Ertugliflozin to reduce arrhythmic burden in ICD/CRT patients (ERASe-trial) – A phase III study

Sodium glucose cotransporter 2 (SGLT2) have proven profound positive effects in heart failure with reduced ejection fraction (HFrEF). These effects are independent from the presence of diabetes. Metabolic effects, antiinflammatory, and antifibrotic properties are discussed as underlying mechanisms....

Full description

Saved in:
Bibliographic Details
Published in:The American heart journal 2022-04, Vol.246, p.152-160
Main Authors: von Lewinski, Dirk, Tripolt, Norbert J, Sourij, Harald, Pferschy, Peter N, Oulhaj, Abderrahim, Alber, Hannes, Gwechenberger, Marianne, Martinek, Martin, Seidl, Sebastian, Moertl, Deddo, Nürnberg, Michael, Roithinger, Franz Xaver, Steinwender, Clemens, Stühlinger, Markus, Zirlik, Andreas, Benedikt, Martin, Kolesnik, Ewald, Wallner, Markus, Rohrer, Ursula, Manninger, Martin, Scherr, Daniel
Format: Article
Language:English
Subjects:
Biomarkers
Blood pressure
Body mass index
Bridged Bicyclo Compounds, Heterocyclic - therapeutic use
Cardiac arrhythmia
Congestive heart failure
Defibrillators, Implantable
Diabetes
Diabetes mellitus
Documentation
Double-Blind Method
Drug dosages
Ejection fraction
Ethics
Fibrillation
Glucose
Health informatics
Heart failure
Heart Failure - drug therapy
Heart Failure - therapy
Humans
Hypotheses
Na+/glucose cotransporter
Oral administration
Patients
Placebos
Stroke Volume - physiology
Tachycardia
Telemedicine
Therapeutic applications
Treatment Outcome
Ventricle
Ventricular Function, Left - physiology
Citations: Items that this one cites
Items that cite this one
Online Access:Get full text
Tags: Add Tag
No Tags, Be the first to tag this record!
Description
Summary:Sodium glucose cotransporter 2 (SGLT2) have proven profound positive effects in heart failure with reduced ejection fraction (HFrEF). These effects are independent from the presence of diabetes. Metabolic effects, antiinflammatory, and antifibrotic properties are discussed as underlying mechanisms. Despite a strong correlation of ventricular arrhythmias with HFrEF, the impact of ertugliflozin on the ventricular arrhythmic burden has not been investigated, yet. Therefore, the Ertugliflozin to Reduce Arrhythmic burden in ICD ± CRT patientS (ERASe) trial was designed to investigate the efficacy and safety of ertugliflozin in patients with reduced and midrange ejection fraction (EF) with or without diabetes. Within a multicentre, national, randomized, double-blind, placebo-controlled, phase 3b trial we aim to enrol a total of 402 patients across Austria. Patients with reduced or midrange EF and ICD ± CRT therapy >3 months and previous ventricular tachycardia (at least 10 documented VT episodes within the last 12 months) are randomized in a 1:1 ratio to ertugliflozin (5 mg once daily orally administered) or matching placebo. The primary endpoint of the ERASe trial is to investigate the impact of ertugliflozin on total burden of ventricular arrhythmias. Further objectives will include number of therapeutic interventions of implanted devices, atrial fibrillation and heart failure biomarkers. The ERASe trial will be the first trial to test ertugliflozin in heart failure patients with nonpreserved ejection fraction and ongoing ICD ± CRT therapy regardless of their diabetic status. The ERASe trial may therefore extend the concept of SGLT2 inhibition to improve cardiac remodelling, including reduced arrhythmic burden. Trial registration Identifier EudraCT Nr. 2020-002581-14 / ClinicalTrials.gov Identifier: NCT04600921
ISSN:0002-8703
1097-6744
DOI:10.1016/j.ahj.2022.01.008