Evidence map›Paper›PMID 32977831›Full record

Trial reportCardiovascular diabetology2020

Effects of empagliflozin versus placebo on cardiac sympathetic activity in acute myocardial infarction patients with type 2 diabetes mellitus: the EMBODY trial.

Wataru Shimizu, Yoshiaki Kubota, Yu Hoshika, Kosuke Mozawa, Shuhei Tara, Yukichi Tokita, Kenji Yodogawa, Yu-Ki Iwasaki, Takeshi Yamamoto, Hitoshi Takano and 10 more

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

Trial report in Cardiovascular diabetology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06313008 (A Clinical Study Comparing Effects of Empagliflozin Versus Vildagliptin on Inflammatory Biomarkers, and Atrial Function in Coronary Artery Disease Patients With Type 2 Diabetes), which is not on this map. Cited by 124 papers, 23 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
124citing papers in PubMed, 23 pooled it
17.3field-weighted citation impact, top 1% 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.

NCT06313008 nacompletedstarted 2023, after this paper: background citation

A Clinical Study Comparing Effects of Empagliflozin Versus Vildagliptin on Inflammatory Biomarkers, and Atrial Function in Coronary Artery Disease Patients With Type 2 Diabetes: EMBA-VILDA-Response Trial.

Ran2023Enrolled120Registered outcomes6Posted comparisons0ConditionsCoronary Artery Disease, Type 2 DiabetesArmsempagliflozin 10 mg, Vildagliptin 50 mg
PMID 27210264PMID 28403850PMID 27701934other papers from this trial
Open the trial in the graph
3 · Its place in the literature

Who cites it

124 citing papers in PubMed, 23 syntheses or guidelines pooled it, 226 citations in OpenAlex.

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64 more citing papers are in PubMed but not listed here.

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

20 authors at 4 institutions in 1 country.

Wataru ShimizuDepartment of Cardiovascular Medicine, Nippon Medical School, 1-1-5, Sendagi, Bunkyo-ku, Tokyo, 113-0022, Japan. wshimizu@nms.ac.jp.ORCID 0000-0001-9941-8973
Yoshiaki KubotaDepartment of Cardiovascular Medicine, Nippon Medical School, 1-1-5, Sendagi, Bunkyo-ku, Tokyo, 113-0022, Japan.
Yu HoshikaDepartment of Cardiovascular Medicine, Nippon Medical School, 1-1-5, Sendagi, Bunkyo-ku, Tokyo, 113-0022, Japan.
Kosuke MozawaDepartment of Cardiovascular Medicine, Nippon Medical School, 1-1-5, Sendagi, Bunkyo-ku, Tokyo, 113-0022, Japan.
Shuhei TaraDepartment of Cardiovascular Medicine, Nippon Medical School, 1-1-5, Sendagi, Bunkyo-ku, Tokyo, 113-0022, Japan.
Yukichi TokitaDepartment of Cardiovascular Medicine, Nippon Medical School, 1-1-5, Sendagi, Bunkyo-ku, Tokyo, 113-0022, Japan.
Kenji YodogawaDepartment of Cardiovascular Medicine, Nippon Medical School, 1-1-5, Sendagi, Bunkyo-ku, Tokyo, 113-0022, Japan.
Yu-Ki IwasakiDepartment of Cardiovascular Medicine, Nippon Medical School, 1-1-5, Sendagi, Bunkyo-ku, Tokyo, 113-0022, Japan.
Takeshi YamamotoDepartment of Cardiovascular Medicine, Nippon Medical School, 1-1-5, Sendagi, Bunkyo-ku, Tokyo, 113-0022, Japan.
Hitoshi TakanoDepartment of Cardiovascular Medicine, Nippon Medical School, 1-1-5, Sendagi, Bunkyo-ku, Tokyo, 113-0022, Japan.
Yayoi TsukadaDepartment of Cardiovascular Medicine, Nippon Medical School, 1-1-5, Sendagi, Bunkyo-ku, Tokyo, 113-0022, Japan.
Kuniya AsaiDepartment of Cardiovascular Medicine, Nippon Medical School, 1-1-5, Sendagi, Bunkyo-ku, Tokyo, 113-0022, Japan.
Masaaki MiyamotoDepartment of Cardiovascular Medicine, Nippon Medical School, 1-1-5, Sendagi, Bunkyo-ku, Tokyo, 113-0022, Japan.
Yasushi MiyauchiDepartment of Cardiovascular Medicine, Nippon Medical School Chiba Hokuso Hospital, Chiba, Japan.
Eitaro KodaniDepartment of Cardiovascular Medicine, Nippon Medical School Tama Nagayama Hospital, Tokyo, Japan.
Masahiro IshikawaDepartment of Cardiovascular Medicine, Nippon MEDICAL School Musashi Kosugi Hospital, Tokyo, Japan.
Mitsunori MaruyamaDepartment of Cardiovascular Medicine, Nippon MEDICAL School Musashi Kosugi Hospital, Tokyo, Japan.
Michio OganoDepartment of Cardiovascular Medicine, Shizuoka Medical Center, Shizuoka, Japan.
Jun TanabeDepartment of Cardiovascular Medicine, Shizuoka Medical Center, Shizuoka, Japan.
EMBODY trial investigators
Nippon Medical School · JPChiba Hokusou Hospital · JPNippon Medical School Musashi Kosugi Hospital · JPShizuoka Medical Center · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundProtection from lethal ventricular arrhythmias leading to sudden cardiac death (SCD) is a crucial challenge after acute myocardial infarction (AMI). Cardiac sympathetic and parasympathetic activity can be noninvasively assessed using heart rate variability (HRV) and heart rate turbulence (HRT). The EMBODY trial was designed to determine whether the Sodium-glucose cotransporter 2 (SGLT2) inhibitor improves cardiac nerve activity.

