Abstract

Objectives: The main aim of the study was to compare the efficacy of combined treatment of chronic heart failure (CHF) with mildronate and angiotensin-converting enzyme inhibitor lisinopril and the treatment of CHF with lisinopril used alone.
Design and Methods: The study was designed as a controlled, parallel-group, double-blind, randomized phase IV clinical trial. The study was carried out in Latvia and Lithuania. The study group comprised 119 patients (men and women; aged 30–80 years) with CHF (NYHA I–III) due to coronary heart disease. The first group (ML20) received mildronate (M) 1000 mg and lisinopril (L) 20 mg daily; the second group (ML5) received M 1000 mg and L 5 mg, the third (L20) received L 20 mg daily.
Results: In the ML20 group, dyspnoea decreased in 48.7% of patients, whereas in the L20 group only in 33.3% of patients. As to the NYHA functional class, the decrease was observed in all groups. During bicycle ergometry, the greatest increase in exercise time was recorded in the ML20 group patients. The changes in parameters of reactive hyperemia in forearm muscles after the treatment were shown to differ greatly in the ML20 and ML5 groups as compared to the L20 group. The analysis of blood flow data of a handgrip test showed statistically significant increase in maximal and summary blood flow in the ML20 group.
Conclusions: This study reveals the advantage of the combined treatment with “lisinopril 20 mg/daily and mildronate 1000 mg/daily” and “lisinopril 5 mg/daily and mildronate 1000 mg/daily” over the treatment with “lisinopril 20 mg/daily” on the leading symptoms of CHF. The combined treatment is associated with the improvement of the quality of life, exercise capacity and mechanisms of peripheral circulation. The additive beneficial effect of mildronate on the vasodilation capacity of the magistral arteries and the resistance vessels at rest and during the static muscle load has been demonstrated.