Evidence map›Paper›PMID 40295134›Full record

ArticleBMJ open2025

Evaluation of the efficacy of angiotensin receptor-neprilysin inhibitor in patients with aortic stenosis undergoing transcatheter aortic valve implantation: protocol for a randomised, open-label, controlled study.

Hideki Kitahara, Shogo Okita, Takeshi Sugawara, Hiroaki Yaginuma, Hiroki Goto, Hiroaki Yamamoto, Tomoyoshi Kanda, Kaoru Matsuura, Yosuke Inaba, Hideki Hanaoka and 2 more

Abstract readClinical Trial Protocol
In one paragraph

Article in BMJ open, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Review
  2. 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

12 authors.

Hideki KitaharaDepartment of Cardiovascular Medicine, Chiba University Graduate School of Medicine, Chiba, Japan hidekitahara0306@gmail.com.ORCID http://orcid.org/0000-0002-2888-6160
Shogo OkitaDepartment of Cardiovascular Medicine, Chiba University Graduate School of Medicine, Chiba, Japan.
Takeshi SugawaraOphthalmology, Chiba University Hospital, Chiba, Japan.ORCID http://orcid.org/0009-0000-3664-1158
Hiroaki YaginumaDepartment of Cardiovascular Medicine, Chiba University Graduate School of Medicine, Chiba, Japan.
Hiroki GotoDepartment of Cardiovascular Medicine, Chiba University Graduate School of Medicine, Chiba, Japan.
Hiroaki YamamotoDepartment of Cardiovascular Surgery, Chiba University Graduate School of Medicine, Chiba, Japan.
Tomoyoshi KandaDepartment of Cardiovascular Surgery, Chiba University Graduate School of Medicine, Chiba, Japan.
Kaoru MatsuuraDepartment of Cardiovascular Surgery, Chiba University Graduate School of Medicine, Chiba, Japan.
Yosuke InabaClinical Research Center, Chiba University Hospital, Chiba, Japan.
Hideki HanaokaClinical Research Center, Chiba University Hospital, Chiba, Japan.
Goro MatsumiyaDepartment of Cardiovascular Surgery, Chiba University Graduate School of Medicine, Chiba, Japan.
Yoshio KobayashiDepartment of Cardiovascular Medicine, Chiba University Graduate School of Medicine, Chiba, Japan.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionThere are a substantial number of patients developing heart failure after transcatheter aortic valve implantation (TAVI) for severe aortic stenosis (AS), even though AS has been successfully treated. The purpose of this randomised controlled trial was to determine whether the addition of an angiotensin receptor-neprilysin inhibitor (ARNI), sacubitril/valsartan, is superior to conventional medications in lowering N-terminal pro-B-type natriuretic peptide (NT-proBNP) levels in patients undergoing TAVI for AS. METHODS AND ANALYSIS: The study design is a prospective, single-centre, open-label, randomised, parallel-group, two-arm study, in which participants will be randomised in a 1:1 ratio to receive either conventional medications plus ARNI or conventional medications only. In the ARNI group, if a patient was on an ACE inhibitor or angiotensin II receptor blocker before TAVI, it will be switched to ARNI 100 mg/day (50 mg two times per day) on the first postoperative day. If not, candesartan 4 mg/day will be started 1-2 days before TAVI, and switched to ARNI 100 mg/day on the first postoperative day. As the patient has tolerability to ARNI, dosage will be increased stepwise to 400 mg/day 2-4 weeks apart. ARNI will be continued until at least 6-month follow-up. In the control group, the patient will receive conventional medications. The primary endpoint is the serum NT-proBNP value at 6-month follow-up after TAVI. Each group includes 42 patients (84 total patients). ETHICS AND DISSEMINATION: Ethical approval for this study has been obtained from the Chiba University Hospital Certified Clinical Research Review Board (CRB3180015). The study is ongoing. Findings from this study will be disseminated through peer-reviewed publications and conference presentations. TRIAL REGISTRATION NUMBER: This trial has been registered on the Japan Registry of Clinical Trials: jRCT1031220344.

Indexed as

AminobutyratesAngiotensin Receptor AntagonistsAortic Valve StenosisNeprilysinTetrazolesTranscatheter Aortic Valve ReplacementAngiotensin-Converting Enzyme InhibitorsBiphenyl CompoundsDrug CombinationsFemaleHeart FailureHumansMaleNatriuretic Peptide, BrainPeptide FragmentsProspective StudiesAminobutyratesAngiotensin-Converting Enzyme InhibitorsAngiotensin Receptor AntagonistsBiphenyl CompoundsDrug CombinationsNatriuretic Peptide, BrainNeprilysinPeptide Fragmentspro-brain natriuretic peptide (1-76)sacubitril and valsartan sodium hydrate drug combinationTetrazolesValsartanAdult cardiologyHeart failureValvular heart disease

Identifiers

PMID40295134
PMCPMC12039011

What OpenQuestion holds

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Registered trials

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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.