SGLT2 Inhibitors and Treatment of Heart Failure in Severe Renal Insufficiency
- Conditions
- Heart Failure With Reduced Ejection FractionRenal Insufficiency, Chronic
- Interventions
- Drug: SGLT-2 inhibitor
- Registration Number
- NCT05737186
- Lead Sponsor
- Peking University People's Hospital
- Brief 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 chronic kidney disease (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 SGLT-2i can improve the outcome of HF in patients with chronic heart failure with reduced ejection fraction (HFrEF) and severe chronic renal insufficiency (eGFR\<20ml/min/1.73m2).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 11
- 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, New York Heart Association (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 or maintenance hemodialysis
- 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 measured during screening or at randomization
- Hemoglobin<90g/L
- Uncontrolled serious arrhythmia
- Myocardial infarction, unstable angina pectoris, hemorrhagic stroke or ischemic stroke in 90 days before randomization
- Proliferative retinopathy or macular disease, painful diabetes neuropathy, diabetes foot, diabetes ketoacidosis, hyperglycemic hyperosmolality that needed treatment in 90 days before randomization
- 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 investigator
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention group SGLT-2 inhibitor -
- Primary Outcome Measures
Name Time Method The quality of Life 12 weeks The change of Quality of Life in patients by using the The Kansas City Cardiomyopathy Questionnaire(KCCQ)
- Secondary Outcome Measures
Name Time Method Dose changes of diuretics 12 weeks Dose changes of diuretics in subgroups of patients without dialysis
The quality of Life 2 weeks, 4weeks and 8weeks The change of Quality of Life in patients by using the KCCQ
Changes of eGFR 2 and 12 weeks Changes of eGFR in the subgroup of non-dialysis patients at 2 and 12 weeks
Changes of brain natriuretic peptide (BNP) 12 weeks Changes of BNP
Changes of body weight 12 weeks Changes of Body weight and BMI
Trial Locations
- Locations (1)
Peking University People's Hospital
🇨🇳Beijing, Please Select, China
Peking University People's Hospital🇨🇳Beijing, Please Select, China