Recruiting

Observational Study

Sponsor:

Noah Labs

Code:

NCT07443670

Conditions

Heart Failure

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Daily Voice Recording

Study Details

Brief summary:

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.

Conditions

Heart Failure

Study ID

NCT07443670

Start date

Dec 12, 2024

Status verified date

Feb, 2026

Completion date

Sep, 2026

Anticipated

Primary completion date

May, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

60 participants

Anticipated

Interventions and Outcome Measures

Arms

Groups and Interventions Use this module to add a description of each group or cohort in the study a

Heart failure patients with implanted PA pressure sensors providing 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; no clinical decisions are based on voice analysis during the study.

Interventions

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.

Primary outcome measure

  • Sensitivity of AI Voice Analysis in Detecting PA Pressure Changes [ Time Frame: 12 weeks ]

Central Contacts and Locations

Central contacts

Leonhard Riehle, MD

+491715547970leonhard.riehle@noah-labs.com

Locations

University of California, San Francisco (UCSF)

Recruiting

San Francisco, California, United States, 94143

Contacts

Shweta Motiwala, MD

(415) 502-4243Mark.Lacsamana@ucsf.edu

More Information

Sponsor

Noah Labs

Last update posted

Mar 2, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Noah Labs on 2026-03-02.