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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Intervention / Treatment: Device: Renal Denervation

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.

• Study Type: Interventional
• Enrollment (Estimated): 140
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: EunHa Choi; Phone Number: 82-2-527-5593; Email: Eunha.Choi@kalosmedical.com

Study Locations

• Korea, Republic of
  • Bucheon, Korea, Republic of
    • Recruiting
    • Bucheon St.Mary's Hospital
    • Contact: Sang Hyun Ihm, MD
  • Bucheon, Korea, Republic of
    • Recruiting
    • Hyewon Medical Foundation Sejong General Hospital
    • Contact: Young Jin Choi, MD
  • Busan, Korea, Republic of
    • Recruiting
    • Inje University Busan Paik Hospital
    • Contact: Tae Hyun Yang, MD
  • Cheongju-si, Korea, Republic of
    • Recruiting
    • Chungbuk National University Hospital
    • Contact: Jang Whan Bae, MD
  • Ilsan, Korea, Republic of
    • Recruiting
    • Inje University Ilsan Paik Hospital
    • Contact: Sang Yun Lee, MD
  • Incheon, Korea, Republic of
    • Recruiting
    • Gachon University Gil Medical Center
    • Contact: Woong Chol Kang, MD
  • Incheon, Korea, Republic of
    • Recruiting
    • Incheon St.Mary's Hospital
    • Contact: Ik Jun Choi, MD
  • Jeonju, Korea, Republic of
    • Recruiting
    • Chonbuk National University Hospital
    • Contact: Sang Rok Lee, MD
  • Kwangju, Korea, Republic of
    • Recruiting
    • Chonnam National University Hospital
    • Contact: Ju Han Kim, MD
  • Pusan, Korea, Republic of
    • Recruiting
    • Pusan National University Hospital
    • Contact: Han Cheol Lee, MD
  • Seongnam-si, Korea, Republic of
    • Recruiting
    • Seoul National University Bundang Hospital
    • Contact: Dong Ju Choi, MD
  • Seoul, Korea, Republic of
    • Recruiting
    • Asan Medical Center
    • Contact: Pil Hyung Lee, MD
  • Seoul, Korea, Republic of, 03080
    • Recruiting
    • Seoul National University Hospital
    • Contact: Hae-young Lee, MD
  • Seoul, Korea, Republic of, 03722
    • Recruiting
    • Severance Hospital, Yonsei University Health System
    • Contact: Byeong-Keuk Kim, MD
  • Seoul, Korea, Republic of
    • Recruiting
    • Samsung Medical Center
    • Contact: Seung Hyuk Choi, MD
  • Seoul, Korea, Republic of, 06273
    • Recruiting
    • Gangnam Severance Hospital, Yonsei University Health System
    • Contact: Young Won Yoon, MD
  • Seoul, Korea, Republic of
    • Recruiting
    • Seoul st. mary's hospital
    • Contact: Ki Yuk Chang, MD
  • Seoul, Korea, Republic of, 02841
    • Recruiting
    • Korea University Anam Hospital
    • Contact: Soon Jun Hong, MD
  • Seoul, Korea, Republic of
    • Recruiting
    • Korea University Guro Hospital
    • Contact: Cheol Ung Choi, MD
  • Seoul, Korea, Republic of
    • Recruiting
    • Hallym University Kangdong Sacred Heart Hospital
    • Contact: Jun Hee Lee, MD
  • Seoul, Korea, Republic of
    • Recruiting
    • Hanyang University Seoul Hospital
    • Contact: Jin Ho Shin, MD
  • Seoul, Korea, Republic of
    • Recruiting
    • Kyung Hee University Hospital at Gangdong
    • Contact: Jin Man Cho, MD
  • Seoul, Korea, Republic of
    • Recruiting
    • Hallym University Kangnam Sacred Heart Hospital
    • Contact: Jung-rae Cho, MD
  • Seoul, Korea, Republic of
    • Recruiting
    • Ewha Womans University Seoul Hospital
    • Contact: Wook Bum Pyun, MD
  • Seoul, Korea, Republic of
    • Recruiting
    • Yeouido St.Mary's Hospital
    • Contact: Chul Soo Park, MD
  • Suncheon, Korea, Republic of
    • Recruiting
    • St. Carollo Hospital
    • Contact: Jang Hyun Cho, MD
  • Suwon, Korea, Republic of
    • Recruiting
    • St. Vincent's Hospital
    • Contact: Ki Dong Yoo, MD
  • Uijeongbu, Korea, Republic of
    • Recruiting
    • Uijeongbu St.Mary's Hospital
    • Contact: Chan Joon Kim, MD
  • Ulsan, Korea, Republic of
    • Recruiting
    • Ulsan University Hospital
    • Contact: Eun-seok Shin, MD
  • Wŏnju, Korea, Republic of
    • Recruiting
    • Wonju Severance Christian Hospital
    • Contact: SungGyun Ahn, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: DENEX Renal denervation; Subjects are treated with the renal denervation procedure after randomization and maintained baseline anti-hypertensive medications	Device: Renal Denervation; Renal Denervation: DENEX system
No Intervention: Control group; Subjects are not treated with the renal denervation, not sham, after randomization and maintained baseline anti-hypertensive medications

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	from baseline at 3 months after the procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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	from baseline at 3, 6 and 12 months after the procedure

Collaborators and Investigators

• Sponsor: Kalos Medical
• Investigators: Principal Investigator: Ki Yuk Chang, MD, Ph.D, Seoul st. mary's hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 9, 2020
• Primary Completion (Actual): July 17, 2023
• Study Completion (Estimated): April 17, 2024

Study Registration Dates

• First Submitted: March 11, 2020
• First Submitted That Met QC Criteria: March 11, 2020
• First Posted (Actual): March 13, 2020

Study Record Updates

• Last Update Posted (Actual): October 6, 2023
• Last Update Submitted That Met QC Criteria: October 4, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Hypertension; Uncontrolled hypertension; Renal Denervation
• Additional Relevant MeSH Terms: Hypertension; Cardiovascular Diseases; Vascular Diseases
• Other Study ID Numbers: DN_P101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No