NCT02536326

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at below P25 for phase_3 hypertension

Timeline
Completed

Started Nov 2012

Typical duration for phase_3 hypertension

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2012

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 27, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 31, 2015

Completed
Last Updated

September 2, 2015

Status Verified

August 1, 2015

Enrollment Period

2.5 years

First QC Date

August 27, 2015

Last Update Submit

August 31, 2015

Conditions

HypertensionCardiovascular DiseasesVascular Diseases

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (6)

  • 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

  • +1 more secondary outcomes

Study Arms (1)

renal denervation

EXPERIMENTAL
Device: LEPU Renal Denervation System

Interventions

LEPU Renal Denervation SystemDEVICE

LEPU Renal denervation system was similar to Symplicity Catheter System (Medtronic Inc.)

renal denervation

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)
  • \) 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

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

HypertensionCardiovascular DiseasesVascular Diseases

Study Officials

  • Xiongjing Jiang, Doctor

    Fuwai Hospital, National Center for Cardiovascular Disease, Chinese Academy of Medical Sciences and Peking Union Medical College

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 27, 2015

First Posted

August 31, 2015

Study Start

November 1, 2012

Primary Completion

May 1, 2015

Study Completion

May 1, 2015

Last Updated

September 2, 2015

Record last verified: 2015-08