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

Primary Purpose

Heart Failure With Reduced Ejection Fraction, Heart Failure With Mid Range Ejection Fraction, Implantable Cardioverter-Defibrillators

Status
Terminated
Phase
Phase 3
Locations
Austria
Study Type
Interventional
Intervention
Ertugliflozin 5 mg
Placebo 5mg
Sponsored by
Medical University of Graz
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure With Reduced Ejection Fraction focused on measuring Ertugliflozin, Sodium dependent glucose transporter-2 inhibitor (SGLT-2), Heart failure, ICD, CRT, ventricular tachycardia (VT)

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Klinikum Klagenfurt am Wörthersee
  • Kepler Universitätsklinikum Linz
  • Medical University of Graz
  • Universitätsklinikum Innsbruck
  • Ordensklinikum Linz Elisabethinen
  • Medizinische Universität Wien, AKH Wien
  • Wilhelminenspital
  • Landesklinikum Wiener Neustadt

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Ertugliflozin

Placebo

Arm Description

The subject will receive Ertugliflozin 5mg.

The subject will receive Placebo 5mg.

Outcomes

Primary Outcome Measures

Change in number of supraventricular tachycardia (svT)/ ventricular fibrillation (VF) episodes
Change in number of supraventricular tachycardia (svT)/ ventricular fibrillation (VF) episodes from baseline to week 52

Secondary Outcome Measures

Number of nonsustained ventricular tachycardia (nsVT) episodes
Number of nonsustained ventricular tachycardia (nsVT) episodes from baseline to week 52
Number of appropriate therapeutic ICD therapies
Number of appropriate therapeutic ICD therapies from baseline to week 52
Change in nt-proBNP levels
Change in nt-proBNP levels from baseline to week 52
Change of HbA1c
Change of HbA1c from baseline to week 52
Number of hospital re-admissions due to heart failure
Number of hospital re-admissions due to heart failure from baseline to week 56
Duration of hospital stay
Duration of hospital stay from baseline to week 56
Cardiovascular Mortality
Cardiovascular Mortality from baseline to week 56

Full Information

First Posted
October 19, 2020
Last Updated
October 18, 2023
Sponsor
Medical University of Graz
Collaborators
Klinikum Klagenfurt am Wörthersee, Elisabethinen Hospital, Medical University Innsbruck, Medical University of Vienna, General Hospital Linz, Landesklinkum Wiener Neustadt, Klinik Ottakring
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1. Study Identification

Unique Protocol Identification Number
NCT04600921
Brief Title
Ertugliflozin to Reduce Arrhythmic Burden in ICD/CRT patientS (ERASe-Trial) - a Phase III Study
Acronym
ERASE
Official Title
Ertugliflozin to Reduce Arrhythmic Burden in Implantable Cardioverter-defibrillators (ICD)/Cardiac Resynchronisation Therapy(CRT) patientS (ERASe-Trial) - a Phase III Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Terminated
Why Stopped
The feasibility (recruitment) of the high number of patients (402 patients with HFrEF or HFmrEF) was impossible due to the rapid increase in SGLT2 inhibitors in patients with heart failure.
Study Start Date
June 24, 2021 (Actual)
Primary Completion Date
June 23, 2023 (Actual)
Study Completion Date
October 18, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medical University of Graz
Collaborators
Klinikum Klagenfurt am Wörthersee, Elisabethinen Hospital, Medical University Innsbruck, Medical University of Vienna, General Hospital Linz, Landesklinkum Wiener Neustadt, Klinik Ottakring

