Abstract
Aim. To study the effects of complex therapy with the addition of enhanced external counterpulsation (EECP) on exercise tolerance, echocardiographic parameters, markers of glycemic control and clinical outcomes in patients with ischemic chronic heart failure (CHF) with concomitant type 2 diabetes mellitus (DM). Material and methods. Patients with ischemic CHF II-III functional class with type 2 DM were randomized into group 1 (n=20) – optimal medical therapy (OMT) and EECP (35 hours, 2 courses per year), group 2 (n=21) – OMT and EECP (35 hours, 1 course per year), control group (n=20) – OMT and placebo-counterpulsation (35 hours, 1 course per year). The primary endpoint was achieving an HbA1c level of ≤7%. Secondary endpoints included the development of a combined endpoint (CEP: cases of adverse outcomes, hospitalizations for CHF, new onsets of atrial fibrillation, decreased renal function), as well as an increase after 12 months in the distance covered in 6-minue walk test (6MWT) by 20% or more from the baseline. Results. After 12 months, the proportion of patients achieving an HbA1c level of ≤7% in group 1 increased by 30%, in group 2 – by 14.3%, and remained the same in the control group (p=0.005). The proportion of patients with an increase in distance traveled according to 6MWT data >20% after 12 months in the 1st, 2nd and control groups was 100%, 76.2% and 15.0%, respectively (p<0.001). The development of CEP was observed in 3 (15.0%) patients of the 1st group, 7 (33.3%) – of the 2nd group and 12 (60.0%) – of the control group (including 1 case of death), p =0.003. Conclusion. Over a 12-month study period in patients with ischemic heart failure and type 2 diabetes, the addition of EECP to OMT after 12 months demonstrated an improvement in the clinical status of patients, which was accompanied by a decrease in levels of markers of glycemic control and the incidence of adverse outcomes compared with the placebo counterpulsation group.
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