Heart FailureVOICE-HFNCT07870395
Voice-based Outcome Identification and Clinical Evaluation in Heart Failure
An observational study of Heart Failure and Chronic Heart Failure, run by Noah Labs.
Trial summary
VOICE-HF is a clinical study designed to evaluate the performance of a novel non-invasive software device (Noah Labs Vox) that uses vocal characteristics to estimate DHF risk and has strong potential for clinical success. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Heart Failure, Chronic Heart Failure, Chronic Heart Disease
- What is being tested?
- Daily Voice Recording
- Type of treatment
- Medical device
- How many people
- 450 participants
- Where
- No sites listed yet
- Study dates
- Oct 2026to Dec 2027
- 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 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Eligible participants will be adult patients (≥22 years) with Stage C heart failure of any etiology and LVEF who experienced a prior decompensated heart failure (DHF) event within 180 days before enrollment.
Who may be able to join
- Age ≥22
- HF diagnosis (Stage C)
- DHF event within prior 180 days
Who cannot join
- Monitoring with implantable volume or pressure monitoring devices, or
- Planned cardiac surgery or major intervention (e.g., LVAD or transplant), or
- Otherwise inability or unwillingness to comply with study procedures.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
VOICE-HF is a clinical study designed to evaluate the performance of a novel non-invasive software device (Noah Labs Vox) that uses vocal characteristics to estimate DHF risk and has strong potential for clinical success. This study will compare the performance of Noah Labs Vox with the contemporary performance of commonly used weight-based remote monitoring rules and applications to determine efficacy and safety.
Read the detailed description
VOICE-HF is a prospective, multicenter, single-arm observational study designed to evaluate the performance of the Noah Labs Vox algorithm using an independent test dataset. Noah Labs Vox is intended to detect signs of worsening in patients with heart failure before a Decompensated Heart Failure (DHF) event occurs that would require treatment intensification. To evaluate its technical performance, the VOICE-HF study will recruit approximately 450 participants with Stage C heart failure of any etiology and across the full range of left ventricular ejection fraction (LVEF) to complete daily smartphone based voice recordings for 180 days. The voice data will be collected prospectively via a dedicated mobile smartphone application, and performance will be interpreted in the context of DHF events as adjudicated by a Clinical Events Committee.
- Conditions
- Heart Failure, Chronic Heart Failure, Chronic Heart Disease
- 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 RecordingDevice
Patients use the mobile app daily to record voice samples and answer optional wellness and symptom-related questions. Voice recordings are analyzed by an algorithm, which extracts vocal biomechanical features. Results are not shared with clinicians and participants during the study and are analyzed retrospectively after study completion.
| Study group | Role | What they receive |
|---|---|---|
| Voice-Based Monitoring Group | All participants receive standard heart failure care as per local standard of care, plus daily voice monitoring via a mobile application. Patients record voice samples and answer symptom questions daily. Sites and participants are blinded to the results, which are analyzed retrospectively. Receives: Device: Daily Voice Recording |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance Outcome Measure
The co-primary objectives of the study are to evaluate the performance of the Noah Labs Vox algorithm in detecting heart failure decompensation events, in terms of sensitivity and unexplained alert rate.
Measured: From enrollment to the end of follow up of 6 months
Secondary outcomes (1)
Median Lead Time
The secondary objective of the study is to evaluate how early the Noah Labs Vox algorithm detects heart failure decompensation events, in terms of lead time prior to the event.
Measured: From enrollment to the end of the follow up period of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2026
- Study startOct 2026 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (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
- 450 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
- NCT07870395
- Sponsor's protocol ID
- VOICE-HF-001
- Acronym
- VOICE-HF
- Status last verified
- Oct 2026
- First submitted
- 6 Oct 2026
- Last updated
- 14 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Voice-based Outcome Identification and Clinical Evaluation in Heart Failure
- ClinicalTrials.gov ID
- NCT07870395
- Acronym / sponsor ID
- VOICE-HF / VOICE-HF-001
- Conditions
- Heart Failure, Chronic Heart Failure, Chronic Heart Disease
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- Noah LabsIndustry (pharma, biotech, devices)
- Study start
- Oct 2026 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 13 Oct 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.
VOICE-HF is a clinical study designed to evaluate the performance of a novel non-invasive software device (Noah Labs Vox) that uses vocal characteristics to estimate DHF risk and has strong potential for clinical success. This study will compare the performance of Noah Labs Vox with the contemporary performance of commonly used weight-based remote monitoring rules and applications to determine efficacy and safety.
Detailed description
VOICE-HF is a prospective, multicenter, single-arm observational study designed to evaluate the performance of the Noah Labs Vox algorithm using an independent test dataset. Noah Labs Vox is intended to detect signs of worsening in patients with heart failure before a Decompensated Heart Failure (DHF) event occurs that would require treatment intensification. To evaluate its technical performance, the VOICE-HF study will recruit approximately 450 participants with Stage C heart failure of any etiology and across the full range of left ventricular ejection fraction (LVEF) to complete daily smartphone based voice recordings for 180 days. The voice data will be collected prospectively via a dedicated mobile smartphone application, and performance will be interpreted in the context of DHF events as adjudicated by a Clinical Events Committee.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Voice-Based Monitoring Group | – | Device: Daily Voice RecordingAll participants receive standard heart failure care as per local standard of care, plus daily voice monitoring via a mobile application. Patients record voice samples and answer symptom questions daily. Sites and participants are blinded to the results, which are analyzed retrospectively. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Eligible participants will be adult patients (≥22 years) with Stage C heart failure of any etiology and LVEF who experienced a prior decompensated heart failure (DHF) event within 180 days before enrollment.
Key inclusion criteria (3 listed)
- Age ≥22
- HF diagnosis (Stage C)
- DHF event within prior 180 days
Key exclusion criteria (3 listed)
- Monitoring with implantable volume or pressure monitoring devices, or
- Planned cardiac surgery or major intervention (e.g., LVAD or transplant), or
- Otherwise inability or unwillingness to comply with study procedures.
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 use the mobile app daily to record voice samples and answer optional wellness and symptom-related questions. Voice recordings are analyzed by an algorithm, which extracts vocal biomechanical features. Results are not shared with clinicians and participants during the study and are analyzed retrospectively after study completion. | Device | Voice-Based Monitoring Group |
Primary outcome
Performance Outcome Measure
Time frame: From enrollment to the end of follow up of 6 months
The co-primary objectives of the study are to evaluate the performance of the Noah Labs Vox algorithm in detecting heart failure decompensation events, in terms of sensitivity and unexplained alert rate.
1 secondary outcome
Median Lead Time
Time frame: From enrollment to the end of the follow up period of 6 months
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 14 Oct 2026.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure and Chronic Heart Failure, run by Noah Labs.
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 3 inclusion and 3 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: opening soon, as of the sponsor's last update on 14 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
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, MD (+49 171 5547970, 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?
Performance Outcome Measure (time frame: From enrollment to the end of follow up of 6 months). 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 14 Oct 2026.