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LEPU Renal Denervation System for Resistant Hypertension (LEPU-RDN)

Primary Purpose

Hypertension, Cardiovascular Diseases, Vascular Diseases

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
LEPU Renal Denervation System
Sponsored by
Lepu Medical Technology (Beijing) Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age 18-65 years
  • Stable medication regimen including ≥3 antihypertensive medications of different classes, including a diuretic (with no changes for a minimum of 4 weeks prior to RDN)
  • 1) Office SBP and/or DBP ≥160/100 mm Hg ( ≥ 150/95 mmHg for type II diabetic patients) , 2) ABPM 24 hour mean SBP and/or DBP ≥140 and/or 90 mmHg
  • Main renal arteries with ≥4 mm diameter or with ≥20 mm treatable length (by visual estimation)
  • eGFR ≥45 mL/min/1.73 m2
  • Written informed consent

Exclusion Criteria:

  1. Clinical Exclusion Criteria:

    • Known secondary hypertension
    • Type 1 diabetes mellitus
    • Has an implantable cardioverter defibrillator (ICD) or pacemaker
    • Myocardial infarction, unstable angina pectoris, syncope, or a cerebrovascular accident within 6 months of the screening period
    • Widespread atherosclerosis with documented intravascular thrombosis or unstable plaques
    • Has hemodynamically significant valvular heart disease
    • Pregnant, nursing, or planning to be pregnant
    • Any serious medical condition that may adversely affect the safety of the participant or the study
    • Currently enrolled in another investigational drug or device trial

  2. Anatomic Exclusion Criteria

    • Renal artery stenosis (≥50%) or renal artery aneurysm in either renal artery
    • History of prior renal artery intervention including balloon angioplasty or stenting
    • Multiple renal arteries where the main renal artery is estimated to supply <75% of the kidney
    • Main renal arteries with <4 mm diameter or with <20 mm treatable length (by visual estimation)
    • Renal artery abnormalities

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    renal denervation

    Arm Description

    Outcomes

    Primary Outcome Measures

    Efficacy: Reduction of systolic blood pressure(SBP) and diastolic blood pressure(DBP) at six months as measured by office-based blood pressure assessment and ambulatory blood pressure monitoring(ABPM) compared to baseline
    2.Safety: The incidence of Major Adverse Event (MAE) through 6 months , including severe renal artery dissection/stenosis(>60%)

    Secondary Outcome Measures

    Reduction in 24-h ambulatory blood pressure(ABPM) parameters
    Device or procedure related acute adverse events（Renal artery edema、mural thrombus，change in transcatheter blood pressure >20%,<20% compared to baseline、reduction of heart rate >20%）
    Symptomatic orthostatic hypotension, hypertensive emergency necessitating hospital admission
    Change in office SBP and DBP at 1, 3 months
    Change in average 24-hour SBP and DBP by ambulatory blood pressure monitoring (ABPM) at 1, 3 months
    Change in renal function at 6 months: Estimated glomerular filtration rate (eGFR) reduction >25%, 50%

    Full Information

    First Posted
    August 27, 2015
    Last Updated
    August 31, 2015
    Sponsor
    Lepu Medical Technology (Beijing) Co., Ltd.
    Collaborators
    Chinese Academy of Medical Sciences, Fuwai Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02536326
    Brief Title
    LEPU Renal Denervation System for Resistant Hypertension
    Acronym
    LEPU-RDN
    Official Title
    LEPU Renal Denervation System for Resistant Hypertension in Chinese Populations
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    November 2012 (undefined)
    Primary Completion Date
    May 2015 (Actual)
    Study Completion Date
    May 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Lepu Medical Technology (Beijing) Co., Ltd.
    Collaborators
    Chinese Academy of Medical Sciences, Fuwai Hospital

