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Remote Ischemic Conditioning for the Treatment of Resistant Hypertension

Primary Purpose

Resistant Hypertension

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
RIC
Sham-RIC
Sponsored by
Ji Xunming,MD,PhD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Resistant Hypertension focused on measuring Resistant Hypertension, Remote ischemic conditioning

Eligibility Criteria

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

Inclusion Criteria:

  • Aged 30~80 years old;

    • Taking ≥ 3 antihypertensive drugs (including one diuretic) for more than 4 weeks regularly;

      • Office blood pressure ≥ 140/90mmhg, and 24 h average blood pressure ≥ 130/80 mmHg;

        • Willing to participate in the study, follow the study protocol, and provide informed consent.

Exclusion Criteria:

  • Secondary hypertension;

    • eGFR<45ml/min/1.73m2；

      • Office blood pressure ≥180/110 mmHg, and 24 h average blood pressure ≥ 170/100 mmHg；

        • Hypertensive crisis occurred within 3 months;

          • Type 1 diabetes;

            • Cardiovascular events occurred within 3 months;

              • Atrial fibrillation;

                • Presence of any severe disease that adversely affects the subject or study;

                  • Patients with contraindication for remote ischemic conditioning, such as vascular injury, soft tissue injury, orthopedic injury, or arm infection;

                    • Pregnancy, lactation, or planned pregnancy;

                      • Patients not suitable for this trial considered by researchers for other reasons；

                        • Participation in another device or drug trial simultaneously.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Sham Comparator

    Arm Label

    RIC group

    Sham RIC group

    Arm Description

    RIC is a non-invasive therapy that is performed by automated pneumatic cuffs placed on bilateral arms. The RIC protocol includes five cycles of 5-min inflation to 200mmHg and 5-min deflation.

    The Sham-RIC protocol include five cycles of 5-min inflation to 60 mmHg and 5-min deflation by placing automated pneumatic cuffs on bilateral arms.

    Outcomes

    Primary Outcome Measures

    Changes of 24 h average systolic blood pressure
    Changes of 24 h average systolic blood pressure from baseline to 8 weeks

    Secondary Outcome Measures

    Changes of 24 h average diasolic blood pressure
    Changes of 24 h average diasolic blood pressure from baseline to 8 weeks
    Changes of daytime average systolic blood pressure
    Changes of daytime average systolic blood pressure from baseline to 8 weeks
    Changes of daytime average diastolic blood pressure
    Changes of daytime average diastolic blood pressure from baseline to 8 weeks
    Changes of nighttime average systolic blood pressure
    Changes of nighttime average systolic blood pressure from baseline to 8 weeks
    Changes of nighttime average diastolic blood pressure
    Changes of nighttime average diastolic blood pressure from baseline to 8 weeks
    Changes of 24 h average heart rate
    Changes of 24 h average heart rate from baseline to 8 weeks
    Changes of office systolic blood pressure
    Changes of office systolic blood pressure from baseline to 8 weeks
    Changes of office diastolic blood pressure
    Changes of office diastolic blood pressure from baseline to 8 weeks
    Changes of home systolic blood pressure
    Changes of home systolic blood pressure from baseline to 8 weeks
    Changes of home diastolic blood pressure
    Changes of home diastolic blood pressure from baseline to 8 weeks

    Full Information

    First Posted
    June 16, 2022
    Last Updated
    September 3, 2022
    Sponsor
    Ji Xunming,MD,PhD
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05426707
    Brief Title
    Remote Ischemic Conditioning for the Treatment of Resistant Hypertension
    Official Title
    Efficacy and Safety of Remote Ischemic Conditioning for the Treatment of Resistant Hypertension: a Pilot Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 1, 2022 (Anticipated)
    Primary Completion Date
    February 1, 2023 (Anticipated)
    Study Completion Date
    March 30, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Ji Xunming,MD,PhD

    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
    This study aims to explore the efficacy and safety of remote ischemia adaptation for the treatment of resistant hypertension.
    Detailed Description
    Resistant hypertension is defined as a blood pressure of 140/90 mmHg or higher despite adherence to at least three antihypertensive drugs (including one diuretic), accounting for 20% to 30% of patients with hypertension. Compared with patients with well-controlled blood pressure, the cardiovascular risk of resistant hypertension is increased by about 50%. Limb remote ischemic conditioning (LRIC) triggers endogenous protective effects through transient and repeated ischemia in the limb to protect remote tissues and organs. The mechanisms of LRIC involve the regulation of the autonomic nervous system, the release of humoral factors, improvement of vascular endothelial function, and modulation of immune/inflammatory responses, which can antagonize the pathogenesis of hypertension through multiple pathways to lead to a drop in BP theoretically. This theory has been preliminarily confirmed by several small sample-size studies in non-resistant hypertension. This study aims to explore the efficacy and safety of remote ischemia adaptation for the treatment of resistant hypertension.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Resistant Hypertension
    Keywords
    Resistant Hypertension, Remote ischemic conditioning

