NCT04600921

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

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

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 55 (actual)
• Sponsor: Medical University of Graz · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
DRUG	Ertugliflozin 5 mg	The subject will receive Ertugliflozin 5mg orally once daily for 52 weeks.
DRUG	Placebo 5mg	The subject will receive Placebo 5mg orally daily for 52 weeks.

Timeline

• Start date: 2021-06-24
• Primary completion: 2023-06-23
• Completion: 2023-10-18
• First posted: 2020-10-23
• Last updated: 2025-06-03
• Results posted: 2025-06-03

Locations

8 sites across 1 country: Austria