Cardiovascular DiseasesNCT07224685
A Study of Mayo Clinic CV Research Heart & Voice Study
An observational study of Cardiovascular Diseases, run by Mayo Clinic at 1 site in United States.
Trial summary
The purpose of the study is to determine whether voice recordings acquired from patient-owned Android and Apple (iOS) smartphones can be used to monitor cardiovascular health. Voice signals will be processed to determine whether we can detect presence of cardiovascular disease and wellness, or if health risks exist. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases
- What is being tested?
- Voice Recording
- How many people
- 1,000,000 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Mar 2024to Mar 2029
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients who have the Mayo Clinic app and iOS 14 or Android smartphone (other types of smartphones will be added when functionality is added to the CDH app).
Who may be able to join
- Adult patients using the Mayo patient iPhone app and iOS 14.0 or later (determined automatically via Mayo software) and Apple Watch v 4 or later (not SE), or if they have Android device for voice
- Expressed interest in participation
- Signed HIPPA authorization
Who cannot join
- Age under 18
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
Amanda Priebe, 507-422-6932, Priebe.Amanda@mayo.edu
Paul Friedman, MD
About this study
Official title: Evaluation of Voice and ECG Transmission and AI Models Using Voice, ECG and Health Data Collected Using a Mayo Clinic Center for Digital Health (CDH)-Developed App for a Repository: Mayo Clinic CV Research for Heart & Voice Study
The purpose of the study is to determine whether voice recordings acquired from patient-owned Android and Apple (iOS) smartphones can be used to monitor cardiovascular health. Voice signals will be processed to determine whether we can detect presence of cardiovascular disease and wellness, or if health risks exist.
- Conditions
- Cardiovascular Diseases
- Being tested
- Voice Recording
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Voice RecordingOther
Patients will record a 30-second to 2-minute video pronouncing vowel sounds or reading a short script. This will occur every 14 days for up to five years.
| Study group | Role | What they receive |
|---|---|---|
| Adult patients using the Mayo patient iPhone app | Not described Receives: Other: Voice Recording |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Patients Who Recorded a Voice Sample
The total number of patients who recorded a voice sample will be defined as those completing a 30-second to 2-minute video, pronouncing vowel sounds or reading a short script as prompted by the Mayo Clinic App.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2025
- Study start5 Mar 2024
- Primary completionMar 2029 (estimated)
- Study completionMar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- 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
- 1,000,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paul A. Friedman, Mayo Clinic
- Investigators
- Paul Friedman, M.D., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07224685
- Sponsor's protocol ID
- 23-012146
- Status last verified
- Oct 2025
- First submitted
- 3 Nov 2025
- Last updated
- 5 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Voice and ECG Transmission and AI Models Using Voice, ECG and Health Data Collected Using a Mayo Clinic Center for Digital Health (CDH)-Developed App for a Repository: Mayo Clinic CV Research for Heart & Voice Study
- ClinicalTrials.gov ID
- NCT07224685
- Acronym / sponsor ID
- 23-012146
- Conditions
- Cardiovascular Diseases
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000,000 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 5 Mar 2024 (actual)
- Primary completion
- Mar 2029 (estimated)
- Study completion
- Mar 2029 (estimated)
- First posted
- 5 Nov 2025 (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.
The purpose of the study is to determine whether voice recordings acquired from patient-owned Android and Apple (iOS) smartphones can be used to monitor cardiovascular health. Voice signals will be processed to determine whether we can detect presence of cardiovascular disease and wellness, or if health risks exist.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adult patients using the Mayo patient iPhone app | – | Other: Voice Recording |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who have the Mayo Clinic app and iOS 14 or Android smartphone (other types of smartphones will be added when functionality is added to the CDH app).
Key inclusion criteria (3 listed)
- Adult patients using the Mayo patient iPhone app and iOS 14.0 or later (determined automatically via Mayo software) and Apple Watch v 4 or later (not SE), or if they have Android device for voice
- Expressed interest in participation
- Signed HIPPA authorization
Key exclusion criteria (1 listed)
- Age under 18
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 |
|---|---|---|
| Voice RecordingPatients will record a 30-second to 2-minute video pronouncing vowel sounds or reading a short script. This will occur every 14 days for up to five years. | Other | Adult patients using the Mayo patient iPhone app |
Primary outcome
Total Patients Who Recorded a Voice Sample
Time frame: Baseline
The total number of patients who recorded a voice sample will be defined as those completing a 30-second to 2-minute video, pronouncing vowel sounds or reading a short script as prompted by the Mayo Clinic App.
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 5 Nov 2025.
- 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.
Paul Friedman, M.D. principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases, run by Mayo Clinic at 1 site in United States.
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 1 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 5 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in 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 Amanda Priebe (507-422-6932, priebe.amanda@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Patients Who Recorded a Voice Sample (time frame: Baseline). 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 5 Nov 2025.