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出境医 / 临床实验 / Safety and Efficacy of Remote Ischemic Conditioning in Patients With Essential Hypertension (SERIC-EH)

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

Study Description
Brief Summary:
The purpose of this study is to determine the efficacy and safety of remote ischemic conditioning for essential hypertension.

Condition or disease Intervention/treatment Phase
Essential Hypertension Device: Remote Ischemic Conditioning Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Remote Ischemic Conditioning in Patients With Essential Hypertension
Estimated Study Start Date : January 1, 2021
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : July 31, 2022
Arms and Interventions
Arm Intervention/treatment
Experimental: RIC+ antihypertensive treatment
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.
 Device: 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.
Outcome Measures
Primary Outcome Measures :
  1. changes of blood pressure [ Time Frame: 3+ (30±2) days ]
    systolic, diastolic and average blood pressure changes would be compared between baseline and RIC period.


Secondary Outcome Measures :
  1. changes of heart rate [ Time Frame: 3+ (30±2) days ]
    heart rate would be compared between baseline and RIC period.

  2. changes of blood pressure variability [ Time Frame: 3+ (30±2) days ]
    blood pressure variability would be compared between baseline and RIC period.

  3. changes of heart rate variability [ Time Frame: 3+ (30±2) days ]
    heart rate variability would be compared between baseline and RIC period.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. Concurrent use of anticoagulation drugs including Warfarin, dabigatran, rivaroxaban;
  2. Severe hematologic disease;
  3. Severe hepatic and renal dysfunction;
  4. 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;
  5. Pregnant or lactating women;
  6. Coagulopathy defined as international normalized ratio (INR), activated partial thromboplastin time (APTT), and Prothrombin time (PT) beyond the upper limit of normal range;
  7. Patients being enrolled or having been enrolled in other clinical trial within 3 months prior to this clinical trial;
  8. A high likelihood that the patient will not adhere to the study treatment and follow up regimen;
  9. Patients unsuitable for enrollment in the clinical trial according to investigators decision making.
Contacts and Locations

Contacts
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Contact: Yi Yang, MD,PhD 0086-13756661217 doctor_yangyi@163.com
Contact: Zhen-Ni Guo, MD zhen1ni2@163.com

Locations
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China, Jilin
First Hospital of Jilin University
Changchun, Jilin, China, 130000
Sponsors and Collaborators
Yi Yang
Investigators
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Study Chair: Yi Yang, MD,PhD Department of Neurology, The First Hospital of Jilin University
Tracking Information
First Submitted Date  ICMJE May 8, 2019
First Posted Date  ICMJE May 10, 2019
Last Update Posted Date July 28, 2020
Estimated Study Start Date  ICMJE January 1, 2021
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 12, 2019) 		changes of blood pressure [ Time Frame: 3+ (30±2) days ]
systolic, diastolic and average blood pressure changes would be compared between baseline and RIC period.
Original Primary Outcome Measures  ICMJE
 (submitted: May 8, 2019) 		changes of blood pressure [ Time Frame: 3+ (30±2) days ]
systolic, diastolic and average blood pressure changes would be compared between baseline and RIC peroid.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 12, 2019)
  • changes of heart rate [ Time Frame: 3+ (30±2) days ]
    heart rate would be compared between baseline and RIC period.
  • changes of blood pressure variability [ Time Frame: 3+ (30±2) days ]
    blood pressure variability would be compared between baseline and RIC period.
  • changes of heart rate variability [ Time Frame: 3+ (30±2) days ]
    heart rate variability would be compared between baseline and RIC period.
Original Secondary Outcome Measures  ICMJE
 (submitted: May 8, 2019)
  • changes of heart rate [ Time Frame: 3+ (30±2) days ]
    heart rate would be compared between baseline and RIC peroid.
  • changes of blood pressure variability [ Time Frame: 3+ (30±2) days ]
    blood pressure variability would be compared between baseline and RIC peroid.
  • changes of heart rate variability [ Time Frame: 3+ (30±2) days ]
    heart rate variability would be compared between baseline and RIC peroid.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy of Remote Ischemic Conditioning in Patients With Essential Hypertension (SERIC-EH)
Official Title  ICMJE Safety and Efficacy of Remote Ischemic Conditioning in Patients With Essential Hypertension
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Essential Hypertension
Intervention  ICMJE Device: 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.
Study Arms  ICMJE Experimental: RIC+ antihypertensive treatment
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.
Intervention: Device: Remote Ischemic Conditioning
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: May 8, 2019) 		1000
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 31, 2022
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

  1. Concurrent use of anticoagulation drugs including Warfarin, dabigatran, rivaroxaban;
  2. Severe hematologic disease;
  3. Severe hepatic and renal dysfunction;
  4. 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;
  5. Pregnant or lactating women;
  6. Coagulopathy defined as international normalized ratio (INR), activated partial thromboplastin time (APTT), and Prothrombin time (PT) beyond the upper limit of normal range;
  7. Patients being enrolled or having been enrolled in other clinical trial within 3 months prior to this clinical trial;
  8. A high likelihood that the patient will not adhere to the study treatment and follow up regimen;
  9. Patients unsuitable for enrollment in the clinical trial according to investigators decision making.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Yi Yang, MD,PhD 0086-13756661217 doctor_yangyi@163.com
Contact: Zhen-Ni Guo, MD zhen1ni2@163.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03945305
Other Study ID Numbers  ICMJE SERIC-EH
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Yi Yang, The First Hospital of Jilin University
Study Sponsor  ICMJE Yi Yang
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Yi Yang, MD,PhD Department of Neurology, The First Hospital of Jilin University
PRS Account The First Hospital of Jilin University
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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