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

Heart Failure With Reduced Ejection Fraction Clinical Trial

— ERASE  

Official title:

Ertugliflozin to Reduce Arrhythmic Burden in Implantable Cardioverter-defibrillators (ICD)/Cardiac Resynchronisation Therapy(CRT) patientS (ERASe-Trial) - a Phase III Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04600921
• Other study ID #: DvL-2020-01
• Status: Terminated
• Phase: Phase 3
• Start date: June 24, 2021
• Est. completion date: October 18, 2023

Study information

• Verified date: October 2023
• Source: Medical University of Graz
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 55
• Est. completion date: October 18, 2023
• Est. primary completion date: June 23, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiac Resynchronization Therapy
• Heart Failure
• Heart Failure With Mid Range Ejection Fraction
• Heart Failure With Reduced Ejection Fraction
• Implantable Cardioverter-Defibrillators

Intervention

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

Locations

Country	Name	City	State
Austria	Medical University of Graz	Graz
Austria	Universitätsklinikum Innsbruck	Innsbruck
Austria	Klinikum Klagenfurt am Wörthersee	Klagenfurt	Kärnten
Austria	Kepler Universitätsklinikum Linz	Linz	Oberösterreich
Austria	Ordensklinikum Linz Elisabethinen	Linz
Austria	Medizinische Universität Wien, AKH Wien	Vienna
Austria	Wilhelminenspital	Vienna
Austria	Landesklinikum Wiener Neustadt	Wiener Neustadt

Sponsors (8)

Lead Sponsor	Collaborator
Medical University of Graz	Elisabethinen Hospital, General Hospital Linz, Klinik Ottakring, Klinikum Klagenfurt am Wörthersee, Landesklinkum Wiener Neustadt, Medical University Innsbruck, Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	52 weeks
Secondary	Number of nonsustained ventricular tachycardia (nsVT) episodes	Number of nonsustained ventricular tachycardia (nsVT) episodes from baseline to week 52	52 weeks
Secondary	Number of appropriate therapeutic ICD therapies	Number of appropriate therapeutic ICD therapies from baseline to week 52	52 weeks
Secondary	Change in nt-proBNP levels	Change in nt-proBNP levels from baseline to week 52	52 weeks
Secondary	Change of HbA1c	Change of HbA1c from baseline to week 52	52 weeks
Secondary	Number of hospital re-admissions due to heart failure	Number of hospital re-admissions due to heart failure from baseline to week 56	56 weeks
Secondary	Duration of hospital stay	Duration of hospital stay from baseline to week 56	56 weeks
Secondary	Cardiovascular Mortality	Cardiovascular Mortality from baseline to week 56	56 weeks