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

  • STATUS
    Recruiting
  • days left to enroll
    28
  • participants needed
    100
  • sponsor
    I.M. Sechenov First Moscow State Medical University
Updated on 13 March 2021

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.

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 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%.

Details
Condition Heart failure, Heart disease, Congestive Heart Failure, Cardiac Disease, congestive heart disease
Treatment Standard list of drugs used for acute decompensation of CHF (loop diuretics, vasodilators, digoxin, inotropic agents, vasopressors), plus dapagliflozin (Forxiga; MP-002596)
Clinical Study IdentifierNCT04778787
SponsorI.M. Sechenov First Moscow State Medical University
Last Modified on13 March 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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)
\. Written consent to participate in the study

Exclusion Criteria

A history of type 1 diabetes mellitus, episodes of diabetic ketoacidosis or hypoglycemia that required urgent medical intervention
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
Rhythm of pacemaker more than 20% per day
Therapy with any drug from the sodium-glucose cotransporter type 2 inhibitors (SGLT2i) group, carried out before the screening visit
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
Pregnancy or breastfeeding
Mental illness (if patients are not capable of understanding the nature, significance and implications of the clinical trial)
History of hypersensitivity to any SGLT2 inhibitors
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)
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 )
Glomerular filtration rate (GFR) below 30 ml/min/1.73 m2 (Chronic Kidney Disease Epidemiology Collaboration Formula - CKD-EPI)
Individual intolerance to the components of the drug
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