Cardio-Microcurrent Device Treatment for Heart Failure with Reduced Ejection Fraction: Results from the C-MIC II Open-Label Randomized Controlled Trial

AIMS: In patients with heart failure, alterations in electrical fields generated within the myocardium have been associated with myocardial oedema which can act as a substrate for left ventricular dysfunction. Safety and efficacy of a direct microcurrent therapy using an implanted generator (C-MIC) remain uncertain. METHODS AND RESULTS: Ambulatory patients with non-ischaemic dilated cardiomyopathy with left ventricular ejection fraction (LVEF) of 25% to 35% and New York Heart Association (NYHA) class III-IV were randomized to C-MIC (device) or control group in addition to guideline-directed medical therapy. The primary endpoint was change in LVEF at 6 months. Pre-specified secondary endpoints included 6-min walk distance (6MWD), Kansas City Cardiomyopathy Questionnaire overall summary score (KCCQ-OSS), and NYHA functional class. Of 70 patients randomized, 65 were included in modified intention-to-treat analysis (C-MIC device: n = 32; control: n = 33). At 6 months, treatment with C-MIC versus control improved LVEF (mean difference: 5.1%; 95% confidence interval [CI] 3.1-7.1%, p < 0.001). The proportions of patients with improvement in at least one NYHA class (risk difference: 68.9%; 95% CI 50.6-87.2, p < 0.001), an increase of ≥5 points in KCCQ-OSS (risk difference: 60.0%; 95% CI 42.3-77.6, p < 0.001), and an increase of ≥30% in 6MWD (risk difference: 38.3%; 95% CI 14.4-62.2) were substantially higher in the device versus control group (p < 0.002). CONCLUSIONS: In patients with non-ischaemic chronic heart failure with reduced ejection fraction, the C-MIC device compared with control improved LVEF, symptoms, functional capacity and quality of life.