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The purpose was to evaluate 6-month outcomes of renal denervation(RDN) for the treatment of resistant hypertension in Chinese patients in a prospective cohort study.
    Detailed Description
    Currently, considerable data on RDN have been obtained from Western populations, while the clinical outcomes of RDN in East Asian populations are seldom reported. Therefore, the purpose was to evaluate 6-month outcomes of RDN for the treatment of resistant hypertension in Chinese patients.In a prospective single-center cohort study, 50 Chinese patients with resistant hypertension would be recruited to undergo RDN by LEPU Renal denervation system, which was similar to Symplicity the Symplicity renal-denervation system (Medtronic). The primary effectiveness endpoint was change in systolic and diastolic blood pressure at six months as measured by office-based blood pressure assessment and 24-hour ambulatory blood pressure monitoring following therapeutic renal denervation compared to baseline. The primary safety endpoint was the incidence of Major Adverse Event (MAE) through 6 months , including severe renal artery dissection/stenosis(>60%) that required stenting or surgery, cerebrovascular accident, myocardial infarction, death.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hypertension, Cardiovascular Diseases, Vascular Diseases

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    50 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    renal denervation
    Arm Type
    Experimental
    Intervention Type
    Device
    Intervention Name(s)
    LEPU Renal Denervation System
    Intervention Description
    LEPU Renal denervation system was similar to Symplicity Catheter System (Medtronic Inc.)
    Primary Outcome Measure Information:
    Title
    Efficacy: Reduction of systolic blood pressure(SBP) and diastolic blood pressure(DBP) at six months as measured by office-based blood pressure assessment and ambulatory blood pressure monitoring(ABPM) compared to baseline
    Time Frame
    6 months after RDN
    Title
    2.Safety: The incidence of Major Adverse Event (MAE) through 6 months , including severe renal artery dissection/stenosis(>60%)
    Time Frame
    through 6 months
    Secondary Outcome Measure Information:
    Title
    Reduction in 24-h ambulatory blood pressure(ABPM) parameters
    Time Frame
    1 month,3 months,6 months after RDN
    Title
    Device or procedure related acute adverse events（Renal artery edema、mural thrombus，change in transcatheter blood pressure >20%,<20% compared to baseline、reduction of heart rate >20%）
    Time Frame
    Perioperative period
    Title
    Symptomatic orthostatic hypotension, hypertensive emergency necessitating hospital admission
    Time Frame
    1 month,3 months,6 months after RDN
    Title
    Change in office SBP and DBP at 1, 3 months
    Time Frame
    1 month, 3 months after RDN
    Title
    Change in average 24-hour SBP and DBP by ambulatory blood pressure monitoring (ABPM) at 1, 3 months
    Time Frame
    1 month, 3 months after RDN
    Title
    Change in renal function at 6 months: Estimated glomerular filtration rate (eGFR) reduction >25%, 50%
    Time Frame
    6 months after RDN

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Age 18-65 years Stable medication regimen including ≥3 antihypertensive medications of different classes, including a diuretic (with no changes for a minimum of 4 weeks prior to RDN) 1) Office SBP and/or DBP ≥160/100 mm Hg ( ≥ 150/95 mmHg for type II diabetic patients) , 2) ABPM 24 hour mean SBP and/or DBP ≥140 and/or 90 mmHg Main renal arteries with ≥4 mm diameter or with ≥20 mm treatable length (by visual estimation) eGFR ≥45 mL/min/1.73 m2 Written informed consent Exclusion Criteria: Clinical Exclusion Criteria: Known secondary hypertension Type 1 diabetes mellitus Has an implantable cardioverter defibrillator (ICD) or pacemaker Myocardial infarction, unstable angina pectoris, syncope, or a cerebrovascular accident within 6 months of the screening period Widespread atherosclerosis with documented intravascular thrombosis or unstable plaques Has hemodynamically significant valvular heart disease Pregnant, nursing, or planning to be pregnant Any serious medical condition that may adversely affect the safety of the participant or the study Currently enrolled in another investigational drug or device trial Anatomic Exclusion Criteria Renal artery stenosis (≥50%) or renal artery aneurysm in either renal artery History of prior renal artery intervention including balloon angioplasty or stenting Multiple renal arteries where the main renal artery is estimated to supply <75% of the kidney Main renal arteries with <4 mm diameter or with <20 mm treatable length (by visual estimation) Renal artery abnormalities
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Xiongjing Jiang, Doctor
    Organizational Affiliation
    Fuwai Hospital, National Center for Cardiovascular Disease, Chinese Academy of Medical Sciences and Peking Union Medical College
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

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    LEPU Renal Denervation System for Resistant Hypertension

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