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RECRUITINGOBSERVATIONAL

Voice Analysis to Detect Pulmonary Arterial Pressure Changes in Heart Failure

Voice Analysis Using Artificial Intelligence to Detect Changes in Pulmonary Arterial Pressure in Patients With Heart Failure and an Implanted Pressure Sensor

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - Age 18 years or older - Successful implantation of a PA pressure sensor and monitored by a participating study center - Willingness to record a short predefined text daily for 3 months using a smartphone or tablet - Ability to comfortably read aloud the study passage in English or German - Written willing to sign a consent form obtained Who Should NOT Join This Trial: - Pregnant, breastfeeding, or unwilling to practice birth control during participation - Condition that in the opinion of the investigator would compromise patient safety or data quality - Pathological voice changes due to surgery or injury - Planned invasive cardiac procedures during the study period - COPD requiring home oxygen therapy - Chronic kidney disease requiring dialysis - Cognitive dysfunction limiting ability to perform daily voice recording - Inability to read English or German - Physical inability to use the recording device Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * Age 18 years or older * Successful implantation of a PA pressure sensor and monitored by a participating study center * Willingness to record a short predefined text daily for 3 months using a smartphone or tablet * Ability to comfortably read aloud the study passage in English or German * Written informed consent obtained Exclusion Criteria: * Pregnant, breastfeeding, or unwilling to practice birth control during participation * Condition that in the opinion of the investigator would compromise patient safety or data quality * Pathological voice changes due to surgery or injury * Planned invasive cardiac procedures during the study period * COPD requiring home oxygen therapy * Chronic kidney disease requiring dialysis * Cognitive dysfunction limiting ability to perform daily voice recording * Inability to read English or German * Physical inability to use the recording device

Treatments Being Tested

OTHER

Daily Voice Recording

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.

Locations (3)

University of California, San Francisco (UCSF)
San Francisco, California, United States
BG Klinikum Unfallkrankenhaus Berlin, Dept. of Cardiology
Berlin, State of Berlin, Germany
University Hospital Frankfurt, Dept. of Cardiology and Angiology
Frankfurt, Germany