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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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Mentioned in the study description

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 12 weeks

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
Compensation
Mentioned in the study description
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether AI can use daily voice recordings to spot pressure changes in the arteries that carry blood to the lungs. It is for adults with heart failure who have an implanted sensor that measures this pressure. Participants record their voice with a mobile app for 12 weeks while getting their usual care; voice results do not guide their care during the study.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be at least 18 years old.
  • Have a successfully implanted lung artery pressure sensor and be monitored by a study center.
  • Be willing to record a short, set passage each day for 3 months using a smartphone or tablet.
  • Be able to comfortably read the study passage aloud in English or German.
  • Give written consent to join the study.

Who can't join

  • Be pregnant, breastfeeding, or unwilling to use birth control during the study.
  • Have a condition the study doctor thinks could affect your safety or the quality of the study data.
  • Have abnormal voice changes caused by surgery or injury.
  • Have a planned heart procedure that goes inside the body during the study.
  • Have COPD, a long-term lung disease, that requires oxygen at home.
  • Have long-term kidney disease that requires dialysis, a treatment that filters the blood.
  • Have memory or thinking problems that limit daily recording, or be physically unable to use the recording device.
  • Be unable to read English or German.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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

Study sites (1)

CA