Heart FailureVAMP-HFNCT06566911
Voice Analysis for Monitoring Patients With Heart Failure
An observational study of Heart Failure, run by Noah Labs at 2 sites in 2 countries.
Trial summary
This observational study involves ADHF patients at two sites in the United States and Germany. After informed consent and screening assessments, participants will perform daily voice recordings during their hospital stay, from admission until discharge. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- How many people
- 70 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 24 Jan 2024to Sep 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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: The study population includes adult patients, aged 18 and older, hospitalized with acutely decompensated heart failure, irrespective of left ventricular ejection fraction.
Who may be able to join
- Clinically diagnosed with Acutely Decompensated Heart Failure.
- At least 18 years of age.
Who cannot join
- Disabling mental diseases (e.g., Alzheimer's disease)
- Clinically diagnosed chronic obstructive pulmonary disease (COPD)
- Treatment in ICU or IMU
- Dialysis treatment
- Previous operations on organs involved in generation of voice (vocal tract, vocal folds, etc.)
- Neurodegenerative diseases
- Pregnancy
- Inability to provide consent
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site, 1 recruiting
- Recruiting
Mayo Clinic
Rochester, Minnesota, 55902
Soumya Vungarala, MD
About this study
Official title: A Pilot Study on AI-Based Voice Analysis for Monitoring Patients Hospitalized With Acute Decompensated Heart Failure
This observational study involves ADHF patients at two sites in the United States and Germany. After informed consent and screening assessments, participants will perform daily voice recordings during their hospital stay, from admission until discharge. Alongside voice data, additional clinical information such as left ventricular ejection fraction, NTpro-BNP levels, and ECG-data will be collected for comprehensive analysis. The study's goal is to identify voice-based indicators of heart failure progression, with the potential to enhance remote monitoring and self-management strategies for heart failure patients.
- Conditions
- Heart Failure
- Medical subject headings
- Heart Failure
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in vocal characteristics from admission to discharge and their correlation with heart failure severity markers.
The primary endpoint is the change in vocal characteristics from admission to discharge, and its correlation with clinical markers of heart failure severity, such as weight change from admission to discharge, NTpro-BNP levels, ECG-parameters, and left ventricular ejection fraction (LVEF).
Measured: Hospital stay
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2024
- Study start24 Jan 2024
- Primary completionSep 2024 (estimated)
- Study completionSep 2024 (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
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Noah Labs
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Charite University, Berlin, Germany, Mayo Clinic
- Responsible party
- Sponsor
- Investigators
- Gerhard Hindricks, MD, Principal investigator, German Heart Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06566911
- Sponsor's protocol ID
- 23-011322
- Acronym
- VAMP-HF
- Status last verified
- Aug 2024
- First submitted
- 15 Aug 2024
- Last updated
- 22 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study on AI-Based Voice Analysis for Monitoring Patients Hospitalized With Acute Decompensated Heart Failure
- ClinicalTrials.gov ID
- NCT06566911
- Acronym / sponsor ID
- VAMP-HF / 23-011322
- Conditions
- Heart Failure
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Noah LabsIndustry (pharma, biotech, devices)
- Collaborators
- Charite University, Berlin, Germany, Mayo Clinic
- Study start
- 24 Jan 2024 (actual)
- Primary completion
- Sep 2024 (estimated)
- Study completion
- Sep 2024 (estimated)
- First posted
- 22 Aug 2024 (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.
This observational study involves ADHF patients at two sites in the United States and Germany. After informed consent and screening assessments, participants will perform daily voice recordings during their hospital stay, from admission until discharge. Alongside voice data, additional clinical information such as left ventricular ejection fraction, NTpro-BNP levels, and ECG-data will be collected for comprehensive analysis. The study's goal is to identify voice-based indicators of heart failure progression, with the potential to enhance remote monitoring and self-management strategies for heart failure patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population includes adult patients, aged 18 and older, hospitalized with acutely decompensated heart failure, irrespective of left ventricular ejection fraction.
Key inclusion criteria (2 listed)
- Clinically diagnosed with Acutely Decompensated Heart Failure.
- At least 18 years of age.
Key exclusion criteria (8 listed)
- Disabling mental diseases (e.g., Alzheimer's disease)
- Clinically diagnosed chronic obstructive pulmonary disease (COPD)
- Treatment in ICU or IMU
- Dialysis treatment
- Previous operations on organs involved in generation of voice (vocal tract, vocal folds, etc.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in vocal characteristics from admission to discharge and their correlation with heart failure severity markers.
Time frame: Hospital stay
The primary endpoint is the change in vocal characteristics from admission to discharge, and its correlation with clinical markers of heart failure severity, such as weight change from admission to discharge, NTpro-BNP levels, ECG-parameters, and left ventricular ejection fraction (LVEF).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2024.
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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. This study is not recruiting at the moment.
Gerhard Hindricks, MD principal investigator
German Heart Institute
2 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 2 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 2 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 22 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Germany. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Leonhard Riehle, MD (+49 32 221093495, 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?
Change in vocal characteristics from admission to discharge and their correlation with heart failure severity markers. (time frame: Hospital stay). 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 22 Aug 2024.