Evidence map›Paper›PMID 33377328›Full record

ArticleKorean circulation journal2021

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.

Chan Joon Kim, Kiyuk Chang, Byeong Keuk Kim, Chang Gyu Park, Yangsoo Jang

Registry-linked trialAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Korean circulation journal, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04248530 (An Open-Label, Single Arm, Multicenter Feasibility Study to Evaluate the Safety of Catheter-Based Renal Denervation With the DENEX System in Patients With Uncontrolled Hypertension on Standard Medical Therapy), which is not on this map. Cited by 5 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04248530 nacompletednot on this map

An Open-Label, Single Arm, Multicenter Feasibility Study to Evaluate the Safety of Catheter-Based Renal Denervation With the DENEX System in Patients With Uncontrolled Hypertension on Standard Medical Therapy

TypeinterventionalSponsorKalos MedicalRan2016 to 2020Enrolled16ConditionsUncontrolled HypertensionArmsRenal denervation
3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Article
  3. Review
  4. Renal Denervation, Come Back Time?Korean circulation journal · 2021
    Article
  5. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors.

Chan Joon KimDivision of Cardiology, Department of Internal Medicine, Uijeongbu St. Mary's Hospital, The Catholic University of Korea College of Medicine, Uijeongbu, Korea.ORCID https://orcid.org/0000-0003-2929-8325
Kiyuk ChangDepartment of Cardiology, Seoul St. Mary's Hospital, The Catholic University of Korea College of Medicine, Seoul, Korea.ORCID https://orcid.org/0000-0003-3456-8705
Byeong Keuk KimSeverance Cardiovascular Hospital, Yonsei University College of Medicine, Seoul, Korea.ORCID https://orcid.org/0000-0003-2493-066X
Chang Gyu ParkCardiovascular Center, Korea University Guro Hospital, Korea University College of Medicine, Seoul, Korea.ORCID https://orcid.org/0000-0001-9654-9257
Yangsoo JangSeverance Cardiovascular Hospital, Yonsei University College of Medicine, Seoul, Korea. JANGYS1212@yuhs.ac.ORCID https://orcid.org/0000-0002-2169-3112

Funding

Handok Kalos MedicalKorea Health Industry Development Institute HI16C0924Korea Health Industry Development Institute HI20C1566
6 · The paper itself

Abstract

BACKGROUND AND

objectivesDENEX™ 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.

methodsThis 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.

resultsNo 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.

conclusionRDN 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 registrationClinicalTrials.gov Identifier: NCT04248530.

Indexed as

Catheter ablationDenervationDrug resistanceHypertension

Identifiers

PMID33377328
PMCPMC7779817

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.