Voice Analysis to Detect Pulmonary Arterial Pressure Changes in Heart Failure

NCT07443670 | Recruiting

• 1 other identifier: 3
• Study Type: observational
• Target: 60
• Locations: 2 countries
• Sites: 3

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

Outcome Measures

Primary Outcomes (1)

• Sensitivity of AI Voice Analysis in Detecting PA Pressure Changes

  Sensitivity and specificity of the AI-based voice analysis algorithm in detecting pulmonary arterial pressure changes at pre-specified thresholds.

  12 weeks

Secondary Outcomes (3)

• orrelation Between Voice Predictions and Clinical Events

  12 weeks

• Predictive Accuracy of Machine Learning Models

  12 weeks

• Adherence to Daily Voice Recording

  12 weeks

Study Arms (1)

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.

Other: Daily Voice Recording

Interventions

Daily Voice Recording OTHER

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.

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults aged 18 years or older with chronic heart failure and a successfully implanted pulmonary arterial pressure sensor, monitored at participating centers in Germany and the United States.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Noah Labs: lead

Study Sites (3)

University of California, San Francisco (UCSF)

San Francisco, California, 94143, United States

RECRUITING

BG Klinikum Unfallkrankenhaus Berlin, Dept. of Cardiology

Berlin, State of Berlin, 12683, Germany

COMPLETED

University Hospital Frankfurt, Dept. of Cardiology and Angiology

Frankfurt, 60590, Germany

COMPLETED

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Central Study Contacts

Leonhard Riehle, MD

CONTACT

+491715547970; leonhard.riehle@noah-labs.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2026
• First Posted: March 2, 2026
• Study Start: December 12, 2024
• Primary Completion: May 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: March 2, 2026

Record last verified: 2026-02

Locations

DE (2); US (1)