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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
55
The subject will receive Ertugliflozin 5mg orally once daily for 52 weeks.
The subject will receive Placebo 5mg orally daily for 52 weeks.
Klinikum Klagenfurt am Wörthersee
Klagenfurt, Carinthia, Austria
Kepler Universitätsklinikum Linz
Linz, Upper Austria, Austria
Medical University of Graz
Graz, Austria
Universitätsklinikum Innsbruck
Innsbruck, Austria
Ordensklinikum Linz Elisabethinen
Linz, Austria
Medizinische Universität Wien, AKH Wien
Vienna, Austria
Wilhelminenspital
Vienna, Austria
Landesklinikum Wiener Neustadt
Wiener Neustadt, Austria
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
Time frame: 52 weeks
Number of Nonsustained Ventricular Tachycardia (nsVT) Episodes
Number of nonsustained ventricular tachycardia (nsVT) episodes from baseline to week 52
Time frame: 52 weeks
Number of Episodes of Appropriate Implantable Cardioverter-defibrillator Therapies
Number of episodes of appropriate Implantable cardioverter-defibrillator therapies from baseline to week 52.
Time frame: 52 weeks
Change in NTproBNP Levels
Change in NTproBNP levels from baseline to week 52
Time frame: 52 weeks
Change in HbA1c Levels
Change in HbA1c levels from baseline to week 52
Time frame: 52 weeks
Number of Hospitalizations
Number of hospitalizations from baseline to week 56
Time frame: 56 weeks
Atleast One Hospitalization Due to Heart Failure
It is the number of patients with at least one hospital re-admission due to heart failure from baseline to 56 weeks
Time frame: 56 weeks
Number of Hospitalizations Due to Heart Failure
It is the number of hospital re-admissions due to heart failure from baseline to 56 weeks.
Time frame: 56 weeks
Duration of Hospital Stay
It is the number of days of hospital stay from baseline to 56 weeks
Time frame: 56 weeks
Cardiovascular Mortality
Difference in Cardiovascular mortality between treatment groups from randomisation to week 56
Time frame: 56 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.