Effect of sodium-glucose cotransporter type 2 inhibitors on the course of heart failure in patients with amyloid cardiomyopathy: Results of a pilot single-center randomized trial

Aim. To evaluate the efficacy and safety of the use of sodium-glucose cotransporter type 2 (SGLT-2) inhibitors in patients with chronic heart failure (CHF) due to amyloid cardiomyopathy (ACM). Materials and methods. 50 patients with CHF due to different types of ACM were included and randomized in two groups at a ratio of 1:1. In the 1st group (n=25), SGLT-2 inhibitors were added to basic therapy. In the 2nd group (n=25) patients received only basic therapy. The observation period was 6 months. Clinical function status, laboratory marker dynamics, echocardiography parameters, frequency of hospitalizations and presence of cardiovascular events were evaluated. Results. SGLT-2 inhibitors therapy was well tolerated, safe. The frequency of hospitalizations due to decompensated heart failure was higher in the 2nd group (p=0.048), cases of hospitalization in the 2nd group occurred statistically significantly earlier (p=0.017). Mortality in the 1st group was 4% (1 case), in the 2nd group – 16% (4 cases), due to progressive CHF. In the 1st group, the distance of a 6-minute walk test increased (p0.001), the quality of life assessed by the Minnesota Living with Heart Failure Questionnaire improved (p0.001), the expression of shortness decreased (p0.001), there was an improvement in clinical status according to the clinical assessment scale (p0.001), while in the 2nd group there was a statistically significant deterioration of clinical functional status. The dynamics of the N-terminal pro-Brain Natriuretic Peptide and troponine levels were positive in the 1st group and negative in the 2nd group (p=0.001 and 0.001 respectively). Significant changes in the glomerular filtration rate in the 1st group were not detected (p=0.475), in the 2nd group there was a decrease of this parameter (p0.001). According to the results of echocardiography in the 2nd group a significant reduction of the left ventricular (LV) ejection fraction (p=0.001) was observed, and in the 1st group was a tendency to decrease of the LV ejection fraction (p=0.238). Regardless of the SGLT-2 inhibitors intake, there was a decrease in the end-diastolic dimension of LV (p=0.046 for 1st group and 0.001 – for 2nd group), as well as a progressive thickening of heart walls (p=0.011 and 0.001 for interventricular septum thickness, p=0.004 and 0.001 – for posterior wall thickness of LV). Conclusion. The administration of SGLT-2 inhibitors to patients with CHF due to ACM leads to an improvement in quality of life, a decrease in the frequency of hospitalizations due to decompensated heart failure of CHF, but does not affect mortality. Further study of therapeutic efficacy in more patients is needed.