Evidence mapPaperPMID 36289063Full record

Trial reportClinical research in cardiology : official journal of the German Cardiac Society2023

The SGLT2 inhibitor empagliflozin reduces tissue sodium content in patients with chronic heart failure: results from a placebo-controlled randomised trial.

Julie Kolwelter, Dennis Kannenkeril, Peter Linz, Susanne Jung, Armin M Nagel, Agnes Bosch, Christian Ott, Peter Bramlage, Lisa Nöh, Mario Schiffer and 3 more

Registry-linked trialOpen access · hybridAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Clinical research in cardiology : official journal of the German Cardiac Society, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It reports registered trial NCT03128528. Cited by 20 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
20citing papers in PubMed, 2 pooled it
7.7field-weighted citation impact, top 2% 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.

NCT03128528 phase2completed

Randomized, Double-blind, Placebo Controlled, Parallel-group, Prospective Clinical Study to Analyse the Effect of Empagliflozin on Reduction of Tissue Sodium Content in Patients With Chronic Heart Failure

Ran2017Enrolled84Registered outcomes14Posted comparisons0ConditionsChronic Heart FailureArmsempagliflozin 10mg, Placebo Oral Tablet
PMID 28923906other papers from this trial
Open the trial in the graph
3 · Its place in the literature

Who cites it

20 citing papers in PubMed, 2 syntheses or guidelines pooled it, 57 citations in OpenAlex.

  1. Pooled it
  2. Role of dietary sodium restriction in chronic heart failure: systematic review and meta-analysis.Clinical research in cardiology : official journal of the German Cardiac Society · 2024
    Pooled it
  3. Trial
  4. Trial
  5. Article
  6. Salt and chronic kidney disease.Nature reviews. Nephrology · 2026
    Review
  7. Article
  8. Review
  9. Review
  10. Article
  11. Article
  12. Targeting Sodium in Heart Failure.Journal of personalized medicine · 2024
    Review
  13. Proximal versus distal diuretics in congestive heart failure.Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association · 2024
    Review
  14. Article
  15. Review
  16. Skin sodium content as a predictor of blood pressure response to renal denervation.Hypertension research : official journal of the Japanese Society of Hypertension · 2024
    Article
  17. Review
  18. Review
  19. Article
  20. 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

13 authors at 4 institutions in 1 country.

Julie KolwelterDepartment of Nephrology and Hypertension, University Hospital Erlangen, Friedrich-Alexander University Erlangen-Nuremberg (FAU), Ulmenweg 18, 91054, Erlangen, Germany.
Dennis KannenkerilDepartment of Nephrology and Hypertension, University Hospital Erlangen, Friedrich-Alexander University Erlangen-Nuremberg (FAU), Ulmenweg 18, 91054, Erlangen, Germany.
Peter LinzDepartment of Nephrology and Hypertension, University Hospital Erlangen, Friedrich-Alexander University Erlangen-Nuremberg (FAU), Ulmenweg 18, 91054, Erlangen, Germany.
Susanne JungDepartment of Cardiology, University Hospital Erlangen, Friedrich-Alexander University Erlangen-Nuremberg (FAU), Erlangen, Germany.
Armin M NagelInstitute of Radiology, University Hospital Erlangen, Friedrich-Alexander University Erlangen-Nuremberg (FAU), Erlangen, Germany.
Agnes BoschDepartment of Nephrology and Hypertension, University Hospital Erlangen, Friedrich-Alexander University Erlangen-Nuremberg (FAU), Ulmenweg 18, 91054, Erlangen, Germany.
Christian OttDepartment of Nephrology and Hypertension, University Hospital Erlangen, Friedrich-Alexander University Erlangen-Nuremberg (FAU), Ulmenweg 18, 91054, Erlangen, Germany.
Peter BramlageInstitute for Pharmacology and Preventive Medicine, Cloppenburg, Germany.
Lisa NöhDepartment of Nephrology and Hypertension, University Hospital Erlangen, Friedrich-Alexander University Erlangen-Nuremberg (FAU), Ulmenweg 18, 91054, Erlangen, Germany.
Mario SchifferDepartment of Nephrology and Hypertension, University Hospital Erlangen, Friedrich-Alexander University Erlangen-Nuremberg (FAU), Ulmenweg 18, 91054, Erlangen, Germany.
Michael UderInstitute of Radiology, University Hospital Erlangen, Friedrich-Alexander University Erlangen-Nuremberg (FAU), Erlangen, Germany.
Stephan AchenbachDepartment of Cardiology, University Hospital Erlangen, Friedrich-Alexander University Erlangen-Nuremberg (FAU), Erlangen, Germany.
Roland E SchmiederDepartment of Nephrology and Hypertension, University Hospital Erlangen, Friedrich-Alexander University Erlangen-Nuremberg (FAU), Ulmenweg 18, 91054, Erlangen, Germany. Roland.Schmieder@uk-erlangen.de.
Universitätsklinikum Erlangen · DEFriedrich-Alexander-Universität Erlangen-Nürnberg · DEGerman Cancer Research Center · DEIPPMed (Germany) · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionSodium-glucose co-transporter 2 (SGLT2) inhibitors have cardiovascular protective properties in addition to the metabolic effects and represent a cornerstone of treating patients with chronic heart failure (CHF). We hypothesised that empagliflozin reduces tissue sodium content in patients with CHF.

methodsIn a double-blind, randomised (2:1), placebo-controlled, parallel-group, clinical trial, 74 patients with NYHA class II-III CHF and an ejection fraction of 49% or less received empagliflozin 10 mg once daily or placebo for 3 months. In each patient, tissue sodium content of the lower leg was assessed non-invasively by sodium-MRI (

resultsAfter 1 and 3 months treatment with empagliflozin (n = 48), a significant decrease in skin sodium content was observed (1 month: 22.8 ± 6.1 vs. 21.6 ± 6.0 AU, p = 0.039; 3 months: 22.9 ± 6.1 vs. 21.6 ± 6.1 AU, p = 0.013), while there was no change in muscle sodium and muscle water content. In direct comparison, the change in skin sodium content between baseline and 3 months was - 1.3 ± 3.5 AU in the empagliflozin group versus 0.6 ± 3.5 AU in the placebo group (p for between-group difference = 0.022). No significant difference regarding change in muscle sodium and in muscle water content was observed after 3 months treatment between the two groups.

conclusionThis trial showed a significant decrease in skin sodium content after 1 and 3 months of treatment with empagliflozin. The decrease in skin sodium content may reflect a decrease in subclinical micro-oedema or/and in non-osmotic bound tissue sodium, both reported to impair left ventricular function. TRIAL REGISTRATION NUMBER: NCT03128528 ( http://www. CLINICALTRIALS: gov ). TRIAL REGISTRATION DATE: 25th April 2017.

Indexed as

Diabetes Mellitus, Type 2Heart FailureSodium-Glucose Transporter 2 InhibitorsBenzhydryl CompoundsChronic DiseaseDouble-Blind MethodGlucosidesHumansSodiumSodium-Glucose Transporter 2Benzhydryl CompoundsempagliflozinGlucosidesSLC5A2 protein, humanSodiumSodium-Glucose Transporter 2Sodium-Glucose Transporter 2 InhibitorsChronic heart failureEmpagliflozinMagnetic resonance imagingSGLT2 inhibitorSodiumTissue sodium content

Identifiers

PMID36289063
PMCPMC9849317
OpenAlexW4307306654

What Socratic 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 Socratic graph.