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DENEX, Renal Denervation Therapy, in Patients With Hypertension on no or 1-3 Antihypertensive Medications

Primary Purpose

Hypertension, Vascular Diseases, Cardiovascular Diseases

Status
Recruiting
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Renal Denervation
Sponsored by
Kalos Medical
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension focused on measuring Hypertension, Renal Denervation, Uncontrolled hypertension

Eligibility Criteria

19 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Subject aged 19 to 75 years old
  • Subject should maintain the 0 to 3 antihypertensive medications of different classes, ACE-I, ARB, beta blocker, CCB or diuretics, without change for at least 4 weeks of run-in period between primary screening and secondary screening and for at least 3 months after the procedure
  • Subject with 140 mmHg ≤ average office SBP < 180 mmHg and 90 mmHg ≤ office DBP < 120 mmHg at primary and secondary screening
  • Subject with 135 mmHg ≤ average daytime ambulatory SBP <170 mmHg and 85 mmHg ≤ average daytime ambulatory DBP < 105 mmHg at secondary screening after the run-in period for at least 4 weeks

Exclusion Criteria:

  • Subject with the anatomical findings in kidney or renal artery which preclude renal denervation
  • Subject with type 1 diabetes mellitus or uncontrolled type 2 diabetes mellitus
  • Subject with eGFR less than 40mL/min/1.73㎡
  • Subject with a brachial circumference greater than 42 cm.
  • Subject with secondary hypertension (except for sleep apnea patients)
  • Subject with a medical history of cerebrovascular disease or severe cardiovascular disease within 12 months prior to obtaining the consent or patients newly diagnosed with such diseases before enrollment.
  • Subject rehospitalized two or more times for hypertensive crisis within 12 months prior to obtaining consent or hospitalized for hypertensive crisis within three months prior to obtaining consent.
  • Subject with chronic oxygen therapy or mechanical ventilation (except for sleep apnea)
  • Subject with primary pulmonary hypertension

Sites / Locations

  • Bucheon St.Mary's HospitalRecruiting
  • Hyewon Medical Foundation Sejong General HospitalRecruiting
  • Inje University Busan Paik HospitalRecruiting
  • Chungbuk National University HospitalRecruiting
  • Inje University Ilsan Paik HospitalRecruiting
  • Gachon University Gil Medical CenterRecruiting
  • Incheon St.Mary's HospitalRecruiting
  • Chonbuk National University HospitalRecruiting
  • Chonnam National University HospitalRecruiting
  • Pusan National University HospitalRecruiting
  • Seoul National University Bundang HospitalRecruiting
  • Korea University Anam HospitalRecruiting
  • Seoul National University HospitalRecruiting
  • Severance Hospital, Yonsei University Health SystemRecruiting
  • Gangnam Severance Hospital, Yonsei University Health SystemRecruiting
  • Asan Medical CenterRecruiting
  • Ewha Womans University Seoul HospitalRecruiting
  • Hallym University Kangdong Sacred Heart HospitalRecruiting
  • Hallym University Kangnam Sacred Heart HospitalRecruiting
  • Hanyang University Seoul HospitalRecruiting
  • Korea University Guro HospitalRecruiting
  • Kyung Hee University Hospital at GangdongRecruiting
  • Samsung Medical CenterRecruiting
  • Seoul St. Mary's HospitalRecruiting
  • Yeouido St.Mary's HospitalRecruiting
  • St. Carollo HospitalRecruiting
  • St. Vincent's HospitalRecruiting
  • Uijeongbu St.Mary's HospitalRecruiting
  • Ulsan University HospitalRecruiting
  • Wonju Severance Christian HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

DENEX Renal denervation

Control group

Arm Description

Subjects are treated with the renal denervation procedure after randomization and maintained baseline anti-hypertensive medications

Subjects are not treated with the renal denervation, not sham, after randomization and maintained baseline anti-hypertensive medications

Outcomes

Primary Outcome Measures

Changes in average daytime ambulatory systolic blood pressure at 3 months
Changes in average daytime ambulatory systolic blood pressure from baseline at 3 months after the procedure