methodsThis prospective, multicenter, randomized, double-blind, placebo-controlled trial included patients with AMI and type 2 diabetes mellitus (T2DM) in Japan; 105 patients were randomized (1:1) to receive once-daily 10-mg empagliflozin or placebo. The primary endpoints were changes in HRV, e.g., the standard deviation of all 5-min mean normal RR intervals (SDANN) and the low-frequency-to-high-frequency (LF/HF) ratio from baseline to 24 weeks. Secondary endpoints were changes in other sudden cardiac death (SCD) surrogate markers such as HRT.

resultsOverall, 96 patients were included (46, empagliflozin group; 50, placebo group). The changes in SDANN were + 11.6 and + 9.1 ms in the empagliflozin (P = 0.02) and placebo groups (P = 0.06), respectively. Change in LF/HF ratio was - 0.57 and - 0.17 in the empagliflozin (P = 0.01) and placebo groups (P = 0.43), respectively. Significant improvement was noted in HRT only in the empagliflozin group (P = 0.01). Whereas intergroup comparison on HRV and HRT showed no significant difference between the empagliflozin and placebo groups. Compared with the placebo group, the empagliflozin group showed significant decreases in body weight, systolic blood pressure, and uric acid. In the empagliflozin group, no adverse events were observed.

conclusionsThis is the first randomized clinical data to evaluate the effect of empagliflozin on cardiac sympathetic and parasympathetic activity in patients with T2DM and AMI. Early SGLT2 inhibitor administration in AMI patients with T2DM might be effective in improving cardiac nerve activity without any adverse events.

trial registrationThe EMBODY trial was registered by the UMIN in November 2017 (ID: 000030158). UMIN000030158; https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034442 .

Indexed as

Heart Rate3-IodobenzylguanidineAgedBenzhydryl CompoundsBlood PressureBody WeightDeath, Sudden, CardiacDiabetes Mellitus, Type 2Double-Blind MethodElectrocardiography, AmbulatoryFemaleGlucosidesHumansMaleMiddle AgedMyocardial Infarction3-IodobenzylguanidineBenzhydryl CompoundsempagliflozinGlucosidesRadiopharmaceuticalsSodium-Glucose Transporter 2 InhibitorsUric AcidAcute Myocardial InfarctionHeart rate turbulenceHeart rate variabilityRandomized Controlled TrialSodium–glucose cotransporter 2 inhibitorSudden cardiac death

Identifiers

PMID32977831
PMCPMC7519555
OpenAlexW3088460171

What OpenQuestion holds

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LicenceCC BY
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.