Noah Labs
VOICE-HF is a clinical study designed to evaluate the performance of a novel non-invasive software device (Noah Labs Vox) that uses vocal characteristics to estimate DHF risk and has strong potential for clinical success. This study will compare the performance of Noah Labs Vox with the contemporary performance of commonly used weight-based remote monitoring rules and applications to determine efficacy and safety.
VOICE-HF is a prospective, multicenter, single-arm observational study designed to evaluate the performance of the Noah Labs Vox algorithm using an independent test dataset. Noah Labs Vox is intended to detect signs of worsening in patients with heart failure before a Decompensated Heart Failure (DHF) event occurs that would require treatment intensification. To evaluate its technical performance, the VOICE-HF study will recruit approximately 450 participants with Stage C heart failure of any etiology and across the full range of left ventricular ejection fraction (LVEF) to complete daily smar…
Inclusion Criteria: * Age ≥22 * HF diagnosis (Stage C) * DHF event within prior 180 days Exclusion Criteria: * Monitoring with implantable volume or pressure monitoring devices, or * Planned cardiac surgery or major intervention (e.g., LVAD or transplant), or * Otherwise inability or unwillingness to comply with study procedures.
Patients use the mobile app daily to record voice samples and answer optional wellness and symptom-related questions. Voice recordings are analyzed by an algorithm, which extracts vocal biomechanical features. Results are not shared with clinicians and participants during the study and are analyzed retrospectively after study completion.
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