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 Changes of brain natriuretic peptide (BNP) 12 weeks Changes of BNP
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 body weight 12 weeks Changes of Body weight and BMI
Trial Locations
- Locations (1)
Peking University People's Hospital
🇨🇳Beijing, Please Select, China