial

Safety and Efficacy of Remote Ischemic Conditioning in Patients With Essential Hypertension (SERIC-EH)

We'll reach out to this number within 24 hrs