| Trial ID: | L2664 |
| Source ID: | NCT06442280
|
| Associated Drug: |
Dapagliflozin Tablet
|
| Title: |
SGLT-2 Inhibitor and High-Dose Furosemide Plus Small-Volume Hypertonic Saline Solution in Acute HF
|
| Acronym: |
DAPA-TONIC
|
| Status: |
NOT_YET_RECRUITING
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Heart Failure Acute|Diabetes Type 2|Heart Failure With Reduced Ejection Fraction|Heart Failure With Preserved Ejection Fraction
|
| Interventions: |
DRUG: Dapagliflozin tablet|DRUG: Hypertonic Saline Solution, 1 Ml|DRUG: Furosemide Injection
|
| Outcome Measures: |
Primary: Diuresis from the baseline and up to 1 week, Daily urinary volume (mL) are detected by chemiluminescence immunoassay., an average of 1 week|Natriuresis from the baseline and up to 1 week, Daily natriuresis (mEq/L) are detected by chemiluminescence immunoassay., an average of 1 week|Length of hospital stay, Duration of hospital stay in days., immediately after the intervention | Secondary: Kidney function during treatment, Daily evaluation of creatinine (mg/dL)., an average of 1 week
|
| Sponsor/Collaborators: |
Sponsor: University of Palermo
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
544
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
|
| Start Date: |
2024-06
|
| Completion Date: |
2026-03-30
|
| Results First Posted: |
|
| Last Update Posted: |
2024-06-06
|
| Locations: |
|
| URL: |
https://clinicaltrials.gov/show/NCT06442280
|
