SGLT2 Inhibitors and Treatment of Heart Failure in Severe Renal Insufficiency

NCT ID: NCT05737186

Last Updated: 2024-04-30

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-09
• Study Completion Date: 2024-04-16

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).

Conditions

Heart Failure With Reduced Ejection Fraction; Renal Insufficiency, Chronic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Intervention group

Group Type: EXPERIMENTAL

SGLT-2 inhibitor

Intervention Type: DRUG

dapagliflozin

Control group

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

SGLT-2 inhibitor

dapagliflozin

Intervention Type: DRUG

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peking University People's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Ren qian

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Peking University People's Hospital

Beijing, Please Select, China

Countries

China

Other Identifiers

DAPA-FF

Identifier Type: -

Identifier Source: org_study_id