--- title: Voice Analysis to Detect Pulmonary Arterial Pressure Changes in Heart Failure nct_id: NCT07443670 overall_status: RECRUITING sponsor: Noah Labs study_type: OBSERVATIONAL primary_condition: Heart Failure countries: United States, Germany canonical_url: "https://parkinsonspathways.com/agent/trials/NCT07443670.md" clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT07443670" ct_last_update_post_date: 2026-03-02 last_seen_at: "2026-05-12T07:04:53.914Z" source: ClinicalTrials.gov (mirrored, no enrichment) --- # Voice Analysis to Detect Pulmonary Arterial Pressure Changes in Heart Failure **Official Title:** Voice Analysis Using Artificial Intelligence to Detect Changes in Pulmonary Arterial Pressure in Patients With Heart Failure and an Implanted Pressure Sensor **NCT ID:** [NCT07443670](https://clinicaltrials.gov/study/NCT07443670) ## Key Facts - **Status:** RECRUITING - **Study Type:** OBSERVATIONAL - **Target Enrollment:** 60 - **Lead Sponsor:** Noah Labs - **Conditions:** Heart Failure - **Start Date:** 2024-12-12 - **Completion Date:** 2026-09 - **CT.gov Last Update:** 2026-03-02 ## 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. ## Detailed Description Implanted PA pressure sensors enable early detection of heart failure decompensation but are costly and invasive. Fluid retention in heart failure may affect the vocal apparatus, producing measurable voice changes that could serve as a non-invasive alternative for monitoring pulmonary congestion. Participants record daily voice samples consisting of sustained vowel sounds and a standardized reading passage via the Noah Labs mobile app. PA pressure readings are collected daily per standard care. Voice recordings and clinical data are analyzed retrospectively using classical machine learning and deep learning approaches. No additional clinical visits are required. ## Eligibility - **Minimum age:** 18 Years - **Sex:** ALL - **Healthy Volunteers:** No ``` 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 ``` ## 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** (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. ## Primary Outcomes - **Sensitivity of AI Voice Analysis in Detecting PA Pressure Changes** _(time frame: 12 weeks)_ — Sensitivity and specificity of the AI-based voice analysis algorithm in detecting pulmonary arterial pressure changes at pre-specified thresholds. ## Secondary Outcomes - **orrelation Between Voice Predictions and Clinical Events** _(time frame: 12 weeks)_ - **Predictive Accuracy of Machine Learning Models** _(time frame: 12 weeks)_ - **Adherence to Daily Voice Recording** _(time frame: 12 weeks)_ ## Locations (3) - 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_ ## Recent Field Changes (last 30 days) - `status.overallStatus` — added _(2026-05-12)_ - `status.primaryCompletionDate` — added _(2026-05-12)_ - `status.completionDate` — added _(2026-05-12)_ - `status.lastUpdatePostDate` — added _(2026-05-12)_ - `design.enrollmentCount` — added _(2026-05-12)_ - `eligibility.criteria` — added _(2026-05-12)_ - `eligibility.minAge` — added _(2026-05-12)_ - `eligibility.sex` — added _(2026-05-12)_ - `outcomes.primary` — added _(2026-05-12)_ - `outcomes.secondary` — added _(2026-05-12)_ - `armsInterventions.arms` — added _(2026-05-12)_ - `armsInterventions.interventions` — added _(2026-05-12)_ - `sponsor.lead` — added _(2026-05-12)_ - `results.hasResults` — added _(2026-05-12)_ - `locations.university of california, san francisco (ucsf)|san francisco|california|united states` — added _(2026-05-12)_ - `locations.bg klinikum unfallkrankenhaus berlin, dept. of cardiology|berlin|state of berlin|germany` — added _(2026-05-12)_ - `locations.university hospital frankfurt, dept. of cardiology and angiology|frankfurt||germany` — added _(2026-05-12)_ --- *Canonical: https://parkinsonspathways.com/agent/trials/NCT07443670.md* *Source data (authoritative): https://clinicaltrials.gov/study/NCT07443670* *This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*