Evidence map›Paper›PMID 39215531›Full record

Trial reportEuropean heart journal2024

In-hospital initiation of angiotensin receptor-neprilysin inhibition in acute heart failure: the PREMIER trial.

Atsushi Tanaka, Keisuke Kida, Yuya Matsue, Takumi Imai, Satoru Suwa, Isao Taguchi, Itaru Hisauchi, Hiroki Teragawa, Yoshiyuki Yazaki, Masao Moroi and 20 more

Registry-linked trialAbstract readMulticenter StudyRandomized Controlled TrialPragmatic Clinical Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in European heart journal, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05164653 (An Investigator-initiated, Multicenter, Prospective, Randomized, Open-label, Blinded-endpoint Study to Assess the Effect of In-hospital Initiation of Sacubitril Valsartan on the NT-proBNP Concentrations in Patients Admitted Due to Acute Exacerbation of Heart Failure), which is not on this map. Cited by 8 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing 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.

NCT05164653 phase4active not recruitingnot on this map

An Investigator-initiated, Multicenter, Prospective, Randomized, Open-label, Blinded-endpoint Study to Assess the Effect of In-hospital Initiation of Sacubitril Valsartan on the NT-proBNP Concentrations in Patients Admitted Due to Acute Exacerbation of Heart Failure (PREMIER)

TypeinterventionalSponsorSaga UniversityRan2021 to 2025Enrolled400ConditionsHeart FailureArmsSacubitril Valsartan Sodium Hydrate, Standard treatment
3 · Its place in the literature

Who cites it

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

  1. Pooled it
  2. Trial
  3. Update on clinical heart failure trials.Clinical research in cardiology : official journal of the German Cardiac Society · 2026
    Review
  4. Article
  5. Different aspects of pharmacological heart failure treatment.European heart journal. Cardiovascular pharmacotherapy · 2025
    Article
  6. Review
  7. Article
  8. 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

30 authors.

Atsushi TanakaDepartment of Cardiovascular Medicine, Saga University, 5-1-1 Nabeshima, Saga 849-8501, Japan.ORCID 0000-0003-3352-7661
Keisuke KidaDepartment of Pharmacology, St. Marianna University School of Medicine, Kawasaki, Japan.
Yuya MatsueDepartment of Cardiovascular Biology and Medicine, Juntendo University Graduate School of Medicine, Tokyo, Japan.
Takumi ImaiClinical Research Division, Organization for Clinical Medicine Promotion, Tokyo, Japan.
Satoru SuwaDepartment of Cardiology, Juntendo University Shizuoka Hospital, Shizuoka, Japan.
Isao TaguchiDepartment of Cardiology, Dokkyo Medical University Saitama Medical Center, Koshigaya, Japan.
Itaru HisauchiDepartment of Cardiology, Dokkyo Medical University Saitama Medical Center, Koshigaya, Japan.
Hiroki TeragawaDepartment of Cardiovascular Medicine, JR Hiroshima Hospital, Hiroshima, Japan.ORCID 0000-0002-0183-2541
Yoshiyuki YazakiDivision of Cardiovascular Medicine, Toho University Ohashi Medical Center, Tokyo, Japan.
Masao MoroiDivision of Cardiovascular Medicine, Toho University Ohashi Medical Center, Tokyo, Japan.
Koichi OhashiDepartment of Cardiology, Tokyo Metropolitan Bokutoh Hospital, Tokyo, Japan.
Daisuke NagatomoDivision of Cardiology, Cardiovascular and Aortic Center, Saiseikai Fukuoka General Hospital, Fukuoka, Japan.
Toru KubotaDivision of Cardiology, Cardiovascular and Aortic Center, Saiseikai Fukuoka General Hospital, Fukuoka, Japan.
Takeshi IjichiDepartment of Cardiology, Tokai University, Isehara, Japan.
Yuji IkariDepartment of Cardiology, Tokai University, Isehara, Japan.
Keisuke YonezuDepartment of Cardiology and Clinical Examination, Faculty of Medicine, Oita University, Yufu, Japan.
Naohiko TakahashiDepartment of Cardiology and Clinical Examination, Faculty of Medicine, Oita University, Yufu, Japan.ORCID 0000-0001-9037-0010
Shigeru ToyodaDepartment of Cardiovascular Medicine, Dokkyo Medical University, Mibu, Japan.
Tsutomu ToshidaDivision of Cardiology, Department of Internal Medicine, Showa University Fujigaoka Hospital, Yokohama, Japan.
Hiroshi SuzukiDivision of Cardiology, Department of Internal Medicine, Showa University Fujigaoka Hospital, Yokohama, Japan.
Tohru MinaminoDepartment of Cardiovascular Biology and Medicine, Juntendo University Graduate School of Medicine, Tokyo, Japan.
Kazutaka NogiDepartment of Cardiovascular Medicine, Nara Medical University, Kashihara, Japan.
Kazuki ShiinaDepartment of Cardiology, Tokyo Medical University, Tokyo, Japan.
Yu HoriuchiDivision of Cardiology, Mitsui Memorial Hospital, Tokyo, Japan.
Kengo TanabeDivision of Cardiology, Mitsui Memorial Hospital, Tokyo, Japan.
Daisuke HachinoheDepartment of Cardiology, Sapporo Heart Center, Sapporo Cardio Vascular Clinic, Sapporo, Japan.
Shunsuke KiuchiDepartment of Cardiovascular Medicine, Toho University Faculty of Medicine, Tokyo, Japan.
Kenya KusunoseDepartment of Cardiovascular Medicine, Nephrology, and Neurology, Graduate School of Medicine, University of the Ryukyus, Okinawa, Japan.ORCID 0000-0002-4909-754X
Michio ShimabukuroDepartment of Diabetes, Endocrinology, and Metabolism, Fukushima Medical University School of Medicine, Fukushima, Japan.ORCID 0000-0001-7835-7665
Koichi NodeDepartment of Cardiovascular Medicine, Saga University, 5-1-1 Nabeshima, Saga 849-8501, Japan.ORCID 0000-0002-2534-0939

