Groundbreaking Microcurrent Therapy Trial Shows Promise for Heart Failure Patients

Groundbreaking Trial Unveils Efficacy of Microcurrent Therapy in Heart Failure

In a remarkable culmination of research, the C-MIC II clinical trial has demonstrated the efficacy of microcurrent therapy in patients suffering from heart failure. The study's results were published in the esteemed European Journal of Heart Failure and shed light on the novel Cardio-Microcurrent (C-MIC) device, which has shown substantial promise in improving cardiac function among individuals with reduced ejection fraction heart failure.

The study, which was prominently presented as a Late-Breaking Clinical Trial at the 2025 ESC HFA Congress in Belgrade, involved 70 patients diagnosed with non-ischemic dilated cardiomyopathy displaying moderate to severe symptoms. The clinical trial was designed as an open-label, randomized controlled trial, comparing participants receiving C-MIC therapy alongside guideline-directed medical therapy (GDMT) against a control group receiving GDMT alone. The primary endpoint of this research was to evaluate the change in left ventricular ejection fraction (LVEF) after six months of treatment.

Key Findings and Outcomes

The results were promising; patients receiving C-MIC therapy exhibited statistically significant improvements across all primary and secondary endpoints. Specifically, the C-MIC group saw an average increase in LVEF of 6.6%, whereas the control group experienced only a 1.5% increase. This difference showcases the efficacy of introducing microcurrent therapy into treatment protocols, with a notable mean difference of 5.1% (95% CI 3.1–7.1; p < 0.001).

Further demonstrating the therapy's impact, 84% of patients receiving C-MIC therapy improved by at least one New York Heart Association (NYHA) functional class, in stark contrast to just 15% of control subjects, indicating a risk difference of 68.9% (95% CI 50.6–87.2; p < 0.001). Quality of life also saw remarkable enhancements, as 75% of participants receiving C-MIC achieved a significant improvement in the Kansas City Cardiomyopathy Questionnaire Overall Summary Score, again overshadowing the mere 15% from the control group (risk difference 60.0%; 95% CI 42.3–77.6; p < 0.001).

Additionally, physical functional capacity, measured by the six-minute walking distance, showed a substantial increase, with 47% of those treated reporting a 30% or more improvement compared to just 9% of control participants (risk difference 38.3%; 95% CI 14.4–62.2; p = 0.002). Most impressively, the C-MIC therapy was well-tolerated by participants, with no serious adverse events linked to the device.

Insights from Key Investigators

The ramifications of the C-MIC II study were discussed by leading figures in cardiology, with Prof. Jesus E. Rame emphasizing the transformative potential of microcurrent therapy. He remarked, “This study presents compelling evidence that microcurrent therapy can enhance both cardiac function and patient-centered outcomes in individuals with heart failure with reduced ejection fraction.” Meanwhile, Prof. Dragana N. Kosevic expressed encouragement over the meaningful improvements observed, hinting at a potential for broader adoption in clinical settings.

According to Prof. Jan Schmitto, the findings validate years of translational research and suggest that restoring myocardial bioelectric signaling significantly benefits cardiac performance, even in advanced heart failure cases. Prof. Stefan D. Anker, the senior author, reinforced the need for continued investigation into long-term clinical outcomes stemming from these findings.

Future Directions

John Brumfield, CEO of Berlin Heals, articulated a sense of excitement surrounding the publication of the C-MIC II trial results. He underscored the company’s commitment to innovating bioelectronic therapies targeting chronic heart failure by addressing underlying electrical and cellular issues.

As research in bioelectronic medicine progresses, the implications of this trial could pave the way for novel therapeutic avenues in treating heart failure, aiming to significantly improve patient quality of life and overall cardiac health. While the C-MIC device remains investigational and not yet approved for commercial use in most jurisdictions, the positive outcomes raise hopeful prospects for future advancements in treating heart conditions.