SGLT2 Inhibitors and Treatment of Heart Failure in Severe Renal Insufficiency

• Status: Not yet recruiting
• Trial end date: 2024-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Peking University People's Hospital
• Treatments: Sodium-Glucose Transporter 2 Inhibitors

Criteria

Inclusion Criteria:

• Age 20-75 years

• Patients 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-IV

• Left ventricular ejection fraction (LVEF) ≤ 40% in the past 1 year

• Clinically confirmed chronic renal insufficiency, eGFR<20ml/min/1.73m2

Exclusion Criteria:

• Allergy to SGLT-2i

• ALT or AST >3 times the upper limit of normal value; Or total bilirubin>2 times the upper limit of normal value

• Urinary or reproductive system infection in the last month

• Blood potassium is greater than or equal to the upper limit of normal value

• Patients with acute heart failure

• Patients who need intravenous diuretics before randomization, and the dose is greater than 40mg furosemide, or other equivalent intravenous loop diuretics

• Patients who need intravenous vasodilators, including nitrates, before randomization

• Systolic blood pressure<100mmHg was measured during screening or at random

• Hemoglobin<90g/L

• Uncontrolled serious arrhythmia

• There was myocardial infarction, unstable angina pectoris, hemorrhagic stroke or ischemic stroke in 90 days before randomization

• In 90 days before randomization, patients had proliferative retinopathy or macular disease, painful diabetes neuropathy, diabetes foot, diabetes ketoacidosis, hyperglycemia and hyperosmolality that needed treatment

• Patients with malignant tumors

• Drug or alcohol addicts

• Patients who have donated or transfused blood within 90 days before randomization, or are expected to donate or transfuse blood during the study period

• Pregnant or lactating women, or patients who cannot take reliable contraceptive measures during the study period

• Patients with uncontrolled abnormal thyroid function

• Type 1 diabetes

• Not suitable evaluated by the researcher