Effect of Henagliflozin on Cardiac Function in Type 2 Diabetes Patients With Chronic Heart Failure (HERO-HF)

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).

Inclusion Criteria:Patients with T2DM aged ≥18 years6.5%≤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 monthsSymptoms of heart failure at visit 1 (NYHA II-IV)KCCQ-OSS score < 80 at screening visitNT-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 visitSubject 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 1eGFR≥30 ml/min/1.73m2 at screening visit (CKD-EPI formula)Signed and dated written ICFExclusion Criteria:Pregnant and lactating women and women of childbearing age who do not want to use reliable contraceptionKnown allergy to HenagliflozinHospitalization for acute coronary syndrome, percutaneous coronary intervention, or cardiac surgery within 4 weeks before the screening visitAcute decompensated heart failure or hospitalization for decompensated heart failure within 4 weeksHistory of heart transplantation or ventricular assist device (VAD), or intention to heart transplantation or VADPerinatal or chemotherapy-induced cardiomyopathy within 12 monthsDocumented untreated ventricular arrhythmias with syncope within 3 monthsDiagnosed respiratory diseasesType I diabetesT2DM with history of ketoacidosis (DKA)Uncontrolled hypertension, defined as systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg at screening visitSymptomatic hypotension and/or systolic blood pressure <90 mmHg at visit 0 or visit 1, or hypovolemiaHistory of recurrent urinary and reproductive tract infectionsCurrent use or prior use of a SGLT-2i or GLP-1RA within 3 monthsDiagnosed malignant tumorsFurther exclusion criteria apply