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

Last updated: October 4, 2023
Sponsor: Kalos Medical
Overall Status: Active - Recruiting

Phase

N/A

Condition

Vascular Diseases

Stress

Williams Syndrome

Treatment

Renal Denervation

Clinical Study ID

NCT04307836
DN_P101
  • Ages 19-75
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 ofrun-in period between primary screening and secondary screening and for at least 3months after the procedure
  • Subject with 140 mmHg ≤ average office SBP < 180 mmHg and 90 mmHg ≤ office DBP < 120mmHg at primary and secondary screening
  • Subject with 135 mmHg ≤ average daytime ambulatory SBP <170 mmHg and 85 mmHg ≤ averagedaytime ambulatory DBP < 105 mmHg at secondary screening after the run-in period forat least 4 weeks

Exclusion

Exclusion Criteria:

  • Subject with the anatomical findings in kidney or renal artery which preclude renaldenervation
  • 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 cardiovasculardisease within 12 months prior to obtaining the consent or patients newly diagnosedwith such diseases before enrollment.
  • Subject rehospitalized two or more times for hypertensive crisis within 12 monthsprior to obtaining consent or hospitalized for hypertensive crisis within three monthsprior to obtaining consent.
  • Subject with chronic oxygen therapy or mechanical ventilation (except for sleep apnea)
  • Subject with primary pulmonary hypertension

Study Design

Total Participants: 140
Treatment Group(s): 1
Primary Treatment: Renal Denervation
Phase:
Study Start date:
July 09, 2020
Estimated Completion Date:
April 17, 2024

Study 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.

Connect with a study center

  • Bucheon St.Mary's Hospital

    Bucheon,
    Korea, Republic of

    Active - Recruiting

  • Hyewon Medical Foundation Sejong General Hospital

    Bucheon,
    Korea, Republic of

    Active - Recruiting

  • Inje University Busan Paik Hospital

    Busan,
    Korea, Republic of

    Active - Recruiting

  • Chungbuk National University Hospital

    Cheongju-si,
    Korea, Republic of

    Active - Recruiting

  • Inje University Ilsan Paik Hospital

    Ilsan,
    Korea, Republic of

    Active - Recruiting

  • Gachon University Gil Medical Center

    Incheon,
    Korea, Republic of

    Active - Recruiting

  • Incheon St.Mary's Hospital

    Incheon,
    Korea, Republic of

    Active - Recruiting

  • Chonbuk National University Hospital

    Jeonju,
    Korea, Republic of

    Active - Recruiting

  • Chonnam National University Hospital

    Kwangju,
    Korea, Republic of

    Active - Recruiting

  • Pusan National University Hospital

    Pusan,
    Korea, Republic of

    Active - Recruiting

  • Seoul National University Bundang Hospital

    Seongnam-si,
    Korea, Republic of

    Active - Recruiting

  • Asan Medical Center

    Seoul,
    Korea, Republic of

    Active - Recruiting

  • Ewha Womans University Seoul Hospital

    Seoul,
    Korea, Republic of

    Active - Recruiting

  • Gangnam Severance Hospital, Yonsei University Health System

    Seoul, 06273
    Korea, Republic of

    Active - Recruiting

  • Hallym University Kangdong Sacred Heart Hospital

    Seoul,
    Korea, Republic of

    Active - Recruiting

  • Hallym University Kangnam Sacred Heart Hospital

    Seoul,
    Korea, Republic of

    Active - Recruiting

  • Hanyang University Seoul Hospital

    Seoul,
    Korea, Republic of

    Active - Recruiting

  • Korea University Anam Hospital

    Seoul, 02841
    Korea, Republic of

    Active - Recruiting

  • Korea University Guro Hospital

    Seoul,
    Korea, Republic of

    Active - Recruiting

  • Kyung Hee University Hospital at Gangdong

    Seoul,
    Korea, Republic of

    Active - Recruiting

  • Samsung Medical Center

    Seoul,
    Korea, Republic of

    Active - Recruiting

  • Seoul National University Hospital

    Seoul, 03080
    Korea, Republic of

    Active - Recruiting

  • Seoul St. Mary's Hospital

    Seoul,
    Korea, Republic of

    Active - Recruiting

  • Severance Hospital, Yonsei University Health System

    Seoul, 03722
    Korea, Republic of

    Active - Recruiting

  • Yeouido St.Mary's Hospital

    Seoul,
    Korea, Republic of

    Active - Recruiting

  • St. Carollo Hospital

    Suncheon,
    Korea, Republic of

    Active - Recruiting

  • St. Vincent's Hospital

    Suwon,
    Korea, Republic of

    Active - Recruiting

  • Uijeongbu St.Mary's Hospital

    Uijeongbu,
    Korea, Republic of

    Active - Recruiting

  • Ulsan University Hospital

    Ulsan,
    Korea, Republic of

    Active - Recruiting

  • Wonju Severance Christian Hospital

    Wŏnju,
    Korea, Republic of

    Active - Recruiting

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