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

Zhejiang University

Status: Enrolling

Conditions: Heart Failure

Treatments: Drug: blank control; Drug: Henagliflozin 10 mg

Study type: Interventional

Funder types: Other

Identifiers

NCT05742230

2022-1049

Details and patient eligibility

About

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).

Enrollment: 1,932 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• Pregnant and lactating women and women of childbearing age who do not want to use reliable contraception
• Known allergy to Henagliflozin
• Hospitalization for acute coronary syndrome, percutaneous coronary intervention, or cardiac surgery within 4 weeks before the screening visit
• Acute decompensated heart failure or hospitalization for decompensated heart failure within 4 weeks
• History of heart transplantation or ventricular assist device (VAD), or intention to heart transplantation or VAD
• Perinatal or chemotherapy-induced cardiomyopathy within 12 months
• Documented untreated ventricular arrhythmias with syncope within 3 months
• Diagnosed respiratory diseases
• Type I diabetes
• T2DM with history of ketoacidosis (DKA)
• Uncontrolled hypertension, defined as systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg at screening visit
• Symptomatic hypotension and/or systolic blood pressure <90 mmHg at visit 0 or visit 1, or hypovolemia
• History of recurrent urinary and reproductive tract infections
• Current use or prior use of a SGLT-2i or GLP-1RA within 3 months
• Diagnosed malignant tumors
• Further exclusion criteria apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,932 participants in 2 patient groups

Henagliflozin 10 mg

Experimental group

Description:

Single 10 mg tablet, administered orally once daily for 12 weeks

Treatment:

Drug: Henagliflozin 10 mg

blank control

Other group

Description:

standard treatment

Treatment:

Drug: blank control