Effects of empagliflozin on cardiac remodeling and myocardial sympathetic nervous system in diabetic patients affected by chronic heart failure

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Effectiveness study (incl. comparative)

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  EMPAGLIFLOZIN
• Medical condition to be studied:
  Chronic left ventricular failure

  Type 2 diabetes mellitus

Population studied

• Age groups:
  • Adult and elderly population (≥18 years)

    • Adults (18 to < 65 years)

      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)
    • Elderly (≥ 65 years)

      • Adults (65 to < 75 years)
• Estimated number of subjects:
  34

Study design details

• Main study objective:
  The primary endpoint is to assess the effect of empagliflozin on left ventricular remodeling and function and on biomarkers of HF hemodynamic status. Secondary endpoint is to assess the effects of empagliflozin on myocardial sympathetic nervous system activity.
• Outcomes:
  The primary endpoint is to assess the effect of empagliflozin on left ventricular remodeling and function and on biomarkers of HF hemodynamic status. Secondary endpoint is to assess the effects of empagliflozin on myocardial sympathetic nervous system activity.
• Data analysis plan:
  Prospective cohort study. Patients will receive empagliflozin according to diabetologists’ prescription. Endpoints will be evaluated by in each study procedure by two investigators blinded to personal patients’ data and treatment allocation.