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

Medical University of Graz

Status and phase: Terminated; Phase 3

Conditions: Implantable Cardioverter-Defibrillators; Cardiac Resynchronization Therapy; Heart Failure With Reduced Ejection Fraction; Heart Failure With Mid Range Ejection Fraction

Treatments: Drug: Placebo 5mg; Drug: Ertugliflozin 5 mg

Study type: Interventional

Funder types: Other

Identifiers

NCT04600921

DvL-2020-01

Details and patient eligibility

About

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.

Full description

This is a randomized, double-blind (patients and physicians), placebo controlled multi-center study to evaluate the effect of ertugliflozin 5mg once daily (p.o.) for 52 weeks on the ventricular arrhythmic burden and markers of physical and mental well-being as well as biomarker for Heart Failure with reduced Ejection Fraction (HFrEF) and heart failure with mid-range ejection fraction (HFmrEF) patients with ICD±CRT therapy. The study will be conducted in 8 experienced sites in Austria with an aim to enrol 402 patients to evaluate the overall study hypothesis.

Therefore, three study visits will be carried out (baseline, 1-year follow-up visit and a telephone visit 4 weeks after visit 2). As part of the two on-site study visits, study-specific measures, a blood sample and an echocardiographic examination will be performed. The trial is completed by a telephone visit 4 weeks after the second on-site visit (week 52).

It is anticipated that the study will run for 30 months.

Enrollment: 55 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

2. at least 10 documented VT episodes (either nsVT (non-sustained ventricular tachycardia) or sVT (sustained ventricular tachycardia) ± ICD (mplantable cardioverter-defibrillator) 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 (ventricular function) 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

55 participants in 2 patient groups, including a placebo group

Ertugliflozin

Active Comparator group

Description:

The subject will receive Ertugliflozin 5mg.

Treatment:

Drug: Ertugliflozin 5 mg

Placebo

Placebo Comparator group

Description:

The subject will receive Placebo 5mg.

Treatment:

Drug: Placebo 5mg