#Switzerland #Heart Failure #Zug #Berlin Heals #C-MIC II

Landmark Study Validates Microcurrent Therapy Effectiveness in Heart Failure

The recent publication of the C-MIC II trial findings in the European Journal of Heart Failure marks a significant milestone in heart failure treatment. Conducted by Berlin Heals and C-MIC II Investigators, the trial revealed impressive results regarding the efficacy of microcurrent therapy, particularly through the Cardio-Microcurrent (C-MIC) device, which offers a novel approach to treating patients with heart failure.

Overview of the C-MIC II Trial

The C-MIC II trial involved 70 ambulatory patients suffering from non-ischemic dilated cardiomyopathy with a left ventricular ejection fraction (LVEF) ranging from 25% to 35%. This randomized controlled trial compared the effects of C-MIC therapy alongside guideline-directed medical therapy (GDMT) with GDMT alone. The key focus was to measure the variation in LVEF over a 6-month period, with secondary measures including improvements in functional capacity and overall quality of life.

Results were compelling. Participants receiving microcurrent therapy had an average increase in LVEF of 6.6%, while the control group showed a modest rise of just 1.5%. This difference of 5.1% was statistically significant, affirming the therapy's clinical relevance. Additionally, noteworthy functional and quality-of-life enhancements were observed, with 84% of patients in the C-MIC group improving by at least one NYHA class versus only 15% in the control group.

Patients undergoing C-MIC therapy also showcased superior advancements in walking distance and overall health scores. Notably, 75% of these patients achieved substantial improvements in quality of life, contrasting sharply with the 15% of control respondents. Most excitingly, near half of those treated with the C-MIC device reported considerable gains in walking capability, emphasizing the broad-ranging benefits of the therapy. Importantly, the treatment was well-tolerated, showing no serious device-related adverse events amongst participants.

Expert Insights

The findings have garnered praise from many experts in the field. Prof. Jesus E. Rame, a leading investigator, commented on the study’s significance, underscoring how it furnishes vital evidence that microcurrent therapy can notably enhance cardiac function while improving patient-reported outcomes. He noted that this innovative therapy opens new potential for patients who continue to experience symptoms despite optimal conventional treatment.

Co-principal investigator, Prof. Dragana N. Kosevic, expressed excitement over the vital improvements in patient symptoms and functional capabilities observed in this collaborative study. Prof. Jan Schmitto also emphasized the importance of these results, reinforcing over ten years of research aimed at adapting bioelectric signaling to improve cardiac health in patients suffering from advanced heart failure.

Even more importantly, Prof. Stefan D. Anker highlighted that this research represents the first randomized trial establishing the benefits of low-level microcurrent stimulation for structural heart function and enhanced quality of life. He believes this lays a solid groundwork for subsequent studies focused on long-term effects of such treatments.

A New Horizon for Heart Failure Treatments

In summary, the publication of C-MIC II's results has stirred excitement within the medical community and heralded a potentially transformative phase in the treatment of heart failure. John Brumfield, CEO of Berlin Heals, expressed his delight at the publication, revealing that the results align perfectly with the company's mission to pioneer innovative bioelectronic therapies aimed at addressing chronic heart failure from its fundamental electrical and cellular issues.

For further information, the full C-MIC II study can be accessed through the European Journal of Heart Failure here. These promising results advocate for the broader application of C-MIC therapy, paving the way for future clinical advancements that could significantly improve the lives of individuals battling heart failure.

Disclaimer: The C-MIC device remains investigational and is not yet approved for commercial use. Its safety and effectiveness continue to be evaluated.