SGLT2 Inhibitors and Treatment of Heart Failure in Severe Renal Insufficiency

NCT05737186 | Terminated Phase 4

• 1 other identifier: DAPA-FF
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• The quality of Life

  The change of Quality of Life in patients by using the The Kansas City Cardiomyopathy Questionnaire(KCCQ)

  12 weeks

Secondary Outcomes (5)

• The quality of Life

  2 weeks, 4weeks and 8weeks

• Dose changes of diuretics

  12 weeks

• Changes of eGFR

  2 and 12 weeks

• Changes of brain natriuretic peptide (BNP)

  12 weeks

• Changes of body weight

  12 weeks

Study Arms (2)

Intervention group

EXPERIMENTAL

Drug: SGLT-2 inhibitor

Control group

NO INTERVENTION

Interventions

SGLT-2 inhibitor DRUG

dapagliflozin

Intervention group

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Peking University People's Hospital: lead

Study Sites (1)

Peking University People's Hospital

Beijing, Please Select, 100044, China

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

Sodium-Glucose Transporter 2 Inhibitors

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Hypoglycemic Agents; Physiological Effects of Drugs

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 12, 2023
• First Posted: February 21, 2023
• Study Start: March 9, 2023
• Primary Completion: April 16, 2024
• Study Completion: April 16, 2024
• Last Updated: April 30, 2024

Record last verified: 2024-04

Locations

CN (1)