DENEX, Renal Denervation Therapy, in Patients With Hypertension on no or 1-3 Antihypertensive Medications
- Conditions
- Cardiovascular DiseasesVascular DiseasesHypertension
- Interventions
- Device: Renal Denervation
- Registration Number
- NCT04307836
- Lead Sponsor
- Kalos Medical
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 140
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description DENEX Renal denervation Renal Denervation Subjects are treated with the renal denervation procedure after randomization and maintained baseline anti-hypertensive medications
- Primary Outcome Measures
Name Time Method Changes in average daytime ambulatory systolic blood pressure at 3 months from baseline at 3 months after the procedure Changes in average daytime ambulatory systolic blood pressure from baseline at 3 months after the procedure
- Secondary Outcome Measures
Name Time Method 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 office systolic blood pressure and diastolic blood pressure from baseline at 1,3, 6 and 12 months after the procedure
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 24hr ambulatory systolic blood pressure and diastolic blood pressure from baseline at 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 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
Trial Locations
- Locations (30)
Pusan National University Hospital
🇰🇷Pusan, Korea, Republic of
Gangnam Severance Hospital, Yonsei University Health System
🇰🇷Seoul, Korea, Republic of
Seoul National University Bundang Hospital
🇰🇷Seongnam-si, Korea, Republic of
Korea University Anam Hospital
🇰🇷Seoul, Korea, Republic of
Seoul St. Mary's Hospital
🇰🇷Seoul, Korea, Republic of
Hallym University Kangnam Sacred Heart Hospital
🇰🇷Seoul, Korea, Republic of
St. Vincent's Hospital
🇰🇷Suwon, Korea, Republic of
Yeouido St.Mary's Hospital
🇰🇷Seoul, Korea, Republic of
Gachon University Gil Medical Center
🇰🇷Incheon, Korea, Republic of
Chonbuk National University Hospital
🇰🇷Jeonju, Korea, Republic of
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
Chonnam National University Hospital
🇰🇷Kwangju, Korea, Republic of
Severance Hospital, Yonsei University Health System
🇰🇷Seoul, Korea, Republic of
Hallym University Kangdong Sacred Heart Hospital
🇰🇷Seoul, Korea, Republic of
Ewha Womans University Seoul Hospital
🇰🇷Seoul, Korea, Republic of
Hanyang University Seoul Hospital
🇰🇷Seoul, Korea, Republic of
Kyung Hee University Hospital at Gangdong
🇰🇷Seoul, Korea, Republic of
St. Carollo Hospital
🇰🇷Suncheon, Korea, Republic of
Ulsan University Hospital
🇰🇷Ulsan, Korea, Republic of
Uijeongbu St.Mary's Hospital
🇰🇷Uijeongbu, Korea, Republic of
Wonju Severance Christian Hospital
🇰🇷Wŏnju, Korea, Republic of
Incheon St.Mary's Hospital
🇰🇷Incheon, Korea, Republic of
Korea University Guro Hospital
🇰🇷Seoul, Korea, Republic of
Inje University Busan Paik Hospital
🇰🇷Busan, Korea, Republic of
Bucheon St.Mary's Hospital
🇰🇷Bucheon, Korea, Republic of
Hyewon Medical Foundation Sejong General Hospital
🇰🇷Bucheon, Korea, Republic of
Inje University Ilsan Paik Hospital
🇰🇷Ilsan, Korea, Republic of
Chungbuk National University Hospital
🇰🇷Cheongju-si, Korea, Republic of
Asan Medical Center
🇰🇷Seoul, Korea, Republic of
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of