SGLT2 Inhibitors and Treatment of Heart Failure in Severe Renal Insufficiency

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

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).

Study Overview

• Status: Terminated
• Conditions: Renal Insufficiency, Chronic; Heart Failure With Reduced Ejection Fraction
• Intervention / Treatment: Drug: SGLT-2 inhibitor

• Study Type: Interventional
• Enrollment (Actual): 11
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Please Select
    • Beijing, Please Select, China, 100044
      • Peking University People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group
Experimental: Intervention group	Drug: SGLT-2 inhibitor; dapagliflozin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The quality of Life	The change of Quality of Life in patients by using the The Kansas City Cardiomyopathy Questionnaire(KCCQ)	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The quality of Life	The change of Quality of Life in patients by using the KCCQ	2 weeks, 4weeks and 8weeks
Dose changes of diuretics	Dose changes of diuretics in subgroups of patients without dialysis	12 weeks
Changes of body weight	Changes of Body weight and BMI	12 weeks
Changes of eGFR	Changes of eGFR in the subgroup of non-dialysis patients at 2 and 12 weeks	2 and 12 weeks
Changes of brain natriuretic peptide (BNP)	Changes of BNP	12 weeks

Collaborators and Investigators

• Sponsor: Peking University People's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 9, 2023
• Primary Completion (Actual): April 16, 2024
• Study Completion (Actual): April 16, 2024

Study Registration Dates

• First Submitted: February 12, 2023
• First Submitted That Met QC Criteria: February 12, 2023
• First Posted (Actual): February 21, 2023

Study Record Updates

• Last Update Posted (Actual): April 30, 2024
• Last Update Submitted That Met QC Criteria: April 27, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Kidney Diseases; Urologic Diseases; Disease Attributes; Chronic Disease; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Heart Failure; Renal Insufficiency, Chronic; Renal Insufficiency; Hypoglycemic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Sodium-Glucose Transporter 2 Inhibitors
• Other Study ID Numbers: DAPA-FF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No