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure With Reduced Ejection Fraction, Heart Failure With Mid Range Ejection Fraction, Implantable Cardioverter-Defibrillators, Cardiac Resynchronization Therapy
Keywords
Ertugliflozin, Sodium dependent glucose transporter-2 inhibitor (SGLT-2), Heart failure, ICD, CRT, ventricular tachycardia (VT)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
55 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ertugliflozin
Arm Type
Active Comparator
Arm Description
The subject will receive Ertugliflozin 5mg.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
The subject will receive Placebo 5mg.
Intervention Type
Drug
Intervention Name(s)
Ertugliflozin 5 mg
Other Intervention Name(s)
Steglatro
Intervention Description
The subject will receive Ertugliflozin 5mg orally once daily for 52 weeks.
Intervention Type
Drug
Intervention Name(s)
Placebo 5mg
Other Intervention Name(s)
Sugar pills
Intervention Description
The subject will receive Placebo 5mg orally daily for 52 weeks.
Primary Outcome Measure Information:
Title
Change in number of supraventricular tachycardia (svT)/ ventricular fibrillation (VF) episodes
Description
Change in number of supraventricular tachycardia (svT)/ ventricular fibrillation (VF) episodes from baseline to week 52
Time Frame
52 weeks
Secondary Outcome Measure Information:
Title
Number of nonsustained ventricular tachycardia (nsVT) episodes
Description
Number of nonsustained ventricular tachycardia (nsVT) episodes from baseline to week 52
Time Frame
52 weeks
Title
Number of appropriate therapeutic ICD therapies
Description
Number of appropriate therapeutic ICD therapies from baseline to week 52
Time Frame
52 weeks
Title
Change in nt-proBNP levels
Description
Change in nt-proBNP levels from baseline to week 52
Time Frame
52 weeks
Title
Change of HbA1c
Description
Change of HbA1c from baseline to week 52
Time Frame
52 weeks
Title
Number of hospital re-admissions due to heart failure
Description
Number of hospital re-admissions due to heart failure from baseline to week 56
Time Frame
56 weeks
Title
Duration of hospital stay
Description
Duration of hospital stay from baseline to week 56
Time Frame
56 weeks
Title
Cardiovascular Mortality
Description
Cardiovascular Mortality from baseline to week 56
Time Frame
56 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: HFrEF or HFmrEF, and ICD±CRT therapy > 3 months 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 Informed consent has to be given in written form. estimated glomerular filtration rate (eGFR) > 30 ml/min/1.73m2 Blood pressure before first drug dosing: blood pressure systolic > 100 mmHg Blood pressure before first drug dosing: blood pressure diastolic > 60 mmHg Exclusion Criteria: Any other form of diabetes mellitus than type 2 diabetes mellitus, history of diabetic ketoacidosis Ongoing ventricular arrhythmia Known allergy to SGLT-2 inhibitors Haemodynamic instability as defined by intravenous administration of catecholamine, calciumsensitizers or phosphodiesterase inhibitors >1 episode of severe hypoglycemia within the last 6 months under treatment with insulin or sulfonylurea Planned catheter ablation for ventricular arrhythmia Planned explantation of ICD, or planned up/downgrade to/from CRT-D device Existing therapy with SGLT-2 inhibitors
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dirk von Lewinski, Assoc-Prof.
Organizational Affiliation
Medical University of Graz
Official's Role
Principal Investigator
Facility Information:
Facility Name
Klinikum Klagenfurt am Wörthersee
City
Klagenfurt
State/Province
Kärnten
ZIP/Postal Code
9020
Country
Austria
Facility Name
Kepler Universitätsklinikum Linz
City
Linz
State/Province
Oberösterreich
ZIP/Postal Code
4021
Country
Austria
Facility Name
Medical University of Graz
City
Graz
ZIP/Postal Code
8010
Country
Austria
Facility Name
Universitätsklinikum Innsbruck
City
Innsbruck
ZIP/Postal Code
620
Country
Austria
Facility Name
Ordensklinikum Linz Elisabethinen
City
Linz
ZIP/Postal Code
4020
Country
Austria
Facility Name
Medizinische Universität Wien, AKH Wien
City
Vienna
ZIP/Postal Code
1090
Country
Austria
Facility Name
Wilhelminenspital
City
Vienna
ZIP/Postal Code
1160
Country
Austria
Facility Name
Landesklinikum Wiener Neustadt
City
Wiener Neustadt
ZIP/Postal Code
2700
Country
Austria

12. IPD Sharing Statement

Citations:
PubMed Identifier
35045327
Citation
von Lewinski D, Tripolt NJ, Sourij H, Pferschy PN, Oulhaj A, Alber H, Gwechenberger M, Martinek M, Seidl S, Moertl D, Nurnberg M, Roithinger FX, Steinwender C, Stuhlinger M, Zirlik A, Benedikt M, Kolesnik E, Wallner M, Rohrer U, Manninger M, Scherr D; ERASe study group. Ertugliflozin to reduce arrhythmic burden in ICD/CRT patients (ERASe-trial) - A phase III study. Am Heart J. 2022 Apr;246:152-160. doi: 10.1016/j.ahj.2022.01.008. Epub 2022 Jan 16.
Results Reference
derived

Learn more about this trial

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

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