NCT05359263

Effects of Dapagliflozin on EChOcardiographic Measures of CarDiac StructurE and Function in Patients with CKD

A 6-Month, Randomized, Double-Blind Study to Evaluate the Effect of Dapagliflozin on EChOcardiographic Measures of CarDiac StructurE and Function in Patients with Chronic Kidney Disease

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 222 (estimated)
• Sponsor: Tor Biering-Sørensen · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to investigate the effects of dapagliflozin on echocardiographic measures of cardiac structure and function in patients with chronic kidney disease.

Detailed description

The study is a 6-month, investigator-initiated, randomized, double-blind, placebo-controlled clinical trial to evaluate the effects of dapagliflozin on echocardiographic measures of cardiac structure and function in patients with chronic kidney disease. The study population will consist of approximately 222 adults with chronic kidney disease - defined as a glomerular filtration rate (GFR) of 20-60 mL/min/1.73m2, in treatment with maximally tolerated ACEi or ARB. Patients will be randomized to either 10 mg dapagliflozin or placebo. Patients will be assessed by measurement of echocardiography, pulse wave velocity, blood samples, urine samples, quality of life, depressive symptoms, and cognitive function at baseline and after 6 months of treatment.

Conditions

• Chronic Kidney Diseases

Interventions

Type	Name	Description
DRUG	Dapagliflozin 10 mg	The intervention arm consists of dapagliflozin 10 mg orally once daily
DRUG	Placebo	The comparator arm consists of placebo orally once daily

Timeline

• Start date: 2022-06-08
• Primary completion: 2025-02-18
• Completion: 2025-02-18
• First posted: 2022-05-03
• Last updated: 2025-02-10

Locations

1 site across 1 country: Denmark