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

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Participation Requirements

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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 hea...

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 100 patients with decompensated chronic heart failure. The study will be conducted in ?ity clinical hospital number 7, University clinical hospital number 1. Patients will be screened in the first 24-48 hours from the moment of hospitalization, inclusion and exclusion criteria will be applied. The diagnosis of decompensation of chronic heart failure will be made based on the collection of anamnesis, assessment of cardiovascular symptoms and potential risk factors, as well as assessment of symptoms of stagnation or hypoperfusion by physical examination, and confirmed by appropriate additional studies, such as electrocardiogram (ECG) (twelve-channel electrocardiograph MAC 600, ?72244-18), chest X-ray in straight and side projections with radiation load 0,1 mSv (?ombiDiagnost R90, ?2017/6644), laboratory tests (specific biomarkers -N-terminal brain natriuretic propeptide (NT-proBNP) and transthoracic echocardiography (Ge Logic F6; ?9451\61287) on the first day after admission. Intravenous administration of 40 mg of furosemide (lasix; 10 mg / ml; N014865/02) is allowed no later than in the first 24 hours from the moment of admission (provided that the patient has not previously received regular loop diuretics). If prior to this hospitalization, regular therapy with loop diuretics was carried out, the daily dose should be increased by more than 2 times with the transition to intravenous administration. During the first visit, patients who meet the inclusion criteria will be randomized by the random number table method. Participants will be divided into two groups, the main group will include patients receiving dapagliflozin (Forxiga; MP-002596) at a dose of 10 mg / day per os in addition to the current therapy. The comparison group will be patients receiving standard therapy (loop diuretics, vasodilators, digoxin, inotropic agents, vasopressors). During the second visit (on 3-4 days of hospitalization), the researcher will assess the clinical condition (blood pressure, heart rate, respiratory rate, auscultation, edema dynamics), biochemical and general blood analysis, 24-hour diuresis calculation, and patient weighing in both groups of patients. Accounting for how the patient excretes fluid will be made by the research doctor by weighing in the morning on an empty stomach and calculating the volume of diuresis. During the third visit (on the day of discharge ), the researcher will assess the clinical condition (blood pressure, heart rate, respiratory rate, auscultation, edema dynamics), biochemical and general blood analysis, 24-hour diuresis calculation, and patient weighing in both groups of patients. The criterion for acute renal injury will be an increase in serum creatinine by 0.3 mg / dl or more for 48 hours (Kidney Disease: Improving Global Outcomes (KDIGO) criteria). The criteria for refractoriness to diuretic therapy will be the need to increase the daily dose of loop diuretics by more than 2 times compared to the initial one, or the need to add another class of diuretic drugs to the therapy. (Muthiah Vaduganathan et al. Unsolved challenges in diuretic therapy for acute heart failure: a focus on diuretic response.Expert Review of Cardiovascular Therapy/ Volume 13, 2015 -Issue 10. Pages 1075-1078). The initial dose will be the daily dose of loop diuretics used on the first day of hospitalization. In order to find out whether there were repeated hospitalizations or deaths of patients within 30 days, the study participants will be called on the 30th day after discharge. The reliability of the differences in the groups will be determined by the Man-Whitney criterion, the differences will be considered statistically significant at p<0.05. Statistical processing of the obtained data will be carried out using the Statistical Package for the Social Sciences program version 9.0. The study can be classified as a study of average accuracy. The significance level of 0.05 will be used as the limit of the statistical significance of the results, then according to the method of K. A. Otdelnova, the sample size of the dissertation research should be 100 observation units. The research capacity will be 80%.

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