Sodium-glucose Co-transporter 2 Inhibitors Effects in Failing Heart Patients
Condition: Diabetes Mellitus; Heart Failure; Ventricular Arrythmia
MeSH terms: Arrhythmias, Cardiac; Diabetes Mellitus
Study type: Interventional
Phase: Phase 4

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.
    

Detailed description: 
      SLGT2 therapy is safety used in heart failure (HF) patients with depressed left ventricle
      ejection fraction (LVEF) and diabetes mellitus (DM). Indeed, in these patients SGLT2 therapy
      reduces hospital admission for heart failure and mortality rate. To date, these patients
      experience higher rate of ventricular arrhythmias (VA), that are a leading cause of cardiac
      arrest and mortality. However, as indicated by international guidelines, these patients can
      be treated by implantable cardioverter defibrillator (ICD) and CRTd as primary and/or
      secondary prevention therapy. Consequently, the effectiveness of ICD and CRTd is to treat
      sustained VA, and to reduce cardiac arrest events and mortality. Indeed, ICDs/CRTds'
      anti-tachycardia pacing and shocks can interrupt VA, and this might prevent a cardiac arrest
      event. This therapeutic effect can positively impact on acute and long term patients'
      survival. On other hand, authors showed that, continuous VA events and ICDs' interventions
      are causes of reduced patients' life expectancy in HF patients. This worse prognosis is
      particularly evidenced in failing heart patients with DM as compared to patients without DM.
      In this setting, the catheter ablation (CA) treatment has been used to reduce the ventricular
      arrhythmias and the ICDs/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. Among these non responders
      patients to an ablative approach, DM is a negative prognostic factor. Therefore, in the
      present study in a population of HF patients (DM vs. non DM patients) with VA authors will
      investigate the effects of CA on mortality rate at 12 months of follow up. In addition,
      authors would like to 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 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. Therefore, study aim will be to demonstrate a reduction of
      VA, ICDs/CRTds' interventions, and mortality in patients with DM treated by CA plus SLGT2
      therapy vs. patients with DM treated by CA plus placebo at 12 months of follow-up.
    

Intervention name(s): SLGT2; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): These patients will receive SLGT2 therapy after catheter ablation.; These patients will receive placebo therapy after catheter ablation.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention