VAPP-HF is a prospective, multi-center, observational study assessing whether daily voice recordings analyzed by a machine learning algorithm can detect changes in pulmonary arterial (PA) pressure in heart failure patients with implanted PA pressure sensors (e.g., CardioMEMS, Cordella). Patients across three sites in Germany and the United States provide daily voice recordings via a mobile app for 12 weeks while continuing standard PA pressure monitoring and heart failure care. Voice data is analyzed retrospectively after study completion; no clinical decisions are based on voice analysis during the study. The primary endpoint is the sensitivity and specificity of the AI-based voice analysis in detecting PA pressure changes at defined thresholds.
Implanted PA pressure sensors enable early detection of heart failure decompensation but are costly and invasive. Fluid retention in heart failure may affect the vocal apparatus, producing measurable voice changes that could serve as a non-invasive alternative for monitoring pulmonary congestion. Participants record daily voice samples consisting of sustained vowel sounds and a standardized reading passage via the Noah Labs mobile app. PA pressure readings are collected daily per standard care. Voice recordings and clinical data are analyzed retrospectively using classical machine learning and deep learning approaches. No additional clinical visits are required.
Study Type
OBSERVATIONAL
Enrollment
60
Patients record daily voice samples (sustained vowels and a standardized reading passage) using the Noah Labs mobile app. PA pressure readings are collected daily per standard care using the implanted sensor. Voice recordings are analyzed retrospectively using machine learning algorithms after study completion.
University of California, San Francisco (UCSF)
San Francisco, California, United States
RECRUITINGBG Klinikum Unfallkrankenhaus Berlin, Dept. of Cardiology
Berlin, State of Berlin, Germany
COMPLETEDUniversity Hospital Frankfurt, Dept. of Cardiology and Angiology
Frankfurt, Germany
COMPLETEDSensitivity of AI Voice Analysis in Detecting PA Pressure Changes
Sensitivity and specificity of the AI-based voice analysis algorithm in detecting pulmonary arterial pressure changes at pre-specified thresholds.
Time frame: 12 weeks
orrelation Between Voice Predictions and Clinical Events
Correlation between voice biomarker predictions and clinical outcomes including hospitalizations and diuretic adjustments.
Time frame: 12 weeks
Predictive Accuracy of Machine Learning Models
Predictive accuracy of machine learning models for early detection of signs of heart failure decompensation, reported as area under the ROC curve.
Time frame: 12 weeks
Adherence to Daily Voice Recording
Percentage of days with at least one transmitted voice recording over the 12-week study period.
Time frame: 12 weeks
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