Secondary Outcome Measures

Changes in average 24hr ambulatory systolic blood pressure and diastolic blood pressure at 3, 6 and 12 months
Changes in average 24hr ambulatory systolic blood pressure and diastolic blood pressure from baseline at 3, 6 and 12 months after the procedure
Changes in average office systolic blood pressure and diastolic blood pressure at 1, 3, 6 and 12 months
Changes in average office systolic blood pressure and diastolic blood pressure from baseline at 1,3, 6 and 12 months after the procedure
Changes in average daytime and nighttime ambulatory systolic blood pressure and diastolic blood pressure at 3, 6 and 12 months
Changes in average daytime and nighttime ambulatory systolic blood pressure and diastolic blood pressure from baseline at 3, 6 and 12 months after the procedure

Full Information

First Posted
March 11, 2020
Last Updated
October 4, 2023
Sponsor
Kalos Medical
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1. Study Identification

Unique Protocol Identification Number
NCT04307836
Brief Title
DENEX, Renal Denervation Therapy, in Patients With Hypertension on no or 1-3 Antihypertensive Medications
Official Title
A Prospective, Multicenter, No-treatment Controlled, Randomized, Open-label, Pivotal Study to Evaluate the Safety and Efficacy of DENEX, Renal Denervation Therapy, in Patients With Hypertension on no or 1-3 Antihypertensive Medications
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 9, 2020 (Actual)
Primary Completion Date
July 17, 2023 (Actual)
Study Completion Date
April 17, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kalos Medical

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The objective of this study is to show that the safety and efficacy of renal denervation using DENEX, are superior to those of control group for the patients with hypertension on no or 1 to 3 antihypertensive medications.
Detailed Description
DENEX system developed by Handok Kalos Medical Inc. is a renal denervation system to efficiently block the sympathetic nerve of the kidney with minimal invasive procedure. It was developed to block the sympathetic nerves distributed in blood vessel wall by delivering high frequency energy to the renal artery for the purpose of treating hypertension.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Vascular Diseases, Cardiovascular Diseases
Keywords
Hypertension, Renal Denervation, Uncontrolled hypertension

