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

Conditions

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

Interventions

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.

Sponsors & Collaborators

• Klinikum Klagenfurt am Wörthersee

  collaborator OTHER

• Elisabethinen Hospital

  collaborator OTHER

• Medical University Innsbruck

  collaborator OTHER

• Medical University of Vienna

  collaborator OTHER

• General Hospital Linz

  collaborator OTHER

• Landesklinkum Wiener Neustadt

  collaborator OTHER

• Klinik Ottakring

  collaborator UNKNOWN

• Medical University of Graz

  lead OTHER

Principal Investigators

• Dirk von Lewinski, Assoc-Prof. · Medical University of Graz

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-06-24

Primary Completion

2023-06-23

Completion

2023-10-18

Countries

• Austria

Study Locations