DENEX, Renal Denervation Therapy, in Patients With Hypertension on no or 1-3 Antihypertensive Medications
NCT ID: NCT04307836
Last Updated: 2023-10-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
140 participants
INTERVENTIONAL
2020-07-09
2024-04-17
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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DENEX Renal denervation
Subjects are treated with the renal denervation procedure after randomization and maintained baseline anti-hypertensive medications
Renal Denervation
Renal Denervation: DENEX system
Control group
Subjects are not treated with the renal denervation, not sham, after randomization and maintained baseline anti-hypertensive medications
No interventions assigned to this group
Interventions
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Renal Denervation
Renal Denervation: DENEX system
Eligibility Criteria
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Inclusion Criteria
* 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 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
19 Years
75 Years
ALL
No
Sponsors
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Kalos Medical
INDUSTRY
Responsible Party
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Principal Investigators
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Ki Yuk Chang, MD, Ph.D
Role: PRINCIPAL_INVESTIGATOR
Seoul St. Mary's Hospital
Locations
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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, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Severance Hospital, Yonsei University Health System
Seoul, , South Korea
Gangnam Severance Hospital, Yonsei University Health System
Seoul, , 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
Countries
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Central Contacts
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Facility Contacts
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Sang Hyun Ihm, MD
Role: primary
Young Jin Choi, MD
Role: primary
Tae Hyun Yang, MD
Role: primary
Jang Whan Bae, MD
Role: primary
Sang Yun Lee, MD
Role: primary
Woong Chol Kang, MD
Role: primary
Ik Jun Choi, MD
Role: primary
Sang Rok Lee, MD
Role: primary
Ju Han Kim, MD
Role: primary
Han Cheol Lee, MD
Role: primary
Dong Ju Choi, MD
Role: primary
Soon Jun Hong, MD
Role: primary
Hae-young Lee, MD
Role: primary
Byeong-Keuk Kim, MD
Role: primary
Young Won Yoon, MD
Role: primary
Pil Hyung Lee, MD
Role: primary
Wook Bum Pyun, MD
Role: primary
Jun Hee Lee, MD
Role: primary
Jung-Rae Cho, MD
Role: primary
Jin Ho Shin, MD
Role: primary
Cheol Ung Choi, MD
Role: primary
Jin Man Cho, MD
Role: primary
Seung Hyuk Choi, MD
Role: primary
Ki Yuk Chang, MD
Role: primary
Chul Soo Park, MD
Role: primary
Jang Hyun Cho, MD
Role: primary
Ki Dong Yoo, MD
Role: primary
Chan Joon Kim, MD
Role: primary
Eun-Seok Shin, MD
Role: primary
SungGyun Ahn, MD
Role: primary
Other Identifiers
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DN_P101
Identifier Type: -
Identifier Source: org_study_id
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