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

Sponsor
Medical University of Graz (Other)
Overall Status
Recruiting
CT.gov ID
NCT04600921
Collaborator
Klinikum Klagenfurt am Wörthersee (Other), Elisabethinen Hospital (Other), Klinik Ottakring (Other), Medical University Innsbruck (Other), Medical University of Vienna (Other), General Hospital Linz (Other), Landesklinkum Wiener Neustadt (Other)
402
Enrollment
9
Locations
2
Arms
35.2
Anticipated Duration (Months)
44.7
Patients Per Site
1.3
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Ertugliflozin 5 mg
  • Drug: Placebo 5mg
 Phase 3

Detailed 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
402 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Ertugliflozin to Reduce Arrhythmic Burden in Implantable Cardioverter-defibrillators (ICD)/Cardiac Resynchronisation Therapy(CRT) patientS (ERASe-Trial) - a Phase III Study
Actual Study Start Date :
Jun 24, 2021
Anticipated Primary Completion Date :
Apr 30, 2024
Anticipated Study Completion Date :
May 30, 2024

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Ertugliflozin

The subject will receive Ertugliflozin 5mg.

Drug: Ertugliflozin 5 mg
The subject will receive Ertugliflozin 5mg orally once daily for 52 weeks.
Other Names:
  • Steglatro

    		•
    Placebo Comparator: Placebo

    The subject will receive Placebo 5mg.

    Drug: Placebo 5mg
    The subject will receive Placebo 5mg orally daily for 52 weeks.
    Other Names:
  • Sugar pills

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Change in number of supraventricular tachycardia (svT)/ ventricular fibrillation (VF) episodes [52 weeks]

    Secondary Outcome Measures

    1. Number of nonsustained ventricular tachycardia (nsVT) episodes [52 weeks]

    2. Number of appropriate therapeutic ICD therapies [52 weeks]

    3. Change in nt-proBNP levels [52 weeks]

    4. Change of HbA1c [52 weeks]

    5. Number of hospital re-admissions due to heart failure [56 weeks]

    6. Duration of hospital stay [56 weeks]

    7. Cardiovascular Mortality [56 weeks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    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 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Klinikum Klagenfurt am Wörthersee Klagenfurt Kärnten Austria 9020
    2 Kepler Universitätsklinikum Linz Linz Oberösterreich Austria 4021
    3 Medical University of Graz Graz Austria 8010
    4 Universitätsklinikum Innsbruck Innsbruck Austria 620
    5 Ordensklinikum Linz Elisabethinen Linz Austria 4020
    6 Universitätsklinikum St. Pölten St. Pölten Austria 3100
    7 Medizinische Universität Wien, AKH Wien Vienna Austria 1090
    8 Wilhelminenspital Vienna Austria 1160
    9 Landesklinikum Wiener Neustadt Wiener Neustadt Austria 2700

    Sponsors and Collaborators

    • Medical University of Graz
    • Klinikum Klagenfurt am Wörthersee
    • Elisabethinen Hospital
    • Klinik Ottakring
    • Medical University Innsbruck
    • Medical University of Vienna
    • General Hospital Linz
    • Landesklinkum Wiener Neustadt

    Investigators

    • Principal Investigator: Dirk von Lewinski, Assoc-Prof., Medical University of Graz

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Medical University of Graz
    ClinicalTrials.gov Identifier:
    NCT04600921
    Other Study ID Numbers:
    • DvL-2020-01
    First Posted:
    Oct 23, 2020
    Last Update Posted:
    Feb 1, 2022
    Last Verified:
    Jan 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Medical University of Graz
    Ertugliflozin
    Sodium dependent glucose transporter-2 inhibitor (SGLT-2)
    Heart failure
    ICD
    CRT
    ventricular tachycardia (VT)
    Additional relevant MeSH terms:
    Heart Failure
    Ertugliflozin

    Study Results

    No Results Posted as of Feb 1, 2022