Breaking Barriers: Remote ECG Solution Enables A Fully Decentralized ME/CFS Phase 2 Clinical Trial

Myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) presents profound challenges for clinical trial participation due to the debilitating fatigue, cognitive dysfunction, and mobility limitations of patients. To overcome these barriers, Lindus Health conducted a fully decentralized Phase 2 trial, deploying a patient-centric, remote ECG monitoring solution.

Recognizing the need for secure and compliant cardiac data collection, Lindus Health partnered with AliveCor, utilizing the FDA-cleared KardiaMobile® 6L device. This portable technology enabled at-home ECG recording, integrated with CoreLab physician review and a GDPR- and HIPAA-compliant data infrastructure, ensuring data quality and privacy. By eliminating the need for in-person visits, the trial significantly expanded access for an underserved patient population, enhancing recruitment diversity and inclusivity. AliveCor’s real-time, high-fidelity ECG monitoring empowered remote clinical oversight without compromising trial integrity or regulatory compliance. This approach demonstrated the viability of decentralized cardiac safety assessments, reinforcing confidence among regulators and paving the way for more accessible research methodologies. Lindus Health’s success highlights the transformative potential of digital health tools in addressing longstanding accessibility challenges in ME/CFS research and beyond.