Clinical trial NCT05737186: SGLT2 Inhibitors and Treatment of Heart Failure in Severe Renal Insufficiency
Official title: The Efficacy and Safety of SGLT2 Inhibitors in Improving Heart Failure in Patients With Chronic Heart Failure With Reduced Ejection Fraction (HFrEF) and Severe Renal Insufficiency
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Heart Failure With Reduced Ejection Fraction
Renal Insufficiency, Chronic
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
First posted: 2023-02-21
Enrollment: 11
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility 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, 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

Primary outcomes:
measure: The quality of Life
timeFrame: 12 weeks
Secondary outcomes:
measure: The quality of Life
timeFrame: 2 weeks, 4weeks and 8weeks
measure: Dose changes of diuretics
timeFrame: 12 weeks
measure: Changes of eGFR
timeFrame: 2 and 12 weeks
measure: Changes of brain natriuretic peptide (BNP)
timeFrame: 12 weeks
measure: Changes of body weight
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University People's Hospital
state: Please Select
Study officials:
References: