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

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ClinicalTrials.gov Identifier: NCT02536326
Recruitment Status : Completed
First Posted : August 31, 2015
Last Update Posted : September 2, 2015
Sponsor:
Collaborator:
Chinese Academy of Medical Sciences, Fuwai Hospital
Information provided by (Responsible Party):
Lepu Medical Technology (Beijing) Co., Ltd.

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.

Condition or disease Intervention/treatment Phase
Hypertension Cardiovascular Diseases Vascular Diseases Device: LEPU Renal Denervation System Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: LEPU Renal Denervation System for Resistant Hypertension in Chinese Populations
Study Start Date : November 2012
Actual Primary Completion Date : May 2015
Actual Study Completion Date : May 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: renal denervation Device: LEPU Renal Denervation System
LEPU Renal denervation system was similar to Symplicity Catheter System (Medtronic Inc.)




Primary Outcome Measures :
  1. 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 ]
  2. 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 Measures :
  1. Reduction in 24-h ambulatory blood pressure(ABPM) parameters [ Time Frame: 1 month,3 months,6 months after RDN ]
  2. 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 ]
  3. Symptomatic orthostatic hypotension, hypertensive emergency necessitating hospital admission [ Time Frame: 1 month,3 months,6 months after RDN ]
  4. Change in office SBP and DBP at 1, 3 months [ Time Frame: 1 month, 3 months after RDN ]
  5. 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 ]
  6. Change in renal function at 6 months: Estimated glomerular filtration rate (eGFR) reduction >25%, 50% [ Time Frame: 6 months after RDN ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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:

  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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02536326


Sponsors and Collaborators
Lepu Medical Technology (Beijing) Co., Ltd.
Chinese Academy of Medical Sciences, Fuwai Hospital
Investigators
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Principal Investigator: Xiongjing Jiang, Doctor Fuwai Hospital, National Center for Cardiovascular Disease, Chinese Academy of Medical Sciences and Peking Union Medical College

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Responsible Party: Lepu Medical Technology (Beijing) Co., Ltd.
ClinicalTrials.gov Identifier: NCT02536326     History of Changes
Other Study ID Numbers: 2012-ZX-028
First Posted: August 31, 2015    Key Record Dates
Last Update Posted: September 2, 2015
Last Verified: August 2015
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases