Heart Failure With Reduced Ejection Fraction, Renal Insufficiency, Chronic
Conditions
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).
Interventions
DRUGSGLT-2 inhibitor
dapagliflozin
Sponsors
Peking University People's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
No
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, 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
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 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The quality of Life | 12 weeks | The change of Quality of Life in patients by using the The Kansas City Cardiomyopathy Questionnaire(KCCQ) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The quality of Life | 2 weeks, 4weeks and 8weeks | The change of Quality of Life in patients by using the KCCQ |
| Dose changes of diuretics | 12 weeks | Dose changes of diuretics in subgroups of patients without dialysis |
| 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 |
Countries
China
Outcome results
None listed