| Trial ID: | L1507 |
| Source ID: | NCT05179668
|
| Associated Drug: |
Dapagliflozin 10 Mg
|
| Title: |
SGLT2 Inhibition in Hemodialysis
|
| Acronym: |
DAPA-HD
|
| Status: |
RECRUITING
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Kidney Failure|Hemodialysis|Diabetes Mellitus, Type 2|Chronic Kidney Disease|Left Ventricular Hypertrophy
|
| Interventions: |
DRUG: Dapagliflozin 10 MG|DRUG: Placebo
|
| Outcome Measures: |
Primary: Δ Left ventricular mass indexed to body surface area, measured by cMRI, From baseline to 6 months | Secondary: Δ HbA1c [%], Change in relative %, From baseline to 6 months|Δ Left ventricular mass indexed to body height, measured by cMRI, From baseline to 6 months|Δ Left ventricular ejection fraction, measured by cMRI, From baseline to 6 months|Δ Cardiac fibrosis, measured by cMRI, From baseline to 6 months|Δ Body weight [kg], Change in kg, From baseline to 6 months
|
| Sponsor/Collaborators: |
Sponsor: Medical University of Vienna | Collaborators: Vienna Dialysis Center
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
108
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2022-10-01
|
| Completion Date: |
2025-09-30
|
| Results First Posted: |
|
| Last Update Posted: |
2022-10-25
|
| Locations: |
Medical University of Vienna, Vienna, 1090, Austria
|
| URL: |
https://clinicaltrials.gov/show/NCT05179668
|
