TY - JOUR
T1 - Ertugliflozin to reduce arrhythmic burden in ICD/CRT patients (ERASe-trial) - A phase III study
AU - ERASe study group
AU - von Lewinski, Dirk
AU - Tripolt, Norbert J
AU - Sourij, Harald
AU - Pferschy, Peter N
AU - Oulhaj, Abderrahim
AU - Alber, Hannes
AU - Gwechenberger, Marianne
AU - Martinek, Martin
AU - Seidl, Sebastian
AU - Moertl, Deddo
AU - Nürnberg, Michael
AU - Roithinger, Franz Xaver
AU - Steinwender, Clemens
AU - Stühlinger, Markus
AU - Zirlik, Andreas
AU - Benedikt, Martin
AU - Kolesnik, Ewald
AU - Wallner, Markus
AU - Rohrer, Ursula
AU - Manninger, Martin
AU - Scherr, Daniel
N1 - Funding Information:
Supported in part by a research grant from the Investigators Studies Research Program of Merck Sharp & Dohme Corp in collaboration with Pfizer. Funding included providing study medication and monetary support. The authors are solely responsible for the design and conduct of this trial, all study analyses, and drafting and editing of the paper. The opinions expressed in this paper are those of the investigators and do not necessarily represent those Merck Sharp & Dohme Corp or Pfizer.
Publisher Copyright:
© 2022 The Authors
PY - 2022/4
Y1 - 2022/4
N2 - 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. METHODS: 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. CONCLUSION: 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.
AB - 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. METHODS: 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. CONCLUSION: 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.
KW - Bridged Bicyclo Compounds, Heterocyclic/therapeutic use
KW - Defibrillators, Implantable
KW - Double-Blind Method
KW - Heart Failure/drug therapy
KW - Humans
KW - Stroke Volume/physiology
KW - Treatment Outcome
KW - Ventricular Function, Left/physiology
UR - http://www.scopus.com/inward/record.url?scp=85123797150&partnerID=8YFLogxK
U2 - 10.1016/j.ahj.2022.01.008
DO - 10.1016/j.ahj.2022.01.008
M3 - Journal article
C2 - 35045327
SN - 0002-8703
VL - 246
SP - 152
EP - 160
JO - American Heart Journal
JF - American Heart Journal
ER -