| Trial ID: | L0059 |
| Source ID: | NCT05359263
|
| Associated Drug: |
Dapagliflozin 10 Mg
|
| Title: |
Effects of Dapagliflozin on EChOcardiographic Measures of CarDiac StructurE and Function in Patients with CKD
|
| Acronym: |
DECODE-CKD
|
| Status: |
RECRUITING
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Chronic Kidney Diseases
|
| Interventions: |
DRUG: Dapagliflozin 10 mg|DRUG: Placebo
|
| Outcome Measures: |
Primary: Change in LV mass index assessed by echocardiography at 6 months, 6 months | Secondary: Change in LVEF assessed by echocardiography at 6 months, 6 months|Change in LA volume index assessed by echocardiography at 6 months, 6 months|Change in GLS assessed by echocardiography at 6 months, 6 months|Change in high sensitivity troponin I (hs-TNI) at 6 months, 6 months|Change in N-terminal pro B-type natriuretic peptide (NT-pro-BNP) at 6 months, 6 months|Change in estimated glomerular filtration rate (eGFR) 6 months, 6 months|Change in urinary albumin-to-creatinine ratio (UACR) at 6 months, 6 months|Change in hemoglobin at 6 months, 6 months|Change in LV mass assessed by echocardiography at 6 months, 6 months|Change in LV end-diastolic volume at 6 months, 6 months|Change in LV end-systolic volume at 6 months, 6 months
|
| Sponsor/Collaborators: |
Sponsor: Tor Biering-Sørensen
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
222
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2022-06-08
|
| Completion Date: |
2025-02-18
|
| Results First Posted: |
|
| Last Update Posted: |
2025-02-10
|
| Locations: |
Gentofte Hospital, Copenhagen, 2900, Denmark
|
| URL: |
https://clinicaltrials.gov/show/NCT05359263
|
