Ertugliflozin to Reduce Arrhythmic Burden in ICD/CRT patientS (ERASe-Trial) - a Phase III Study

• Status: Recruiting
• Trial end date: 2024-01-06
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Medical University of Graz
• Collaborators: Elisabethinen Hospital; General Hospital Linz; Klinik Ottakring; Klinikum Klagenfurt am Wörthersee; Klinikum Wiener Neustadt; Medical University Innsbruck; Medical University of Vienna; Wilhelminenspital Vienna
• Treatments: 5-(4-chloro-3-(4-ethoxybenzyl)phenyl)-1-hydroxymethyl-6,8-dioxabicyclo(3.2.1)octane-2,3,4-triol; Ertugliflozin

Criteria

Inclusion Criteria:

1. HFrEF or HFmrEF, and ICD±CRT therapy > 3 months

2. at least 10 documented VT episodes (either nsVT or sVT ± ICD treatment) within the last 12 months plus:

• nt-proBNP > 500pg/mL or

• Left-ventricular Ejection Fraction (LV-EF) < 35% or

• hospitalization for heart failure within the last 12 months or

• > 100 nsVTs within the last 12 months

• > 1 sVT/VF within the last 12 months

3. Informed consent has to be given in written form.

4. estimated glomerular filtration rate (eGFR) > 30 ml/min/1.73m2

5. Blood pressure before first drug dosing: blood pressure systolic > 100 mmHg

6. Blood pressure before first drug dosing: blood pressure diastolic > 60 mmHg

Exclusion Criteria:

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. Haemodynamic instability as defined by intravenous administration of catecholamine, calciumsensitizers 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

7. Planned explantation of ICD, or planned up/downgrade to/from CRT-D device

8. Existing therapy with SGLT-2 inhibitors