About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Signed informed consent
≥ 18 years of age
Chronic kidney disease (CKD), defined as evidence of decreased eGFR (eGFR ≥20 and <60 mL/minute per 1.73 m2) or between eGFR ≥60 and <90 mL/minute per 1.73 m2 with urinary albumin:creatinine ratio ≥200 mg/g or protein:creatinine ratio ≥300 mg/g
Stable treatment with clinically appropriate doses of ACEi/ARB among CKD patients with proteinuria and uptitrated to maximal recommended or tolerated dose for at least 4 weeks before randomization, if not medically contraindicated
Disqualifiers
Type 1 diabetes
Patients undergoing dialysis
History of organ transplant
Treatment with SGLT2 inhibitor within 8 weeks prior to enrolment
Trial design
Parallel
Treatments tested in this trial
Dapagliflozin 10 mg
DrugThe intervention arm consists of dapagliflozin 10 mg orally once daily
Placebo
DrugThe comparator arm consists of placebo orally once daily
Treatment groups
Trial outcomes
Primary outcomes
Change in LV mass index assessed by echocardiography at 6 months
Secondary outcomes
Change in LVEF assessed by echocardiography at 6 months
Change in LA volume index assessed by echocardiography at 6 months
Change in GLS assessed by echocardiography at 6 months
Change in high sensitivity troponin I (hs-TNI) at 6 months
Sponsors and contacts
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Tor Biering-Sørensen
Lead sponsor
Herlev and Gentofte Hospital
Sponsor institution