Effect of Henagliflozin on Cardiac Function in Type 2 Diabetes Patients With Chronic Heart Failure: a Multicenter, Prospective, Pragmatic Randomized Controlled Trial
The purpose of this study is to determine the superiority of the effectiveness of Henagliflozin 10 milligram (mg) daily versus blank control in participants with type II diabetes (T2DM) and symptomatic heart failure (HF) in improving the overall Kansas City Cardiomyopathy Questionnaire (KCCQ) Clinical Summary Score (CSS).
• Patients with T2DM aged ≥18 years
• 6.5%≤HbA1c≤11%
• Clinically stable symptomatic heart failure
• (a) For HFrEF: (a) Ejection fraction (EF) less than or equal to (\<=) 40% and (b) diagnosis of chronic heart failure within the past 18 months (B) For HFpEF: (a) EF greater than (\>) 40%; (b) Diagnosis of chronic heart failure within the past 18 months
• Symptoms of heart failure at visit 1 (NYHA II-IV)
• KCCQ-OSS score \< 80 at screening visit
• NT-proBNP \> 125 pg/mL, or NT proBNP \> 365 pg/mL in atrial fibrillation patients; Or BNP \> 35 pg/mL, or BNP \> 105 pg/mL in atrial fibrillation patients at screening visit
• Subject must have received (and be receiving) at least one stable optimal dose of guidelines recommended HF drugs (e.g., ACEi, ARB, ARNI, beta blockers, oral diuretics, MRA) prior to visit 1
• eGFR≥30 ml/min/1.73m2 at screening visit (CKD-EPI formula)
• Signed and dated written ICF