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An Open-label, Single-arm, Multicenter Feasibility Study Evaluating the Safety of Catheter-based Renal Denervation with DENEX™ in Patients with Uncontrolled Hypertension on Standard Medical Therapy
DC Field | Value | Language |
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dc.contributor.author | 김병극 | - |
dc.contributor.author | 장양수 | - |
dc.date.accessioned | 2022-09-14T01:12:32Z | - |
dc.date.available | 2022-09-14T01:12:32Z | - |
dc.date.issued | 2021-01 | - |
dc.identifier.issn | 1738-5520 | - |
dc.identifier.uri | https://ir.ymlib.yonsei.ac.kr/handle/22282913/190342 | - |
dc.description.abstract | Background and objectives: DENEX™ is a novel renal sympathetic denervation (RDN) system that is equipped with 3 electrodes that deliver radiofrequency energy to the renal nerves along renal arteries. The purpose of this study was to evaluate the safety and efficacy of RDN with DENEX™ in resistant hypertension. Methods: This was an open-label, single-arm, multicenter, first-in-man pilot study. Between November 2016 and May 2018, a total of 16 patients were enrolled at 4 centers in South Korea. The inclusion criteria were systolic blood pressure (SBP) ≥150 mmHg and use of 3 or more antihypertensive medications, including diuretics. The primary objective was the safety outcome of RDN with the DENEX™ system. The secondary objective was efficacy outcome based on changes of office, and 24-hour ambulatory SBP from baseline to 3 months. The patients underwent abdominal computed tomography (CT) or duplex ultrasonogram before and 6 months after RDN. Results: No major adverse events occurred after RDN for 6 month of follow-up period. There was no vascular complication either by CT or duplex ultrasonogram. The office SBP was significantly reduced from 164.6±11.6 mmHg at baseline to 142.0±20.4 mmHg (-24.4±24.4 mmHg, p=0.003) at 3 months. The ambulatory SBP was reduced from 151.44±12.85 mmHg at baseline to 140.0±16.5 mmHg (-13.1±18.9 mmHg, p=0.056) at 3 months. Conclusion: RDN with the DENEX™ system showed a favorable safety profile in resistant hypertension. A significant reduction in office SBP and a borderline reduction in ambulatory SBP were observed. Trial registration: ClinicalTrials.gov Identifier: NCT04248530. | - |
dc.description.statementOfResponsibility | open | - |
dc.language | English, Korean | - |
dc.publisher | Korean Society of Circulation | - |
dc.relation.isPartOf | KOREAN CIRCULATION JOURNAL | - |
dc.rights | CC BY-NC-ND 2.0 KR | - |
dc.title | An Open-label, Single-arm, Multicenter Feasibility Study Evaluating the Safety of Catheter-based Renal Denervation with DENEX™ in Patients with Uncontrolled Hypertension on Standard Medical Therapy | - |
dc.type | Article | - |
dc.contributor.college | College of Medicine (의과대학) | - |
dc.contributor.department | Dept. of Internal Medicine (내과학교실) | - |
dc.contributor.googleauthor | Chan Joon Kim | - |
dc.contributor.googleauthor | Kiyuk Chang | - |
dc.contributor.googleauthor | Byeong Keuk Kim | - |
dc.contributor.googleauthor | Chang Gyu Park | - |
dc.contributor.googleauthor | Yangsoo Jang | - |
dc.identifier.doi | 10.4070/kcj.2020.0391 | - |
dc.contributor.localId | A00493 | - |
dc.contributor.localId | A03448 | - |
dc.relation.journalcode | J01952 | - |
dc.identifier.eissn | 1738-5555 | - |
dc.identifier.pmid | 33377328 | - |
dc.subject.keyword | Catheter ablation | - |
dc.subject.keyword | Denervation | - |
dc.subject.keyword | Drug resistance | - |
dc.subject.keyword | Hypertension | - |
dc.contributor.alternativeName | Kim, Byeong Keuk | - |
dc.contributor.affiliatedAuthor | 김병극 | - |
dc.contributor.affiliatedAuthor | 장양수 | - |
dc.citation.volume | 51 | - |
dc.citation.number | 1 | - |
dc.citation.startPage | 43 | - |
dc.citation.endPage | 55 | - |
dc.identifier.bibliographicCitation | KOREAN CIRCULATION JOURNAL, Vol.51(1) : 43-55, 2021-01 | - |
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