Clinical trial NCT04307836: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Hypertension
Vascular Diseases
Cardiovascular Diseases
Keywords: Hypertension
Renal Denervation
Uncontrolled hypertension
Lead sponsor: Kalos Medical
Sponsor class: INDUSTRY
First posted: 2020-03-13
Enrollment: 140
Sex: ALL
Minimum age (years): 19
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Changes in average daytime ambulatory systolic blood pressure at 3 months
timeFrame: from baseline at 3 months after the procedure
Secondary outcomes:
measure: Changes in average 24hr ambulatory systolic blood pressure and diastolic blood pressure at 3, 6 and 12 months
timeFrame: from baseline at 3, 6 and 12 months after the procedure
measure: Changes in average office systolic blood pressure and diastolic blood pressure at 1, 3, 6 and 12 months
timeFrame: from baseline at 1, 3, 6 and 12 months after the procedure
measure: Changes in average daytime and nighttime ambulatory systolic blood pressure and diastolic blood pressure at 3, 6 and 12 months
timeFrame: from baseline at 3, 6 and 12 months after the procedure
Other outcomes:
Locations:
city: Bucheon
country: Korea, Republic of
facility: Bucheon St.Mary's Hospital
city: Bucheon
country: Korea, Republic of
facility: Hyewon Medical Foundation Sejong General Hospital
city: Busan
country: Korea, Republic of
facility: Inje University Busan Paik Hospital
city: Cheongju-si
country: Korea, Republic of
facility: Chungbuk National University Hospital
city: Ilsan
country: Korea, Republic of
facility: Inje University Ilsan Paik Hospital
city: Incheon
country: Korea, Republic of
facility: Gachon University Gil Medical Center
city: Incheon
country: Korea, Republic of
facility: Incheon St.Mary's Hospital
city: Jeonju
country: Korea, Republic of
facility: Chonbuk National University Hospital
city: Kwangju
country: Korea, Republic of
facility: Chonnam National University Hospital
city: Pusan
country: Korea, Republic of
facility: Pusan National University Hospital
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University Health System
city: Seoul
country: Korea, Republic of
facility: Gangnam Severance Hospital, Yonsei University Health System
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Ewha Womans University Seoul Hospital
city: Seoul
country: Korea, Republic of
facility: Hallym University Kangdong Sacred Heart Hospital
city: Seoul
country: Korea, Republic of
facility: Hallym University Kangnam Sacred Heart Hospital
city: Seoul
country: Korea, Republic of
facility: Hanyang University Seoul Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
city: Seoul
country: Korea, Republic of
facility: Kyung Hee University Hospital at Gangdong
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul St. Mary's Hospital
city: Seoul
country: Korea, Republic of
facility: Yeouido St.Mary's Hospital
city: Suncheon
country: Korea, Republic of
facility: St. Carollo Hospital
city: Suwon
country: Korea, Republic of
facility: St. Vincent's Hospital
city: Uijeongbu
country: Korea, Republic of
facility: Uijeongbu St.Mary's Hospital
city: Ulsan
country: Korea, Republic of
facility: Ulsan University Hospital
city: Wŏnju
country: Korea, Republic of
facility: Wonju Severance Christian Hospital
Study officials:
affiliation: Seoul St. Mary's Hospital
name: Ki Yuk Chang, MD, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: