LEPU Renal Denervation System for Resistant Hypertension

Hypertension Clinical Trial

— LEPU-RDN  

Official title:

LEPU Renal Denervation System for Resistant Hypertension in Chinese Populations

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02536326
• Other study ID #: 2012-ZX-028
• Status: Completed
• Phase: Phase 3
• First received: August 27, 2015
• Last updated: August 31, 2015
• Start date: November 2012
• Est. completion date: May 2015

Study information

• Verified date: August 2015
• Source: Lepu Medical Technology (Beijing) Co.,Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Hypertension
• Vascular Diseases

Intervention

Device:
• LEPU Renal Denervation System
LEPU Renal denervation system was similar to Symplicity Catheter System (Medtronic Inc.)

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Lepu Medical Technology (Beijing) Co.,Ltd	Chinese Academy of Medical Sciences, Fuwai Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	2.Safety: The incidence of Major Adverse Event (MAE) through 6 months , including severe renal artery dissection/stenosis(>60%)		through 6 months	Yes
Secondary	Reduction in 24-h ambulatory blood pressure(ABPM) parameters		1 month,3 months,6 months after RDN	No
Secondary	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	Yes
Secondary	Symptomatic orthostatic hypotension, hypertensive emergency necessitating hospital admission		1 month,3 months,6 months after RDN	Yes
Secondary	Change in office SBP and DBP at 1, 3 months		1 month, 3 months after RDN	No
Secondary	Change in average 24-hour SBP and DBP by ambulatory blood pressure monitoring (ABPM) at 1, 3 months		1 month, 3 months after RDN	No
Secondary	Change in renal function at 6 months: Estimated glomerular filtration rate (eGFR) reduction >25%, 50%		6 months after RDN	Yes