Abstract

Objectives: The aim of the study was to compare the efficacy of combined treatment of chronic heart failure (CHF) patients with mildronate and ACEI (lisinopril) and the treatment with ACEI (lisinopril) used alone. One of the objectives was to assess the influence of both therapies on the reactivity of the carotid baroreceptor reflex.

Design and Methods: The study was designed as a controlled, parallel-group, double-blind, randomised phase IV clinical trial. The study group comprised 57 patients (men and women; aged 30–80 years) with CHF (NYHA I–III) due to coronary heart disease (CHD). The first study 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 (control) group (L20) received L 20 mg daily. The treatment period lasted for 3 months.

Results: Improvement of the main symptoms of CHF, NYHA class, peripheral circulation and contractility of the myocardium in the ML5 and ML20 groups was reported in our previous papers. In CHF patients receiving a prolonged treatment of cardioselective β-adrenergic blockers (metoprolol or bisoprolol), a three-month therapy of mildronate in combination with lisinopril has resulted in an increase of the amplitude of baroreflex bradycardic and hypotensive reactions. The effect was not found to be dependent upon the lisinopril dosage applied in this combination (within the range of the minimal-maximal dose). Besides, neither lisinopril by itself, nor the combination of mildronate with lisinopril were stated to be related with any changes in arterial pressure or the heart rate in CHF patients.

Conclusions: This study has revealed 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 reactivity of the carotid baroreceptor reflex in CHF patients.