Ertugliflozin to Reduce Arrhythmic burden in ICD/CRT patientS (ERASe-Trial) – a phase III Study - ERASe-Trial

Medical University of Graz, Division of Cardiology0 个研究点目标入组 402 人开始时间: 2020年9月2日最近更新: 2021年10月8日

适应症

试验速览

暂无简介。

•1) HFrEF or HFmrEF and ICD±CRT therapy > 3 months
•2) Least 10 documented VT episodes (either nsVT or sVT ± ICD treatment) within the last 12 months plus
•- nt-proBNP > 500pg/mL or
•- LV-EF < 35% or
•- hospitalization for heart failure within the last 12 months or
•- >100nsVTs within the last 12 months- > 1 sVT/VF within the last 12 months
•3) Informed consent has to be given in written form.
•4) eGFR > 30 ml/min/1.73m2
•5) Blood pressure before first drug dosing: RRsystolic >100mmHg
•6) Blood pressure before first drug dosing: RRdiastolic >60mmHg
•7) 18 – 80 years of age
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 201
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 201

•1) Any other form of diabetes mellitus than type 2 diabetes mellitus, history of diabetic ketoacidosis
•2) Ongoing ventricular arrhythmia
•3) Known allergy to SGLT-2 inhibitors
•4) Hemodynamic instability as defined by intravenous administration of catecholamine, calcium-sensitizers or phosphodiesterase inhibitors
•5) >1 episode of severe hypoglycemia within the last 6 months under treatment with insulin or sulfonylurea
•6) Planned catheter ablation for ventricular arrhythmia within upcoming 12 months
•7) Planned explantation of ICD, or planned up/downgrade to/from CRT-D device within upcoming 12 months
•8) Existing therapy with SGLT-2 inhibitors

发起方

Medical University of Graz, Division of Cardiology