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

LEPU Renal Denervation System for Resistant Hypertension in Chinese Populations

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.

Study Overview

• Status: Completed
• Conditions: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Intervention / Treatment: Device: LEPU Renal Denervation System

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.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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	6 months after RDN
2.Safety: The incidence of Major Adverse Event (MAE) through 6 months , including severe renal artery dissection/stenosis(>60%)	through 6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Reduction in 24-h ambulatory blood pressure(ABPM) parameters	1 month,3 months,6 months after RDN
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%）	Perioperative period
Symptomatic orthostatic hypotension, hypertensive emergency necessitating hospital admission	1 month,3 months,6 months after RDN
Change in office SBP and DBP at 1, 3 months	1 month, 3 months after RDN
Change in average 24-hour SBP and DBP by ambulatory blood pressure monitoring (ABPM) at 1, 3 months	1 month, 3 months after RDN
Change in renal function at 6 months: Estimated glomerular filtration rate (eGFR) reduction >25%, 50%	6 months after RDN

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start: November 1, 2012
• Primary Completion (Actual): May 1, 2015
• Study Completion (Actual): May 1, 2015

Study Registration Dates

• First Submitted: August 27, 2015
• First Submitted That Met QC Criteria: August 27, 2015
• First Posted (Estimate): August 31, 2015

Study Record Updates

• Last Update Posted (Estimate): September 2, 2015
• Last Update Submitted That Met QC Criteria: August 31, 2015
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hypertension; Cardiovascular Diseases; Vascular Diseases
• Other Study ID Numbers: 2012-ZX-028