SGLT2 Inhibitors and Treatment of Heart Failure in Severe Renal Insufficiency

Renal Insufficiency, Chronic Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05737186
• Other study ID #: DAPA-FF
• Status: Terminated
• Phase: Phase 4
• Start date: March 9, 2023
• Est. completion date: April 16, 2024

Study information

• Verified date: April 2024
• Source: Peking University People's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 11
• Est. completion date: April 16, 2024
• Est. primary completion date: April 16, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure With Reduced Ejection Fraction
• Renal Insufficiency
• Renal Insufficiency, Chronic

Intervention

Drug:
• SGLT-2 inhibitor
dapagliflozin

Locations

Country	Name	City	State
China	Peking University People's Hospital	Beijing	Please Select

Sponsors (1)

Lead Sponsor	Collaborator
Peking University People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The quality of Life	The change of Quality of Life in patients by using the The Kansas City Cardiomyopathy Questionnaire(KCCQ)	12 weeks
Secondary	The quality of Life	The change of Quality of Life in patients by using the KCCQ	2 weeks, 4weeks and 8weeks
Secondary	Dose changes of diuretics	Dose changes of diuretics in subgroups of patients without dialysis	12 weeks
Secondary	Changes of eGFR	Changes of eGFR in the subgroup of non-dialysis patients at 2 and 12 weeks	2 and 12 weeks
Secondary	Changes of brain natriuretic peptide (BNP)	Changes of BNP	12 weeks
Secondary	Changes of body weight	Changes of Body weight and BMI	12 weeks