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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DENEX Renal denervation | Experimental | Subjects are treated with the renal denervation procedure after randomization and maintained baseline anti-hypertensive medications |
|
| Control group | No Intervention | Subjects are not treated with the renal denervation, not sham, after randomization and maintained baseline anti-hypertensive medications |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Renal Denervation | Device | Renal Denervation: DENEX system |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in average 24hr ambulatory systolic blood pressure and diastolic blood pressure at 3, 6 and 12 months | Changes in average 24hr ambulatory systolic blood pressure and diastolic blood pressure from baseline at 3, 6 and 12 months after the procedure | from baseline at 3, 6 and 12 months after the procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| EunHa Choi | Contact | 82-2-527-5593 | Eunha.Choi@kalosmedical.com |
| Name | Affiliation | Role |
|---|---|---|
| Ki Yuk Chang, MD, Ph.D | Seoul St. Mary's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bucheon St.Mary's Hospital | Recruiting | Bucheon-si | South Korea |
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| Changes in average office systolic blood pressure and diastolic blood pressure at 1, 3, 6 and 12 months |
Changes in average office systolic blood pressure and diastolic blood pressure from baseline at 1,3, 6 and 12 months after the procedure |
| 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 | 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 | from baseline at 3, 6 and 12 months after the procedure |
| Hyewon Medical Foundation Sejong General Hospital | Recruiting | Bucheon-si | South Korea |
|
| Inje University Busan Paik Hospital | Recruiting | Busan | South Korea |
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| Chungbuk National University Hospital | Recruiting | Cheongju-si | South Korea |
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| Inje University Ilsan Paik Hospital | Recruiting | Ilsan | South Korea |
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| Gachon University Gil Medical Center | Recruiting | Incheon | South Korea |
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| Incheon St.Mary's Hospital | Recruiting | Incheon | South Korea |
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| Chonbuk National University Hospital | Recruiting | Jeonju | South Korea |
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| Chonnam National University Hospital | Recruiting | Kwangju | South Korea |
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| Pusan National University Hospital | Recruiting | Pusan | South Korea |
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| Seoul National University Bundang Hospital | Recruiting | Seongnam-si | South Korea |
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| Korea University Anam Hospital | Recruiting | Seoul | 02841 | South Korea |
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| Seoul National University Hospital | Recruiting | Seoul | 03080 | South Korea |
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| Severance Hospital, Yonsei University Health System | Recruiting | Seoul | 03722 | South Korea |
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| Gangnam Severance Hospital, Yonsei University Health System | Recruiting | Seoul | 06273 | South Korea |
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| Asan Medical Center | Recruiting | Seoul | South Korea |
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| Ewha Womans University Seoul Hospital | Recruiting | Seoul | South Korea |
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| Hallym University Kangdong Sacred Heart Hospital | Recruiting | Seoul | South Korea |
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| Hallym University Kangnam Sacred Heart Hospital | Recruiting | Seoul | South Korea |
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| Hanyang University Seoul Hospital | Recruiting | Seoul | South Korea |
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| Korea University Guro Hospital | Recruiting | Seoul | South Korea |
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| Kyung Hee University Hospital at Gangdong | Recruiting | Seoul | South Korea |
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| Samsung Medical Center | Recruiting | Seoul | South Korea |
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| Seoul St. Mary's Hospital | Recruiting | Seoul | South Korea |
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| Yeouido St.Mary's Hospital | Recruiting | Seoul | South Korea |
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| St. Carollo Hospital | Recruiting | Suncheon | South Korea |
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| St. Vincent's Hospital | Recruiting | Suwon | South Korea |
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| Uijeongbu St.Mary's Hospital | Recruiting | Uijeongbu-si | South Korea |
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| Ulsan University Hospital | Recruiting | Ulsan | South Korea |
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| Wonju Severance Christian Hospital | Recruiting | Wŏnju | South Korea |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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