Pulmonary HypertensionNCT07311044
CVD/PH and Voice Characteristics
An observational study of Pulmonary Hypertension and Cardiovascular Diseases, run by Mayo Clinic at 1 site in United States.
Trial summary
The purpose of this study is to determine the association between patient voice signal characteristics and the presence and severity of pulmonary hypertension in patients referred for elective clinically indicated echocardiography for at Mayo Clinic MN. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Hypertension, Cardiovascular Diseases
- How many people
- 7,000 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jan 2021to Jan 2027
- How long will I take part?
- 1 Day
- 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: Subjects will be selected from a list of patients scheduled for a clinically indicated echocardiogram.
Who may be able to join
- All individuals who present for a routine elective, clinically indicated, diagnostic echocardiogram at the echocardiography laboratory at Mayo Clinic
- All individuals who have had a clinically indicated, diagnostic echocardiogram at the echocardiography lab at Mayo Clinic before a scheduled procedure in the cardiac catheterization lab at Mayo Clinic
- All individuals who have had a clinically indicated diagnostic echocardiogram at the echocardiography lab at Mayo Clinic and have an appointment in any CV outpatient clinic.
Who cannot join
- Known history of voice disorder either primary or secondary to neuromuscular or other pathology
- Patients under the age of 18 years
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Amir Lerman, M.D. contact
United States1 site, 1 recruiting
- Recruiting
Mayo Clinic
Rochester, Minnesota, 55905
Diana Albers, 507-255-6884, albers.diana2@mayo.edu
Amir Lerman, MD
About this study
Official title: Cardiovascular Disease/ Pulmonary Hypertension and Voice Characteristics Study
The purpose of this study is to determine the association between patient voice signal characteristics and the presence and severity of pulmonary hypertension in patients referred for elective clinically indicated echocardiography for at Mayo Clinic MN.
- Conditions
- Pulmonary Hypertension, Cardiovascular Diseases
- Medical subject headings
- Hypertension, Pulmonary, Cardiovascular Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of confirmed pulmonary hypertension diagnoses based on voice recording analysis
A successful diagnosis of pulmonary hypertension will be confirmed by echocardiogram.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2025
- Study start8 Jan 2021
- Primary completionJan 2027 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary HypertensionStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 7,000 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amir Lerman, Mayo Clinic
- Investigators
- Amir Lerman, M.D., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07311044
- Sponsor's protocol ID
- 20-011269
- Status last verified
- Dec 2025
- First submitted
- 16 Dec 2025
- Last updated
- 30 Dec 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 30 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiovascular Disease/ Pulmonary Hypertension and Voice Characteristics Study
- ClinicalTrials.gov ID
- NCT07311044
- Acronym / sponsor ID
- 20-011269
- Conditions
- Pulmonary Hypertension, Cardiovascular Diseases
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 7,000 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 8 Jan 2021 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 30 Dec 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 this study is to determine the association between patient voice signal characteristics and the presence and severity of pulmonary hypertension in patients referred for elective clinically indicated echocardiography for at Mayo Clinic MN.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects will be selected from a list of patients scheduled for a clinically indicated echocardiogram.
Key inclusion criteria (3 listed)
- All individuals who present for a routine elective, clinically indicated, diagnostic echocardiogram at the echocardiography laboratory at Mayo Clinic
- All individuals who have had a clinically indicated, diagnostic echocardiogram at the echocardiography lab at Mayo Clinic before a scheduled procedure in the cardiac catheterization lab at Mayo Clinic
- All individuals who have had a clinically indicated diagnostic echocardiogram at the echocardiography lab at Mayo Clinic and have an appointment in any CV outpatient clinic.
Key exclusion criteria (2 listed)
- Known history of voice disorder either primary or secondary to neuromuscular or other pathology
- Patients under the age of 18 years
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
Number of confirmed pulmonary hypertension diagnoses based on voice recording analysis
Time frame: Baseline
A successful diagnosis of pulmonary hypertension will be confirmed by echocardiogram.
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 30 Dec 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.
Amir Lerman, M.D. contact
Amir Lerman, 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 Pulmonary Hypertension and 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 2 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 30 Dec 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 Diana Albers (507-255-6884, albers.diana2@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of confirmed pulmonary hypertension diagnoses based on voice recording analysis (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 30 Dec 2025.