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

Last updated: May 14, 2025
Sponsor: Medical University of Graz
Overall Status: Terminated

Phase

3

Condition

Heart Failure

Hyponatremia

Chest Pain

Treatment

Ertugliflozin 5 mg

Placebo 5mg

Clinical Study ID

NCT04600921
DvL-2020-01
  • Ages 18-80
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

  2. at least 10 documented VT episodes (either nsVT (non-sustained ventriculartachycardia) or sVT (sustained ventricular tachycardia) ± ICD (mplantablecardioverter-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

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

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

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

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

Exclusion

Exclusion Criteria:

  1. Any other form of diabetes mellitus than type 2 diabetes mellitus, history ofdiabetic 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 withinsulin 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

Study Design

Total Participants: 55
Treatment Group(s): 2
Primary Treatment: Ertugliflozin 5 mg
Phase: 3
Study Start date:
June 24, 2021
Estimated Completion Date:
October 18, 2023

Study 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.

Connect with a study center

  • Klinikum Klagenfurt am Wörthersee

    Klagenfurt, Kärnten 9020
    Austria

    Site Not Available

  • Kepler Universitätsklinikum Linz

    Linz, Oberösterreich 4021
    Austria

    Site Not Available

  • Medical University of Graz

    Graz, 8010
    Austria

    Site Not Available

  • Universitätsklinikum Innsbruck

    Innsbruck, 620
    Austria

    Site Not Available

  • Ordensklinikum Linz Elisabethinen

    Linz, 4020
    Austria

    Site Not Available

  • Universitätsklinikum St. Pölten

    St. Pölten, 3100
    Austria

    Site Not Available

  • Medizinische Universität Wien, AKH Wien

    Vienna, 1090
    Austria

    Site Not Available

  • Wilhelminenspital

    Vienna, 1160
    Austria

    Site Not Available

  • Landesklinikum Wiener Neustadt

    Wiener Neustadt, 2700
    Austria

    Site Not Available

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