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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorTor Biering-Sørensen

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Dapagliflozin 10 mg

    Drug

    The intervention arm consists of dapagliflozin 10 mg orally once daily

  • Placebo

    Drug

    The comparator arm consists of placebo orally once daily

Treatment groups

222 Participants
are divided into 2 treatment groups
Group A: Dapagliflozin 10 mg once dailyExperimental treatment 1 intervention
Group B: Placebo once dailyPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in LV mass index assessed by echocardiography at 6 months

Time frame
6 months

Secondary outcomes

1

Change in LVEF assessed by echocardiography at 6 months

Time frame
6 months
2

Change in LA volume index assessed by echocardiography at 6 months

Time frame
6 months
3

Change in GLS assessed by echocardiography at 6 months

Time frame
6 months
4

Change in high sensitivity troponin I (hs-TNI) at 6 months

Time frame
6 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Tor Biering-Sørensen

Lead sponsor

Herlev and Gentofte Hospital

Sponsor institution