Evidence map›Paper›PMID 36254733›Full record

Trial reportHypertension (Dallas, Tex. : 1979)2022

Transurethral Renal Pelvic Denervation: A Feasibility Trial in Patients with Uncontrolled Hypertension.

Dagmara Hering, David Nikoleishvili, Avtandil Imedadze, Gvantsa Dughashvili, Zurab Klimiashvili, Eter Bekaia, Tamar Shengelia, Mamuka Kobalava, Otar Goguadze, Tamar Emukhvari and 3 more

Registry-linked trialOpen access · hybridAbstract readClinical Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Hypertension (Dallas, Tex. : 1979), 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05440513 (Trans Ureteral Sympathectomy of the Kidney Study Using the Verve Medical Phoenix ™ System), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
1.3field-weighted citation impact, top 18% 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.

NCT05440513 naunknown statusnot on this map

Trans Ureteral Sympathectomy of the Kidney Study Using the Verve Medical Phoenix ™ System

TypeinterventionalSponsorVerve Medical, IncRan2021 to 2022Enrolled20ConditionsHypertension, Uncontrolled HypertensionArmsRenal Pelvic Denervation (bilateral)
3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 8 citations in OpenAlex.

  1. Article
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

13 authors at 7 institutions in 5 countries.

Dagmara HeringCollege of Health Solutions, Arizona State University, Phoenix, AZ (D.H.).ORCID 0000-0003-4649-9524
David NikoleishviliDepartment of Hypertension and Diabetology, Medical University of Gdansk, Gdansk, Poland (D.H.).
Avtandil ImedadzePineo Medical Ecosystem, Tbilisi, Georgia (A.I., Z.K., T.S., O.G.).
Gvantsa DughashviliIsraeli-Georgian Medical Research Clinic Helsicore, Tbilisi, Georgia (D.N., G.D., E.B., M.K., T.E.).
Zurab KlimiashviliPineo Medical Ecosystem, Tbilisi, Georgia (A.I., Z.K., T.S., O.G.).ORCID 0000-0003-4047-4799
Eter BekaiaIsraeli-Georgian Medical Research Clinic Helsicore, Tbilisi, Georgia (D.N., G.D., E.B., M.K., T.E.).
Tamar ShengeliaPineo Medical Ecosystem, Tbilisi, Georgia (A.I., Z.K., T.S., O.G.).ORCID 0000-0002-6136-9309
Mamuka KobalavaIsraeli-Georgian Medical Research Clinic Helsicore, Tbilisi, Georgia (D.N., G.D., E.B., M.K., T.E.).ORCID 0000-0003-0528-4498
Otar GoguadzePineo Medical Ecosystem, Tbilisi, Georgia (A.I., Z.K., T.S., O.G.).
Tamar EmukhvariIsraeli-Georgian Medical Research Clinic Helsicore, Tbilisi, Georgia (D.N., G.D., E.B., M.K., T.E.).
Vitaly DrukerWest End Statistics, LLC (V.D.).ORCID 0000-0003-1778-9813
Jonathan Sackner-BernsteinExVivos, LLC, Pleasantville, NY (J.S.-B.).ORCID 0000-0003-0536-5132
Michael A WeberDivision of Cardiovascular Medicine, State University of New York, Downstate Medical School, Brooklyn, NY (M.A.W.).ORCID 0000-0002-8504-0831
David Tvildiani Medical University · GETbilisi State Medical University · GEArizona State University · USGdańsk Medical University · PLSt. Joseph's Hospital and Medical Center · USSUNY Downstate Health Sciences University · USWest End Hospital · GH

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundEndovascular renal denervation reduces blood pressure (BP). We explored an alternative approach to renal denervation using radiofrequency energy delivered across the renal pelvis utilizing the natural orifice of the urethra and the ureters.

methodsThis open-label, single-arm feasibility study enrolled patients with uncontrolled hypertension despite antihypertensive drug therapy. The primary effectiveness endpoint was the change in ambulatory daytime systolic BP (SBP) 2 months following renal pelvic denervation.

resultsThe 18 patients (mean age 56±12 years) enrolled were taking an average of 2.7 antihypertensive drugs daily. Renal pelvic denervation reduced mean daytime SBP by 19.4 mm Hg (95% CI, -24.9 to -14.0,

conclusionsBased on these initial findings, a well-powered, sham-controlled trial of renal pelvic denervation to more fully establish its safety and effectiveness is now justified in patients with uncontrolled hypertension despite drug therapy. REGISTRATION: URL: https://www. CLINICALTRIALS: gov; Unique identifier: NCT05440513.

Indexed as

HypertensionSympathectomyAdultAgedAntihypertensive AgentsBlood PressureBlood Pressure Monitoring, AmbulatoryDenervationFeasibility StudiesHumansKidneyKidney PelvisMiddle AgedRenal ArteryTreatment OutcomeAntihypertensive Agentsambulatory blood pressurekidney pelvisrenal denervationsham procedureuncontrolled hypertension

Identifiers

PMID36254733
PMCPMC9640249
OpenAlexW4306690302

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.