Cardio-microcurrent device treatment for heart failure with reduced ejection fraction:Results from the C-MIC II open-labelrandomized controlled trial

Abstract

Study Aims

In patients with heart failure, alterations in electrical fields generated within the myocardium have been associatedwith myocardial oedema which can act as a substrate for left ventricular dysfunction. Safety and efficacy of a directmicrocurrent 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 inaddition to guideline-directed medical therapy. The primary endpoint was change in LVEF at 6 months. Pre-specifiedsecondary endpoints included 6-min walk distance (6MWD), Kansas City Cardiomyopathy Questionnaire overallsummary score (KCCQ-OSS), and NYHA functional class. Of 70 patients randomized, 65 were included in modifiedintention-to-treat analysis (C-MIC device: n = 32; control: n = 33). At 6 months, treatment with C-MIC versus controlimproved LVEF (mean difference: 5.1%; 95% confidence interval [CI] 3.1–7.1%, p < 0.001). The proportions ofpatients with improvement in at least one NYHA class (risk difference: 68.9%; 95% CI 50.6–87.2, p < 0.001), an ncrease 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 withcontrol improved LVEF, symptoms, functional capacity and quality of life.