ERtugliflozin triAl in DIabetes With Preserved or Reduced ejeCtion FrAcTion mEchanistic Evaluation in Heart Failure

Inclusion Criteria

• Male or female subjects diagnosed with T2D ≥12 months prior to informed consent;
• eGFR ≥30 ml/min/1.73m2;
• Age >18 years;
• HbA1c 6.5%-10.5%;
• Body Mass Index (BMI) 18.5-45.0 kg/m2;
• Blood pressure ≤160/110 and ≥90/60 at screening,
• Heart failure with New York Heart Association (NYHA) class 2-3 symptoms and ejection fraction ≥20%
• Stable dose of maximally tolerated ACE inhibitor, angiotensin receptor blocker or renin inhibitor for at least 30 days
• Stable diuretic dose for at least 30 days at the time of baseline physiological assessment
• BNP levels at baseline ≥100 pg/ml (no atrial fibrillation), ≥200 pg/ml if in atrial fibrillation

Exclusion Criteria

• Type 1 Diabetes;
• Leukocyte and/or nitrite positive urinalysis that is untreated;
• Severe hypoglycaemia within 2 months prior to screening;
• History of brittle diabetes or hypoglycaemia unawareness based on investigator judgement;
• Unstable coronary artery disease with acute coronary syndrome, percutaneous intervention or bypass surgery within 3 months;
• Clinically significant valvular disease;
• Congestive heart failure secondary to an infiltrative cardiomyopathic process (for example amyloid) or pericardial constriction;
• Uncontrolled systemic hypertension (systolic blood pressure >160 mmHg and/or diastolic blood pressure >110) or systemic hypotension (systolic blood pressure 3 x upper limit of normal as determined during screening;
• Active malignancy at the time of screening;