SGLT2 Inhibitors and Treatment of Heart Failure in Severe Renal Insufficiency

Peking University

Status and phase

Terminated

Phase 4

Conditions

Heart Failure With Reduced Ejection Fraction

Renal Insufficiency, Chronic

Treatments

Drug: SGLT-2 inhibitor

Study type

Interventional

Funder types

Other

Identifiers

NCT05737186

DAPA-FF

Details and patient eligibility

About

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).

Enrollment

11 patients

Sex

All

Ages

20 to 75 years old

Volunteers

No Healthy Volunteers

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