Impact of Sodium-glucose Cotransporter Type 2 Inhibitors on the Course of Cardiorenal Syndrome in Acute Decompensation of Chronic Heart Failure
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Enrollment
- 370
- Locations
- 2
- Primary Endpoint
- death due to heart failure
Study Overview
Brief Summary
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.
Detailed Description
This is a randomized multicenter prospective clinical trial involving patients over 18 years of age who were hospitalized due to decompensation of chronic heart failure (CHF).
The aim of the study is to evaluate the effect of SGLT2i on renal function in the treatment of decompensation of chronic heart failure compared to standard therapy.
The study is planned to include 370 patients with decompensated chronic heart failure. The study will be conducted in Сity clinical hospital number 7, University clinical hospital number 1.
Patients will be screened in the first 24 hours from the moment of hospitalization, inclusion and exclusion criteria will be applied. The ADHF diagnosis was made based on 1) presence of congestion (based on the presence of dyspnoea and at least two of the following:congestion on chest X-ray in straight and side projections with radiation load 0,1 mSv (СombiDiagnost R90, №2017/6644), rales on chest auscultation, peripheral edema, swelling of the cervical veins, hepatomegaly, ascites, hepatojugular reflux) 2) the need for intravenous administration of loop diuretics.
The diagnosis will be confirmed by echocardiography (ECHO) (Ge Logic F6; №9451\61287) to assess systolic (a decrease in LV ejection fraction (LVEF) <50%) and diastolic dysfunction (ratio of early diastolic transmitral E flow to the average early diastolic velocity of the fibrous ring e´ >14; left atrial volume index (LAVI) >34 ml/m2; the maximum speed of tricuspid regurgitation >2.8 m/s ( American Society of Echocardiography (ASE)/European Association of Cardiovascular Imaging (EACVI) recommendations)[11]) and the presence of an enlarged, non-collapsing on inspiration inferior vena cava (IVC).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
the intervention group
The intervention group includes patients with decompensated chronic heart failure. The diagnosis will be made according to the criteria described above
Intervention: Standard list of drugs used for acute decompensation of CHF (loop diuretics, vasodilators, digoxin, inotropic agents, vasopressors), plus dapagliflozin (Forxiga; MP-002596) (Drug)
the control group
The control group will be identical to the main group.
Intervention: Standard list of drugs used for acute decompensation of CHF (loop diuretics, vasodilators, digoxin, inotropic agents, vasopressors), plus dapagliflozin (Forxiga; MP-002596) (Drug)
Outcomes
Primary Outcomes
death due to heart failure
Time Frame: through study completion, an average of 5 days
Death during hospitalization
Secondary Outcomes
- deterioration of renal function (increase in blood creatinine by 0.3 mg / dl within 48 hours)(through study completion, an average of 5 days)
- development of resistance to diuretics(through study completion, an average of 5 days)
- re-hospitalization about decompensation of chronic heart failure within 30 days after discharge from the hospital(up to 30 days)