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
1 other identifier
interventional
140
1 country
30
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable hypertension
Started Jul 2020
Longer than P75 for not_applicable hypertension
30 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 11, 2020
CompletedFirst Posted
Study publicly available on registry
March 13, 2020
CompletedStudy Start
First participant enrolled
July 9, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 17, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
April 17, 2024
CompletedOctober 6, 2023
February 1, 2023
3 years
March 11, 2020
October 4, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
Changes in average 24hr ambulatory systolic blood pressure and diastolic blood pressure at 3, 6 and 12 months
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
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
from baseline at 3, 6 and 12 months after the procedure
Study Arms (2)
DENEX Renal denervation
EXPERIMENTALSubjects are treated with the renal denervation procedure after randomization and maintained baseline anti-hypertensive medications
Control group
NO INTERVENTIONSubjects are not treated with the renal denervation, not sham, after randomization and maintained baseline anti-hypertensive medications
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Kalos Medicallead
Study Sites (30)
Bucheon St.Mary's Hospital
Bucheon-si, South Korea
Hyewon Medical Foundation Sejong General Hospital
Bucheon-si, South Korea
Inje University Busan Paik Hospital
Busan, South Korea
Chungbuk National University Hospital
Cheongju-si, South Korea
Inje University Ilsan Paik Hospital
Ilsan, South Korea
Gachon University Gil Medical Center
Incheon, South Korea
Incheon St.Mary's Hospital
Incheon, South Korea
Chonbuk National University Hospital
Jeonju, South Korea
Chonnam National University Hospital
Kwangju, South Korea
Pusan National University Hospital
Pusan, South Korea
Seoul National University Bundang Hospital
Seongnam-si, South Korea
Korea University Anam Hospital
Seoul, 02841, South Korea
Seoul National University Hospital
Seoul, 03080, South Korea
Severance Hospital, Yonsei University Health System
Seoul, 03722, South Korea
Gangnam Severance Hospital, Yonsei University Health System
Seoul, 06273, South Korea
Asan Medical Center
Seoul, South Korea
Ewha Womans University Seoul Hospital
Seoul, South Korea
Hallym University Kangdong Sacred Heart Hospital
Seoul, South Korea
Hallym University Kangnam Sacred Heart Hospital
Seoul, South Korea
Hanyang University Seoul Hospital
Seoul, South Korea
Korea University Guro Hospital
Seoul, South Korea
Kyung Hee University Hospital at Gangdong
Seoul, South Korea
Samsung Medical Center
Seoul, South Korea
Seoul St. Mary's Hospital
Seoul, South Korea
Yeouido St.Mary's Hospital
Seoul, South Korea
St. Carollo Hospital
Suncheon, South Korea
St. Vincent's Hospital
Suwon, South Korea
Uijeongbu St.Mary's Hospital
Uijeongbu-si, South Korea
Ulsan University Hospital
Ulsan, South Korea
Wonju Severance Christian Hospital
Wŏnju, South Korea
MeSH Terms
Conditions
Study Officials
- PRINCIPAL INVESTIGATOR
Ki Yuk Chang, MD, Ph.D
Seoul St. Mary's Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 11, 2020
First Posted
March 13, 2020
Study Start
July 9, 2020
Primary Completion
July 17, 2023
Study Completion
April 17, 2024
Last Updated
October 6, 2023
Record last verified: 2023-02
Data Sharing
- IPD Sharing
- Will not share