Heart FailureVAPP-HFNCT07443670
Voice Analysis to Detect Pulmonary Arterial Pressure Changes in Heart Failure
An observational study of Heart Failure, run by Noah Labs at 3 sites in 2 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Daily Voice Recording
- How many people
- 60 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 12 Dec 2024to Sep 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Cognitive dysfunction limiting ability to perform daily voice recording
- Inability to read English or German
- Physical inability to use the recording device
Trial locations and contacts
3 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
3 sites in 2 countries
Germany2 sites
- Completed
BG Klinikum Unfallkrankenhaus Berlin, Dept. of Cardiology
Berlin, State of Berlin, 12683
- Completed
University Hospital Frankfurt, Dept. of Cardiology and Angiology
Frankfurt, 60590
United States1 site, 1 recruiting
- Recruiting
University of California, San Francisco (UCSF)
San Francisco, California, 94143
Shweta Motiwala, MD, (415) 502-4243, Mark.Lacsamana@ucsf.edu
About this study
Official title: Voice Analysis Using Artificial Intelligence to Detect Changes in Pulmonary Arterial Pressure in Patients With Heart Failure and an Implanted Pressure Sensor
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.
Read the 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.
- Conditions
- Heart Failure
- Being tested
- Daily Voice Recording
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Daily Voice RecordingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Daily Voice Recording |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
Secondary outcomes (3)
orrelation Between Voice Predictions and Clinical Events
Correlation between voice biomarker predictions and clinical outcomes including hospitalizations and diuretic adjustments.
Measured: 12 weeks
Predictive Accuracy of Machine Learning Models
Predictive accuracy of machine learning models for early detection of signs of heart failure decompensation, reported as area under the ROC curve.
Measured: 12 weeks
Adherence to Daily Voice Recording
Percentage of days with at least one transmitted voice recording over the 12-week study period.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2026
- Study start12 Dec 2024
- Primary completionMay 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Noah Labs
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07443670
- Sponsor's protocol ID
- 3
- Acronym
- VAPP-HF
- Status last verified
- Feb 2026
- First submitted
- 24 Feb 2026
- Last updated
- 2 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Voice Analysis Using Artificial Intelligence to Detect Changes in Pulmonary Arterial Pressure in Patients With Heart Failure and an Implanted Pressure Sensor
- ClinicalTrials.gov ID
- NCT07443670
- Acronym / sponsor ID
- VAPP-HF / 3
- Conditions
- Heart Failure
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Noah LabsIndustry (pharma, biotech, devices)
- Study start
- 12 Dec 2024 (actual)
- Primary completion
- May 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 2 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Groups and Interventions Use this module to add a description of each group or cohort in the study a | – | Other: Daily Voice RecordingHeart 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Daily Voice RecordingPatients 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. | Other | Groups and Interventions Use this module to add a description of each group or cohort in the study a |
Primary outcome
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.
3 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure, run by Noah Labs at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Germany, United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Leonhard Riehle, MD (+491715547970, leonhard.riehle@noah-labs.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity of AI Voice Analysis in Detecting PA Pressure Changes (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2026.