Using daily voice recordings to spot pulmonary artery pressure changes in people with heart failure

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, multi-center observational study in which participants with implanted pulmonary artery (PA) pressure sensors provide daily voice recordings via a mobile app for 12 weeks while continuing standard PA pressure monitoring and heart failure care. Voice samples include sustained vowel sounds and a standardized reading passage and are collected on participants' smartphones or tablets. PA pressure readings obtained as part of routine care are paired with the voice data and analyzed retrospectively using classical machine learning and deep learning methods. The primary endpoint is the sensitivity and specificity of the AI-based voice analysis in detecting PA pressure changes at prespecified thresholds, and no clinical decisions are made based on voice results during the study.

Why it matters

Who can join: the full rules

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

Where it's running

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

Study contacts

• Study coordinator: Leonhard Riehle, MD
• Email: leonhard.riehle@noah-labs.com
• Phone: +491715547970

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.