Sodium-glucose Co-transporter 2 Inhibitors Effects in Failing Heart Patients
Status:
Completed
Trial end date:
2019-03-01
Target enrollment:
Participant gender:
Summary
SLGT2 therapy is safety used in heart failure (HF) patients with depressed left ventricle
ejection fraction (LVEF) and diabetes mellitus (DM). These patients experience higher rate of
ventricular arrhythmias (VA), that are a leading cause of cardiac arrest and mortality.
However, these patients are treated by implantable cardioverter defibrillator (ICD) and
cardiac resynchronization with defbrillator devices (CRTd) implant. In this setting, the
catheter ablation (CA) treatment has been used to reduce the ventricular arrhythmias and the
ICD/CRTds' interventions, and to prevent mortality events in these' patients. On other hand,
still a higher percentage of patients result as non responders to an ablative approach with
higher acute and long term mortality rate. Therefore, in the present study in a population of
HF patients (DM vs. non DM patients) affected by VA, authors will investigate the effects of
CA on mortality rate at 12 months of follow up. In addition, authors would demonstrate the
ameliorative effects of new hypoglycemic drugs in addition to CA in patients with DM.
However, after CA the patients with DM will be randomly assigned to SGLT2 therapy vs.
placebo. Indeed, study hypothesis will be that, a) DM vs. non DM patients might have higher
mortality rate after CA; b) patients with DM treated by CA plus SLGT2 therapy vs. patients
with DM treated by CA plus placebo might experience a lower rate of mortality at 1 year of
follow-up.