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
140 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
DENEX Renal denervation
Arm Type
Experimental
Arm Description
Subjects are treated with the renal denervation procedure after randomization and maintained baseline anti-hypertensive medications
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Subjects are not treated with the renal denervation, not sham, after randomization and maintained baseline anti-hypertensive medications
Intervention Type
Device
Intervention Name(s)
Renal Denervation
Intervention Description
Renal Denervation: DENEX system
Primary Outcome Measure Information:
Title
Changes in average daytime ambulatory systolic blood pressure at 3 months
Description
Changes in average daytime ambulatory systolic blood pressure from baseline at 3 months after the procedure
Time Frame
from baseline at 3 months after the procedure
Secondary Outcome Measure Information:
Title
Changes in average 24hr ambulatory systolic blood pressure and diastolic blood pressure at 3, 6 and 12 months
Description
Changes in average 24hr ambulatory systolic blood pressure and diastolic blood pressure from baseline at 3, 6 and 12 months after the procedure
Time Frame
from baseline at 3, 6 and 12 months after the procedure
Title
Changes in average office systolic blood pressure and diastolic blood pressure at 1, 3, 6 and 12 months
Description
Changes in average office systolic blood pressure and diastolic blood pressure from baseline at 1,3, 6 and 12 months after the procedure
Time Frame
from baseline at 1, 3, 6 and 12 months after the procedure
Title
Changes in average daytime and nighttime ambulatory systolic blood pressure and diastolic blood pressure at 3, 6 and 12 months
Description
Changes in average daytime and nighttime ambulatory systolic blood pressure and diastolic blood pressure from baseline at 3, 6 and 12 months after the procedure
Time Frame
from baseline at 3, 6 and 12 months after the procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subject aged 19 to 75 years old Subject should maintain the 0 to 3 antihypertensive medications of different classes, ACE-I, ARB, beta blocker, CCB or diuretics, without change for at least 4 weeks of run-in period between primary screening and secondary screening and for at least 3 months after the procedure Subject with 140 mmHg ≤ average office SBP < 180 mmHg and 90 mmHg ≤ office DBP < 120 mmHg at primary and secondary screening Subject with 135 mmHg ≤ average daytime ambulatory SBP <170 mmHg and 85 mmHg ≤ average daytime ambulatory DBP < 105 mmHg at secondary screening after the run-in period for at least 4 weeks Exclusion Criteria: Subject with the anatomical findings in kidney or renal artery which preclude renal denervation Subject with type 1 diabetes mellitus or uncontrolled type 2 diabetes mellitus Subject with eGFR less than 40mL/min/1.73㎡ Subject with a brachial circumference greater than 42 cm. Subject with secondary hypertension (except for sleep apnea patients) Subject with a medical history of cerebrovascular disease or severe cardiovascular disease within 12 months prior to obtaining the consent or patients newly diagnosed with such diseases before enrollment. Subject rehospitalized two or more times for hypertensive crisis within 12 months prior to obtaining consent or hospitalized for hypertensive crisis within three months prior to obtaining consent. Subject with chronic oxygen therapy or mechanical ventilation (except for sleep apnea) Subject with primary pulmonary hypertension
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
EunHa Choi
Phone
82-2-527-5593
Email
Eunha.Choi@kalosmedical.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ki Yuk Chang, MD, Ph.D
Organizational Affiliation
Seoul St. Mary's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bucheon St.Mary's Hospital
City
Bucheon
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sang Hyun Ihm, MD
Facility Name
Hyewon Medical Foundation Sejong General Hospital
City
Bucheon
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Young Jin Choi, MD
Facility Name
Inje University Busan Paik Hospital
City
Busan
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tae Hyun Yang, MD
Facility Name
Chungbuk National University Hospital
City
Cheongju-si
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jang Whan Bae, MD
Facility Name
Inje University Ilsan Paik Hospital
City
Ilsan
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sang Yun Lee, MD
Facility Name
Gachon University Gil Medical Center
City
Incheon
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Woong Chol Kang, MD
Facility Name
Incheon St.Mary's Hospital
City
Incheon
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ik Jun Choi, MD
Facility Name
Chonbuk National University Hospital
City
Jeonju
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sang Rok Lee, MD
Facility Name
Chonnam National University Hospital
City
Kwangju
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ju Han Kim, MD
Facility Name
Pusan National University Hospital
City
Pusan
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Han Cheol Lee, MD
Facility Name
Seoul National University Bundang Hospital
City
Seongnam-si
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dong Ju Choi, MD
Facility Name
Korea University Anam Hospital
City
Seoul
ZIP/Postal Code
02841
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Soon Jun Hong, MD
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hae-young Lee, MD
Facility Name
Severance Hospital, Yonsei University Health System
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Byeong-Keuk Kim, MD
Facility Name
Gangnam Severance Hospital, Yonsei University Health System
City
Seoul
ZIP/Postal Code
06273
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Young Won Yoon, MD
Facility Name
Asan Medical Center
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pil Hyung Lee, MD
Facility Name
Ewha Womans University Seoul Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wook Bum Pyun, MD
Facility Name
Hallym University Kangdong Sacred Heart Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jun Hee Lee, MD
Facility Name
Hallym University Kangnam Sacred Heart Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jung-Rae Cho, MD
Facility Name
Hanyang University Seoul Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jin Ho Shin, MD
Facility Name
Korea University Guro Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cheol Ung Choi, MD
Facility Name
Kyung Hee University Hospital at Gangdong
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jin Man Cho, MD
Facility Name
Samsung Medical Center
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Seung Hyuk Choi, MD
Facility Name
Seoul St. Mary's Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ki Yuk Chang, MD
Facility Name
Yeouido St.Mary's Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chul Soo Park, MD
Facility Name
St. Carollo Hospital
City
Suncheon
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jang Hyun Cho, MD
Facility Name
St. Vincent's Hospital
City
Suwon
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ki Dong Yoo, MD
Facility Name
Uijeongbu St.Mary's Hospital
City
Uijeongbu
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chan Joon Kim, MD
Facility Name
Ulsan University Hospital
City
Ulsan
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eun-Seok Shin, MD
Facility Name
Wonju Severance Christian Hospital
City
Wŏnju
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
SungGyun Ahn, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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DENEX, Renal Denervation Therapy, in Patients With Hypertension on no or 1-3 Antihypertensive Medications

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