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    40 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    RIC group
    Arm Type
    Experimental
    Arm Description
    RIC is a non-invasive therapy that is performed by automated pneumatic cuffs placed on bilateral arms. The RIC protocol includes five cycles of 5-min inflation to 200mmHg and 5-min deflation.
    Arm Title
    Sham RIC group
    Arm Type
    Sham Comparator
    Arm Description
    The Sham-RIC protocol include five cycles of 5-min inflation to 60 mmHg and 5-min deflation by placing automated pneumatic cuffs on bilateral arms.
    Intervention Type
    Device
    Intervention Name(s)
    RIC
    Intervention Description
    RIC is a non-invasive therapy that is performed by automated pneumatic cuffs placed on bilateral arms. The RIC protocol includes five cycles of 5-min inflation to 200mmHg and 5-min deflation.
    Intervention Type
    Device
    Intervention Name(s)
    Sham-RIC
    Intervention Description
    The Sham-RIC protocol include five cycles of 5-min inflation to 60 mmHg and 5-min deflation by placing automated pneumatic cuffs on bilateral arms.
    Primary Outcome Measure Information:
    Title
    Changes of 24 h average systolic blood pressure
    Description
    Changes of 24 h average systolic blood pressure from baseline to 8 weeks
    Time Frame
    from baseline to 8 weeks
    Secondary Outcome Measure Information:
    Title
    Changes of 24 h average diasolic blood pressure
    Description
    Changes of 24 h average diasolic blood pressure from baseline to 8 weeks
    Time Frame
    from baseline to 8 weeks
    Title
    Changes of daytime average systolic blood pressure
    Description
    Changes of daytime average systolic blood pressure from baseline to 8 weeks
    Time Frame
    from baseline to 8 weeks
    Title
    Changes of daytime average diastolic blood pressure
    Description
    Changes of daytime average diastolic blood pressure from baseline to 8 weeks
    Time Frame
    from baseline to 8 weeks
    Title
    Changes of nighttime average systolic blood pressure
    Description
    Changes of nighttime average systolic blood pressure from baseline to 8 weeks
    Time Frame
    from baseline to 8 weeks
    Title
    Changes of nighttime average diastolic blood pressure
    Description
    Changes of nighttime average diastolic blood pressure from baseline to 8 weeks
    Time Frame
    from baseline to 8 weeks
    Title
    Changes of 24 h average heart rate
    Description
    Changes of 24 h average heart rate from baseline to 8 weeks
    Time Frame
    from baseline to 8 weeks
    Title
    Changes of office systolic blood pressure
    Description
    Changes of office systolic blood pressure from baseline to 8 weeks
    Time Frame
    from baseline to 8 weeks
    Title
    Changes of office diastolic blood pressure
    Description
    Changes of office diastolic blood pressure from baseline to 8 weeks
    Time Frame
    from baseline to 8 weeks
    Title
    Changes of home systolic blood pressure
    Description
    Changes of home systolic blood pressure from baseline to 8 weeks
    Time Frame
    from baseline to 8 weeks
    Title
    Changes of home diastolic blood pressure
    Description
    Changes of home diastolic blood pressure from baseline to 8 weeks
    Time Frame
    from baseline to 8 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    30 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Aged 30~80 years old; Taking ≥ 3 antihypertensive drugs (including one diuretic) for more than 4 weeks regularly; Office blood pressure ≥ 140/90mmhg, and 24 h average blood pressure ≥ 130/80 mmHg; Willing to participate in the study, follow the study protocol, and provide informed consent. Exclusion Criteria: Secondary hypertension; eGFR<45ml/min/1.73m2； Office blood pressure ≥180/110 mmHg, and 24 h average blood pressure ≥ 170/100 mmHg； Hypertensive crisis occurred within 3 months; Type 1 diabetes; Cardiovascular events occurred within 3 months; Atrial fibrillation; Presence of any severe disease that adversely affects the subject or study; Patients with contraindication for remote ischemic conditioning, such as vascular injury, soft tissue injury, orthopedic injury, or arm infection; Pregnancy, lactation, or planned pregnancy; Patients not suitable for this trial considered by researchers for other reasons； Participation in another device or drug trial simultaneously.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Xunming Ji, MD, PhD
    Phone
    83199430
    Email
    jixm@ccmu.edu.cn
    First Name & Middle Initial & Last Name or Official Title & Degree
    Wenting Guo
    Phone
    18368910464
    Email
    18368910464@163.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Xunming Ji, MD, PhD
    Organizational Affiliation
    Xuanwu Hospital, Beijing
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Remote Ischemic Conditioning for the Treatment of Resistant Hypertension

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