Heart Failure Clinical Trials

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

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Other
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
California
University of California, San Francisco (UCSF)
RECRUITING
San Francisco
Other Locations
Germany
BG Klinikum Unfallkrankenhaus Berlin, Dept. of Cardiology
COMPLETED
Berlin
University Hospital Frankfurt, Dept. of Cardiology and Angiology
COMPLETED
Frankfurt
Contact Information
Primary
Leonhard Riehle, MD
leonhard.riehle@noah-labs.com
+491715547970
Time Frame
Start Date: 2024-12-12
Estimated Completion Date: 2026-09
Participants
Target number of participants: 60
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Noah Labs

This content was sourced from clinicaltrials.gov