Device-Derived Digital Biomarkers During SGLT2 Inhibitor Therapy: A Secondary Analysis of the ERASe Trial
4 affiliations
- 1Department of Internal Medicine, Division of Cardiology, Medical University of Graz, Auenbruggerplatz 15, 8036 Graz, Austria
- 2University Clinic of Internal Medicine III/Cardiology and Angiology, Medical University of Innsbruck, Anichstraße 35, 6020 Innsbruck, Austria
- 3Department of Internal Medicine, Division of Endocrinology and Diabetology, Medical University of Graz, Auenbruggerplatz 15, 8036 Graz, Austria
- 4Cardiometabolic Trials Unit, Medical University of Graz, Auenbruggerpl. 2/9, 8036 Graz, Austria
Abstract
Aims: Implantable cardioverter-defibrillators (ICD) and cardiac resynchronization therapy defibrillators (CRT-D) provide continuous physiological data reflecting heart failure (HF) status and autonomic tone. Sodium–glucose cotransporter-2 inhibitors (SGLT2i) are core HF therapy, but it remains unclear whether their physiological effects are detectable using device-based remote monitoring. Following the ERASe trial, which showed reduced ventricular arrhythmias with ertugliflozin, this post-hoc analysis evaluated its impact on ICD/CRT-D-derived parameters. Methods: In this prospective, randomized ERASe post-hoc analysis, ertugliflozin was compared with placebo over 12 months in patients with ICD or CRT-D devices. Device-derived parameters including 24 h heart rate, night heart rate, heart rate variability, physical activity, and thoracic impedance were assessed at baseline and follow-up. Analyses were predefined as exploratory. Results: Forty-six patients (22 ertugliflozin, 24 placebo) had ≥1 analysable parameter. Paired longitudinal data were available for 29 patients for 24 h heart rate (HR), 19 for night HR, 17 for HR variability, and 9 for thoracic impedance. No significant between-group differences were observed in 24 h HR, physical activity or thoracic impedance. No significant differential longitudinal treatment effects were observed for the evaluated device-derived parameters, although estimates were imprecise because of limited parameter-specific data availability. Assessment of associations with arrhythmic and heart-failure outcomes was precluded by small event numbers and incomplete parameter-specific data. Conclusions: Ertugliflozin did not significantly alter individual device-derived parameters. Larger studies are needed to determine whether device-based physiological signals can identify treatment-related changes.
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BibTeX
@article{rohrer2026devicederived,
title = {{Device-Derived Digital Biomarkers During SGLT2 Inhibitor Therapy: A Secondary Analysis of the ERASe Trial}},
author = {Ursula Rohrer and Katharina Ingrid Gölly and Martin Benedikt and Viktoria Santner and Martin Manninger and Simon Leiter and Johannes Widkal and Markus Stühlinger and Lukas Herold and Andreas Zirlik and Harald Sourij and Dirk von Lewinski and Daniel Scherr},
journal = {Journal of Clinical Medicine},
year = {2026},
month = oct,
doi = {10.3390/jcm15218441},
url = {https://www.mdpi.com/2077-0383/15/21/8441},
note = {CC BY 4.0},
}
RIS
TY - JOUR
TI - Device-Derived Digital Biomarkers During SGLT2 Inhibitor Therapy: A Secondary Analysis of the ERASe Trial
AU - Ursula Rohrer
AU - Katharina Ingrid Gölly
AU - Martin Benedikt
AU - Viktoria Santner
AU - Martin Manninger
AU - Simon Leiter
AU - Johannes Widkal
AU - Markus Stühlinger
AU - Lukas Herold
AU - Andreas Zirlik
AU - Harald Sourij
AU - Dirk von Lewinski
AU - Daniel Scherr
PY - 2026
DA - 2026/10/29
JO - Journal of Clinical Medicine
DO - 10.3390/jcm15218441
UR - https://www.mdpi.com/2077-0383/15/21/8441
AB - Aims: Implantable cardioverter-defibrillators (ICD) and cardiac resynchronization therapy defibrillators (CRT-D) provide continuous physiological data reflecting heart failure (HF) status and autonomic tone. Sodium–glucose cotransporter-2 inhibitors (SGLT2i) are core HF therapy, but it remains unclear whether their physiological effects are detectable using device-based remote monitoring. Following the ERASe trial, which showed reduced ventricular arrhythmias with ertugliflozin, this post-hoc analysis evaluated its impact on ICD/CRT-D-derived parameters. Methods: In this prospective, randomized ERASe post-hoc analysis, ertugliflozin was compared with placebo over 12 months in patients with ICD or CRT-D devices. Device-derived parameters including 24 h heart rate, night heart rate, heart rate variability, physical activity, and thoracic impedance were assessed at baseline and follow-up. Analyses were predefined as exploratory. Results: Forty-six patients (22 ertugliflozin, 24 placebo) had ≥1 analysable parameter. Paired longitudinal data were available for 29 patients for 24 h heart rate (HR), 19 for night HR, 17 for HR variability, and 9 for thoracic impedance. No significant between-group differences were observed in 24 h HR, physical activity or thoracic impedance. No significant differential longitudinal treatment effects were observed for the evaluated device-derived parameters, although estimates were imprecise because of limited parameter-specific data availability. Assessment of associations with arrhythmic and heart-failure outcomes was precluded by small event numbers and incomplete parameter-specific data. Conclusions: Ertugliflozin did not significantly alter individual device-derived parameters. Larger studies are needed to determine whether device-based physiological signals can identify treatment-related changes.
SN - 2077-0383
ER -