Funding

Novartis K.K.
6 · The paper itself

Abstract

BACKGROUND AND

aimsThe efficacy and safety of early sacubitril/valsartan (Sac/Val) initiation after acute heart failure (AHF) has not been demonstrated outside North America. The present study aimed to evaluate the effect of in-hospital Sac/Val therapy initiation after an AHF episode on N-terminal pro-B-type natriuretic peptide (NT-proBNP) level in Japanese patients.

methodsThis was an investigator-initiated, multicentre, prospective, randomized, open-label, blinded-endpoint pragmatic trial. After haemodynamic stabilization within 7 days after hospitalization, eligible inpatients were allocated to switch from angiotensin-converting enzyme inhibitor or angiotensin receptor blocker to Sac/Val (Sac/Val group) or to continue angiotensin-converting enzyme inhibitor or angiotensin receptor blocker (control group). The primary efficacy endpoint was the 8-week proportional change in geometric means of NT-proBNP levels.

resultsA total of 400 patients were equally randomized, and 376 (median age 75 years, 31.9% women, de novo heart failure rate 55.6%, and median left ventricular ejection fraction 37%) were analysed. The per cent changes in NT-proBNP level geometric means at Weeks 4/8 were -35%/-45% (Sac/Val group) and -18%/-32% (control group), and their group ratio (Sac/Val vs. control) was 0.80 (95% confidence interval 0.68-0.94; P = .008) at Week 4 and 0.81 (95% confidence interval 0.68-0.95; P = .012) at Week 8, respectively. In the pre-specified subgroup analyses, the effects of Sac/Val were confined to patients with a left ventricular ejection fraction < 40% and were more evident in those in sinus rhythm and taking mineralocorticoid receptor antagonists. No adverse safety signal was evident.

conclusionsIn-hospital Sac/Val therapy initiation in addition to contemporary recommended therapy triggered a greater NT-proBNP level reduction in Japanese patients hospitalized for AHF. These findings may expand the evidence on Sac/Val therapy in this clinical situation outside North America. CLINICAL

trial registrationClinicalTrial.gov (NCT05164653) and Japan Registry of Clinical Trials (jRCTs021210046).

Indexed as

AminobutyratesAngiotensin Receptor AntagonistsBiphenyl CompoundsDrug CombinationsHeart FailureNatriuretic Peptide, BrainNeprilysinPeptide FragmentsTetrazolesValsartanAcute DiseaseAgedAged, 80 and overAngiotensin-Converting Enzyme InhibitorsFemaleHospitalizationAminobutyratesAngiotensin-Converting Enzyme InhibitorsAngiotensin Receptor AntagonistsBiphenyl CompoundsDrug CombinationsNatriuretic Peptide, BrainNeprilysinPeptide Fragmentspro-brain natriuretic peptide (1-76)sacubitril and valsartan sodium hydrate drug combinationTetrazolesValsartanAcute heart failureN-terminal pro-B-type natriuretic peptideSacubitril/valsartan

Identifiers

PMID39215531
PMCPMC11544311

What Socratic holds

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LicenceCC BY
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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 Socratic graph.