Abstract Body (Do not enter title and authors here): Background: Despite advances in management, heart failure (HF) is associated with the highest rates of hospitalization and rehospitalization among all chronic diseases, with hypervolemia being the main cause of hospital admissions. The Cordio HearO™ is a software medical device that remotely monitors HF patients’ fluid status by detecting changes in their recorded voice.
Methods: The DETECT-HF trial was a prospective, international, multicenter, single-arm, blinded, observational clinical study assessing the sensitivity and specificity of the HearO system to detect worsening HF events: HF hospitalizations and outpatient HF events requiring IV treatment (primary endpoint). The system is comprised of a smartphone-based mobile application, cloud-based analytics, and a web-based portal (not used in this study to maintain blinding). Daily voice recordings are used to establish a baseline and determine voice changes predictive of HF events, according to a predefined algorithm. True positives are defined as adjudicated HF events occurring within 31 days of the predefined voice change. Patients were followed until 78 adjudicated HF events occurred or up to 2 years. Secondary endpoints include overall incidence and severity of device-related adverse events and usability of the system.
Results: A total of 841 symptomatic HF patients were screened and 563 were enrolled at 47 sites including 37 in the US, 9 in Israel, and one in Spain. Baseline characteristics of the patients are presented in the Table. The prespecified number of events was reached in July 2025, and database lock occured on August 4, 2025.
Conclusions: The DETECT-HF trial will provide prospective data on the effectiveness of the HearO system for remote monitoring of HF patients in the home setting with the potential to reduce rehospitalizations and mortality.