Results of the C-MIC II trial have been published in the European Journal of Heart Failure, following their presentation as a late-breaking clinical trial (LBCT) at the 2025 ESC-HFA Congress (17–20 May, Belgrade, Serbia).
The findings highlight the potential of the Cardio-Microcurrent (C-MIC) device—a novel implantable system that delivers low-intensity microcurrent to the failing myocardium—in heart failure treatment, Berlin Heals, the manufacturer of the device says in a press release.
In this open-label, randomised controlled trial, 70 ambulatory patients with non-ischaemic dilated cardiomyopathy, left ventricular ejection faction (LVEF) 25–35%, and New York Heart Association (NYHA) class III–IV symptoms were randomised 1:1 to receive C-MIC therapy plus guideline-directed medical therapy (GDMT) or GDMT alone.
The primary endpoint was the difference in change in LVEF at six months. Secondary endpoints included change in NYHA class, six-minute walk distance (6MWD), and Kansas City Cardiomyopathy Questionnaire overall summary score (KCCQ-OSS).
At six months, patients receiving C-MIC therapy experienced markedly greater improvements than controls across all prespecified endpoints. LVEF rose by an average of 6.6% in the C-MIC group versus 1.5% in the control group, yielding a mean between-group difference of 5.1% (95% confidence interval [CI] 3.1–7.1; p<0.001).
Clinically meaningful functional gains were similarly superior: 84% of C-MIC patients improved by at least one NYHA class compared with 15% of controls—a risk difference of 68.9% (95% CI 50.6–87.2; p< 0.001).
Quality-of-life also benefited, with 75% of C-MIC patients achieving a ≥5-point increase in KCCQ-OSS versus 15% in controls (risk difference 60%, 95% CI 42.3–77.6; p<0.001). Finally, nearly half of treated patients (47%) attained at least a 30% rise in six-minute-walk distance compared with only 9% of controls (risk difference 38.3%, 95% CI 14.4–62.2; p=0.002), underscoring consistent benefit across structural, symptomatic, and functional outcomes. The therapy was well tolerated, with no device-related serious adverse events reported.
“This study offers compelling evidence that microcurrent therapy can enhance both cardiac function and patient-centred outcomes in individuals with HFrEF,” said Jesus E Rame (Thomas Jefferson University, Philadelphia, USA), the study’s co-first author. “These findings introduce a promising new therapeutic avenue for patients who remain symptomatic despite receiving optimal medical therapy. This randomised controlled trial not only demonstrates the efficacy and safety of the therapy in patients with stable, chronic ambulatory heart failure, but also pioneers an entirely novel treatment paradigm aimed at restoring cardiac function in non-ischaemic cardiomyopathy.”
Stefan D Anker (Charité Universitätsmedizin, Berlin, Germany), senior author, added: “This is the first randomised trial to demonstrate that low-level microcurrent stimulation can improve both structural heart function and quality of life. It establishes a strong foundation for future studies focused on long-term clinical outcomes.”
“We are thrilled to see the C-MIC II results published in the European Journal of Heart Failure,” said John Brumfield, chief executive officer of Berlin Heals. “These findings support our mission to develop breakthrough, bioelectronic therapies for chronic heart failure—targeting the disease at its electrical and cellular roots.”
