Sodium-glucose Cotransporter Type 2 Inhibitors for Acute Cardiorenal Syndrome Prevention
- Sponsor
- I.M. Sechenov First Moscow State Medical University
- Study ID
- NCT04778787
- Phase
- PHASE4
- Status
- Completed
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Standard list of drugs used for acute decompensation of CHF (loop diuretics, vasodilators, digoxin, inotropic agents, vasopressors), plus dapagliflozin (Forxiga; MP-002596) — DRUGPatients will receive dapagliflozin at a dose of 10 mg daily during hospitalization in addition to ongoing therapy
Study Details
The effect of sodium-glucose cotransporter type 2 inhibitors (SGLT2i) on the parameters of renal function in acute decompensation of chronic heart failure (ADHF) compared to standard therapy will be analyzed. Based on the dynamics of the clinical condition, the duration of hospitalization, and blood biochemical parameters (creatinine, urea, uric acid, potassium, sodium, N-terminal pro-brain natriuretic peptide - NT-proBNP) conclusions will be drawn about the possibility of using SGLT2i in this group of patients.
Key Dates
- Start date
- Jan 1, 2021
- Status verified
- Mar 2022
- Primary completion
- Aug 1, 2022
- Completion
- Aug 1, 2022
Study Design
- Enrollment
- 370 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: the intervention groupThe intervention group includes patients with decompensated chronic heart failure. The diagnosis will be made according to the criteria described above
- Experimental: the control groupThe control group will be identical to the main group.
Primary Outcome Measure
death due to heart failure [ Time Frame: through study completion, an average of 5 days ]
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