Sodium-glucose Cotransporter Type 2 Inhibitors for Acute Cardiorenal Syndrome Prevention

• Status: Recruiting
• Trial end date: 2022-01-01
• Target enrollment: 0
• Participant gender: All

Summary

The effect of sodium-glucose cotransporter type 2 inhibitors (SGLT2i) on the parameters of renal function in acute decompensation of chronic heart failure (CHF) 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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: I.M. Sechenov First Moscow State Medical University
• Treatments: 2-(3-(4-ethoxybenzyl)-4-chlorophenyl)-6-hydroxymethyltetrahydro-2H-pyran-3,4,5-triol; Dapagliflozin; Digoxin; Diuretics; Sodium Potassium Chloride Symporter Inhibitors; Vasoconstrictor Agents; Vasodilator Agents

Criteria

Inclusion Criteria:

1. Clinically diagnosed acute decompensation of chronic heart failure. The diagnosis will be made based on the collection of anamnesis and potential risk factors (hypertension, previous myocardial infarction, myocarditis, cardiomyopathies, cardiotoxic drugs), assessment of cardiovascular symptoms (dyspnea, orthopnea, paroxysmal nocturnal dyspnea, decreased exercise tolerance, weakness, fatigue, weight gain of more than 2 kilograms per week, third tone (gallop rhythm), hepatomegaly, ascites), and the need for intravenous administration of loop diuretics on the first day of hospitalization. The diagnosis will be confirmed by appropriate additional studies, such as ECG (scarring of the myocardium, blockage of the right or left legs of the bundle of Gis, signs of myocardial hypertrophy), chest x-ray (the identification of cardiomegaly, effusion in the sinuses, pulmonary edema), laboratory

tests (specific biomarkers - NT-proBNP more than 400 pg / ml) and echocardiography (evaluation of systolic and diastolic function)

2. Written consent to participate in the study

Exclusion Criteria:

1. A history of type 1 diabetes mellitus, episodes of diabetic ketoacidosis or hypoglycemia that required urgent medical intervention

2. Significant valvular defects (aortic regurgitation of the 3rd degree, aortic stenosis with a valve opening area of less than 1 cm2), except for mitral and tricuspid regurgitation

3. Rhythm of pacemaker more than 20% per day

4. Therapy with any drug from the sodium-glucose cotransporter type 2 inhibitors (SGLT2i) group, carried out before the screening visit

5. Potentially reversible causes of heart failure, such as inflammatory myocardial diseases, heart defects (congenital and acquired), pericarditis (constrictive and exudative), cardiac arrhythmias (brady - and tachyarrhythmias), arterial hypertension, myxoma of the heart, anemia, hyper - and hypothyroidism, ischemic heart disease (in the case of angioplasty, coronary artery bypass grafting, aneurysmectomy), myocardial insufficiency as a component of multiple organ failure in decompensation of liver and kidney diseases, as well as peripartal cardiomyopathy.

6. Pregnancy or breastfeeding

7. Mental illness (if patients are not capable of understanding the nature, significance and implications of the clinical trial)

8. History of hypersensitivity to any SGLT2 inhibitors

9. Cardiogenic shock (decrease in systolic pressure <90 mmHg for more than 30 minutes, average blood pressure less than 65 mmHg for more than 30 minutes, or the need for vasopressors to maintain systolic pressure ≥90 mmHg; signs of stagnation in the lungs or increased left ventricular filling pressure; signs of organ hypoperfusion)

10. The presence of an acute infectious process, including the urinary tract (fever, leukocytosis with a shift leukocyte formula to the left, increased erythrocyte sedimentation rate (ESR), increased C-reactive protein blood, leukocyturia )

11. Glomerular filtration rate (GFR) below 30 ml/min/1.73 m2 (Chronic Kidney Disease Epidemiology Collaboration Formula - CKD-EPI)

12. Individual intolerance to the components of the drug