Status:
COMPLETED
Sodium-glucose Cotransporter Type 2 Inhibitors for Acute Cardiorenal Syndrome Prevention
Lead Sponsor:
I.M. Sechenov First Moscow State Medical University
Conditions:
Congestive Heart Failure
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 a...
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...
Eligibility Criteria
Inclusion
- Inclusion criteria
- 1\. Diagnosed ADHF (based on 1) presence of congestion (based on the presence of dyspnoea and at least two of the following:congestion on chest X-ray, 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) 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)) 2. The need for intravenous administration of loop diuretics on admission 3. Age over 18 years Patients were included after signing an informed consent Exclusion criteria
- Cardiogenic shock (systolic blood pressure \<90 mm Hg; signs of hypoperfusion (altered mental status, cold skin, diuresis \<30 ml / hour, blood lactate level \>2.0 mmol / l).
- Urinary tract infection
- Type 1 diabetes mellitus (DM1), episodes of diabetic ketoacidosis or hypoglycemia
- Prior use of drugs from the SGLT2i group, taken regularly within 4 weeks
- GFR\<30 ml / min / 1.73 m2 (CKD-EPI).
- Individual SGLT2i intolerance
- Child-Pugh class C liver failure
- Mental illness (inability to sign an informed consent, lack of understanding of possible consequences)
- Pregnancy or breastfeeding
- Refusal to sign an informed consent
Exclusion
Key Trial Info
Start Date :
January 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2022
Estimated Enrollment :
370 Patients enrolled
Trial Details
Trial ID
NCT04778787
Start Date
January 1 2021
End Date
August 1 2022
Last Update
December 7 2022
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
University Clinical Hospital number 1
Moscow, Russia
2
Сity Сlinical Нospital number 7
Moscow, Russia