Evidence map›Paper›PMID 28864691›Full record

Trial reportBMJ open2017

Efficacy and safety of renal denervation for Chinese patients with resistant hypertension using a microirrigated catheter: study design and protocol for a prospective multicentre randomised controlled trial.

Zongjun Liu, Li Shen, Weijian Huang, Xianxian Zhao, Weiyi Fang, Changqian Wang, Zhaofang Yin, Jianan Wang, Guosheng Fu, Xuebo Liu and 5 more

Registry-linked trialOpen access · goldAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in BMJ open, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02900729 (A Prospective Multicenter Randomized Controlled Trial of Efficacy and Safety of Renal Denervation for Resistant Hypertension), which is not on this map. Cited by 3 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed, 1 pooled it
0.4field-weighted citation impact, top 34% of its field
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.

NCT02900729 phase3unknown statusnot on this map

A Prospective Multicenter Randomized Controlled Trial of Efficacy and Safety of Renal Denervation for Resistant Hypertension

TypeinterventionalSponsorShanghai WiseGain Medical Devices Co., Ltd.Ran2016 to 2018Enrolled254ConditionsHypertensionArmsRadiofrequency ablation catheter, Amlodipine, losartan potassium and hydrochlorothiazide
3 · Its place in the literature

Who cites it

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

  1. Renal denervation for resistant hypertension.The Cochrane database of systematic reviews · 2021
    Pooled it
  2. Review
  3. 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

15 authors at 12 institutions in 1 country.

Zongjun LiuDepartment of Cardiology, Putuo Hospital affiliated to Shanghai Traditional Chinese Medicine University, Shanghai, China.
Li ShenDepartment of Cardiology, Zhongshan Hospital affiliated to Fu Dan University, Shanghai, China.
Weijian HuangDepartment of Cardiology, The First Hospital affiliated to Wenzhou Medical College, Wenzhou, China.
Xianxian ZhaoDepartment of Cardiology, Changhai Hospital affiliated to Second Military Medical University, Shanghai, China.
Weiyi FangDepartment of Cardiology, Shanghai Chest Hospital affiliated to Shanghai Jiao Tong University, Shanghai, China.
Changqian WangDepartment of Cardiology, Shanghai Ninth People's Hospital affiliated to Shanghai Jiao Tong University, Shanghai, China.
Zhaofang YinDepartment of Cardiology, Shanghai Ninth People's Hospital affiliated to Shanghai Jiao Tong University, Shanghai, China.
Jianan WangDepartment of Cardiology, The Second Hospital affiliated to Zhejiang University, Hangzhou, China.
Guosheng FuDepartment of Cardiology, Sir Run Run Shaw Hospital affiliated to Zhejiang University, Hangzhou, China.
Xuebo LiuDepartment of Cardiology, Tongji Hospital affiliated to Tongji University, Shanghai, China.
Jianjun JiangDepartment of Cardiology, Taizhou Hospital, Taizhou, China.
Zhihui ZhangDepartment of Cardiology, The Third Xiangya Hospital of Central South University, China.
Jingbo LiDepartment of Cardiology, Shanghai Sixth People's Hospital affiliated to Shanghai Jiao Tong University, Shanghai, China.
Yingmin LuDepartment of Cardiology, Xinhua Hospital affiliated to Shanghai Jiao Tong University School of Medicine Chongming Branch, Shanghai, China.
Junbo GeDepartment of Cardiology, Zhongshan Hospital affiliated to Fu Dan University, Shanghai, China.
Shanghai Ninth People's Hospital · CNZhongshan Hospital · CNCentral South University · CNChanghai Hospital · CNFirst Affiliated Hospital of Wenzhou Medical University · CNSecond Affiliated Hospital of Zhejiang University · CNShanghai Chest Hospital · CNShanghai Jiao Tong University · CNSir Run Run Shaw Hospital · CNTongji University · CNWenzhou Medical University · CNXinHua Hospital · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionAvailable data show that approximately 8%-18% of patients with primary hypertension will develop resistant hypertension. In recent years, catheter-based renal denervation (RDN) has emerged as a potential treatment option for resistant hypertension. A number of observational studies and randomised controlled trials among non-Chinese patients have demonstrated its potential safety and efficacy. METHODS AND ANALYSIS: This is a multicentre, randomised, open-label, parallel-group, active controlled trial that will investigate the efficacy and safety of a 5F saline-irrigated radiofrequency ablation (RFA) used for RDN in the treatment of Chinese patients with resistant hypertension. A total of 254 patients who have failed pharmacological therapy will be enrolled. Eligible subjects will be randomised in a 1:1 ratio to undergo RDN using the RFA plus antihypertensive medication or to receive treatment with antihypertensive medication alone. The primary outcome measure is the change in 24 hours average ambulatory systolic blood pressure from baseline to 3 months, comparing the RDN-plus-medication group with the medication-alone group. Important secondary endpoints include the change in office blood pressure from baseline to 6 months after randomisation. Safety endpoints such as changes in renal function will also be evaluated. The full analysis set, according to the intent-to-treat principle, will be established as the primary analysis population. ETHICS AND DISSEMINATION: All participants will provide informed consent; the study protocol has been approved by the Independent Ethics Committee for each site. This study is designed to investigate the efficacy and safety of RDN using a 5F saline microirrigated RFA. Findings will be shared with participating hospitals, policymakers and the academic community to promote the clinical management of resistant hypertension in China.

trial registrationClinicalTrials.gov ID: NCT02900729; pre-results.

Indexed as

Blood PressureKidneyAdolescentAdultAgedAsian PeopleCatheter AblationDenervationEssential HypertensionFemaleHumansHypertensionMaleMiddle AgedProspective StudiesRenal Arteryambulatory blood pressureChinese patientsradiofrequency ablationrenal denervationresistant hypertension

Identifiers

PMID28864691
PMCPMC5588951
OpenAlexW2750801972

What OpenQuestion holds

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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.