drugset / Trial / NCT04600921
Ertugliflozin to Reduce Arrhythmic Burden in ICD/CRT patientS (ERASe-Trial) - a Phase III Study
Phase 3
Terminated
55 enrolled
Medical University of Graz
Elisabethinen Hospital · collabGeneral Hospital Linz · collabKlinik Ottakring · collabKlinikum Klagenfurt am Wörthersee · collabLandesklinkum Wiener Neustadt · collabMedical University Innsbruck · collabMedical University of Vienna · collab
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The recent study is planned to investigate the impact of Ertugliflozin on total burden of ventricular arrhythmias. Further objectives will be number of therapeutic interventions of implanted devices, atrial fibrillation, heart failure biomarker and changes in physical function quality of life, stress and anxiety.
Timeline
- Start
- 2021-06-24
- Primary completion
- 2023-06-23
- Completion
- 2023-10-18
Publications
- Benedikt M, Oulhaj A, Rohrer U, Manninger M, Tripolt NJ, Pferschy PN, Aziz F, Wallner M, Kolesnik E, Gwechenberger M, Martinek M, Nurnberg M, Roithinger FX, Steinwender C, Widkal J, Leiter S, Zirlik A, Stuhlinger M, Scherr D, Sourij H, von Lewinski D. Ertugliflozin to Reduce Arrhythmic Burden in Patients with ICDs/CRT-Ds. NEJM Evid. 2024 Oct;3(10):EVIDoa2400147. doi: 10.1056/EVIDoa2400147. Epub 2024 Sep 1.
- von Lewinski D, Tripolt NJ, Sourij H, Pferschy PN, Oulhaj A, Alber H, Gwechenberger M, Martinek M, Seidl S, Moertl D, Nurnberg M, Roithinger FX, Steinwender C, Stuhlinger M, Zirlik A, Benedikt M, Kolesnik E, Wallner M, Rohrer U, Manninger M, Scherr D; ERASe study group. Ertugliflozin to reduce arrhythmic burden in ICD/CRT patients (ERASe-trial) - A phase III study. Am Heart J. 2022 Apr;246:152-160. doi: 10.1016/j.ahj.2022.01.008. Epub 2022 Jan 16.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Ertugliflozin | Unknown | 5 mg | Oral |