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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
222
The intervention arm consists of dapagliflozin 10 mg orally once daily
The comparator arm consists of placebo orally once daily
Gentofte Hospital
Copenhagen, Denmark
RECRUITINGChange in LV mass index assessed by echocardiography at 6 months
Time frame: 6 months
Change in LVEF assessed by echocardiography at 6 months
Time frame: 6 months
Change in LA volume index assessed by echocardiography at 6 months
Time frame: 6 months
Change in GLS assessed by echocardiography at 6 months
Time frame: 6 months
Change in high sensitivity troponin I (hs-TNI) at 6 months
Time frame: 6 months
Change in N-terminal pro B-type natriuretic peptide (NT-pro-BNP) at 6 months
Time frame: 6 months
Change in estimated glomerular filtration rate (eGFR) 6 months
Time frame: 6 months
Change in urinary albumin-to-creatinine ratio (UACR) at 6 months
Time frame: 6 months
Change in hemoglobin at 6 months
Time frame: 6 months
Change in LV mass assessed by echocardiography at 6 months
Time frame: 6 months
Change in LV end-diastolic volume at 6 months
Time frame: 6 months
Change in LV end-systolic volume at 6 months
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Time frame: 6 months