Ignite Creation Date:
2024-05-06 @ 3:21 PM
Last Modification Date:
2024-10-26 @ 1:47 PM
Study NCT ID:
NCT04600921
Status:
TERMINATED
Last Update Posted:
2023-10-23
First Post:
2020-10-19
Brief Title:
Ertugliflozin to Reduce Arrhythmic Burden in ICDCRT patientS ERASe-Trial - a Phase III Study
Sponsor:
Medical University of Graz
Organization:
Medical University of Graz
Study Overview
Official Title:
Ertugliflozin to Reduce Arrhythmic Burden in Implantable Cardioverter-defibrillators ICDCardiac Resynchronisation TherapyCRT patientS ERASe-Trial - a Phase III Study
Status:
TERMINATED
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
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
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ERASE
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 po 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 ICDCRT 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None