SGLT2 Inhibitors and Treatment of Heart Failure in Severe Renal Insufficiency

In the treatment of heart failure (HF), SGLT-2 inhibitor (SGLT-2i) can significantly improve the clinical outcome and quality of life related to HF. The current data show that SGLT-2i is effective and safe in improving HF outcomes in patients with CKD stage 4, but there is little clinical evidence in patients with eGFR<20 ml/min/1.73 m2. Therefore, our research is designed to confirm that SGLT2i can improve the outcome of HF in patients with chronic heart failure with reduced ejection fraction (HFrEF) and chronic renal insufficiency (eGFR<20ml/min/1.73m2).

Inclusion Criteria:Age 20-75 yearsPatients with clinically confirmed chronic heart failure who have received treatment for heart failure according to the guidelines in the past two months, NYHA grade II-IVLeft ventricular ejection fraction (LVEF) ≤ 40% in the past 1 yearClinically confirmed chronic renal insufficiency, eGFR<20ml/min/1.73m2Exclusion Criteria:Allergy to SGLT-2iALT or AST >3 times the upper limit of normal value; Or total bilirubin>2 times the upper limit of normal valueUrinary or reproductive system infection in the last monthBlood potassium is greater than or equal to the upper limit of normal valuePatients with acute heart failurePatients who need intravenous diuretics before randomization, and the dose is greater than 40mg furosemide, or other equivalent intravenous loop diureticsPatients who need intravenous vasodilators, including nitrates, before randomizationSystolic blood pressure<100mmHg was measured during screening or at randomHemoglobin<90g/LUncontrolled serious arrhythmiaThere was myocardial infarction, unstable angina pectoris, hemorrhagic stroke or ischemic stroke in 90 days before randomizationIn 90 days before randomization, patients had proliferative retinopathy or macular disease, painful diabetes neuropathy, diabetes foot, diabetes ketoacidosis, hyperglycemia and hyperosmolality that needed treatmentPatients with malignant tumorsDrug or alcohol addictsPatients who have donated or transfused blood within 90 days before randomization, or are expected to donate or transfuse blood during the study periodPregnant or lactating women, or patients who cannot take reliable contraceptive measures during the study periodPatients with uncontrolled abnormal thyroid functionType 1 diabetesNot suitable evaluated by the researcher