Heart failure
Conditions
Interventions
Trade Name: Steglatro (Ertugliflozin)
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: ERTUGLIFLOZIN
CAS Number: 1210344-57-2
Current Sponsor code: MK8835
Other descriptive name: Steglatro
Sponsors
Medical University of Graz, Division of Cardiology
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) HFrEF or HFmrEF and ICD±CRT therapy > 3 months 2) Least 10 documented VT episodes (either nsVT or sVT ± ICD treatment) within the last 12 months plus - nt-proBNP > 500pg/mL or - LV-EF 100nsVTs within the last 12 months- > 1 sVT/VF within the last 12 months 3) Informed consent has to be given in written form. 4) eGFR > 30 ml/min/1.73m2 5) Blood pressure before first drug dosing: RRsystolic >100mmHg 6) Blood pressure before first drug dosing: RRdiastolic >60mmHg 7) 18 – 80 years of age Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 201 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 201
Exclusion criteria
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) Hemodynamic instability as defined by intravenous administration of catecholamine, calcium-sensitizers 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 within upcoming 12 months 7) Planned explantation of ICD, or planned up/downgrade to/from CRT-D device within upcoming 12 months 8) Existing therapy with SGLT-2 inhibitors
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to investigate the impact of ertugliflozin on ventricular arrhythmia burden. ;Secondary Objective: Further objectives will be the number of therapeutic interventions of implanted devices, atrial fibrillation, heart failure biomarker and changes in physical function.;Primary end point(s): Difference in number of sVT/VF episodes between treatment groups from randomization to week 52;Timepoint(s) of evaluation of this end point: Baseline and week 52 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Difference in nsVT episodes between treatment groups from randomization to week 52 Difference in number of appropriate therapeutic ICD therapies between groups from randomization to week 52 Difference in the change of nt-proBNP levels between treatment groups from randomization to week 52 Difference in the change of HbA1c between treatment groups from randomization to week 52 (in subjects with known T2DM) Difference in the number of hospital re-admissions due to heart failure between the treatment groups Difference in the duration of hospital stay between the treatment groups after initiation of the study treatment Difference in cardiovascular mortality between treatment groups from randomization to week 52 ;Timepoint(s) of evaluation of this end point: Baseline and week 52 | — |
Countries
Austria
Contacts
Public ContactDirk von Lewinski
Medical University of Graz
Outcome results
None listed