Evidence map›Paper›PMID 32578353›Full record

ArticleESC heart failure2020

Rationale and design of the EMPYREAN study.

Hirohiko Motoki, Izuru Masuda, Shinji Yasuno, Koji Oba, Wataru Shoin, Satoru Usami, Yoshihiko Saito, Masako Waki, Mitsuhisa Komatsu, Kenji Ueshima and 7 more

Open access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in ESC heart failure, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
0.9field-weighted citation impact, top 23% 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.

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

3 citing papers in PubMed, 7 citations in OpenAlex.

  1. Trial
  2. Design, Spectral Insights, and Enhanced Antioxidant Potential of Novel Phenothiazine DerivativesAnti-inflammatory & anti-allergy agents in medicinal chemistry · 2026
    Article
  3. 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

17 authors at 13 institutions in 2 countries.

Hirohiko MotokiDepartment of Cardiovascular Medicine, Shinshu University School of Medicine, 3-1-1 Asahi, Matsumoto, Nagano, 390-8621, Japan.
Izuru MasudaMedical Examination Center, Takeda Hospital, Kyoto, Japan.
Shinji YasunoClinical Research Support Center, The Jikei University School of Medicine, Tokyo, Japan.
Koji ObaDepartment of Biostatistics, School of Public Health, The University of Tokyo, Tokyo, Japan.
Wataru ShoinDepartment of Cardiovascular Medicine, Shinshu University School of Medicine, 3-1-1 Asahi, Matsumoto, Nagano, 390-8621, Japan.
Satoru UsamiDepartment of Internal Medicine, Taigenkai Hospital, Ichinomiya, Japan.
Yoshihiko SaitoDepartment of Cardiovascular Medicine, Nara Medical University, Kashihara, Japan.
Masako WakiShizuoka City Shizuoka Hospital, Shizuoka, Japan.
Mitsuhisa KomatsuDivision of Diabetes, Endocrinology and Metabolism, Department of Internal Medicine, Shinshu University School of Medicine, Matsumoto, Japan.
Kenji UeshimaDepartment of EBM Research, Institute for Advancement of Clinical and Translational Science, Kyoto University Hospital, Kyoto, Japan.
Yasuaki NakagawaDepartment of Cardiovascular Medicine, Kyoto University Graduate School of Medicine, Kyoto, Japan.
Cheol SonDivision of Endocrinology and Metabolism, National Cerebral and Cardiovascular Center, Suita, Japan.
Shin YonemitsuDepartment of Diabetes and Endocrinology, Osaka Red Cross Hospital, Osaka, Japan.
Shinya HiramitsuHiramitsu Heart Clinic, Nagoya, Japan.
Manako KondaDepartment of Preventive Services, Kyoto University School of Public Health, Kyoto, Japan.
Katsuya OnishiOnishi Heart Clinic, Tsu, Japan.
Koichiro KuwaharaDepartment of Cardiovascular Medicine, Shinshu University School of Medicine, 3-1-1 Asahi, Matsumoto, Nagano, 390-8621, Japan.
Shinshu University · JPKyoto University · JPIchinomiya Kenshin College · JPJikei University School of Medicine · JPKyoto University Hospital · JPNagoya Heart Center · JPNara Medical University · JPNational Cerebral and Cardiovascular Center · JPOsaka Red Cross Hospital · JPShizuoka City Hospital · JPTakeda (Japan) · JPThe University of Tokyo · JPUnited Heart and Vascular Clinic · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimsA sodium glucose cotransporter 2 (SGLT2) inhibitor was recently found to reduce heart failure hospitalization in the EMPA-REG OUTCOME trial. We have hypothesized that autonomic nerve activity may be modulated by SGLT2 inhibition. The current study aims to investigate the impact of empagliflozin on sympathetic and parasympathetic nerve activity in patients with type 2 diabetes mellitus. METHODS AND

resultsThis ongoing study is a prospective, randomized, open-label, multicentre investigation of 134 patients with type 2 diabetes mellitus. The patients are randomly allocated to receive either empagliflozin or sitagliptin with the treatment goal of the Japan Diabetes Society guidelines. Ambulatory electrocardiographic monitoring is performed at the baseline and at 12 and 24 weeks of treatment. Analyses of heart rate variability are conducted using the MemCalc method, which is a combination of the maximum entropy method for spectral analysis and the non-linear least squares method for square analysis. The primary endpoint is the change in the low-frequency (0.04-0.15 Hz)/high-frequency (0.15-0.4 Hz) ratio from baseline to 24 weeks.

conclusionsThis investigation on the effect of EMPagliflozin on cardiac sYmpathetic and parasympathetic neRve activity in JapanEse pAtieNts with type 2 diabetes (EMPYREAN study) offers an important opportunity to understand the impact of SGLT2 inhibition on autonomic nerve activity in patients with type 2 diabetes.

Indexed as

Diabetes Mellitus, Type 2Sodium-Glucose Transporter 2 InhibitorsHumansJapanMulticenter Studies as TopicProspective StudiesRandomized Controlled Trials as TopicSodium-Glucose Transporter 2 InhibitorsDiabetes mellitusHeart rate variabilitySGLT2 inhibitors

Identifiers

PMID32578353
PMCPMC7524086
OpenAlexW3038093414

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

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.