CVD/PH and Voice Characteristics

December 16, 2025 updated by: Amir Lerman, Mayo Clinic

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

7000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Recruiting
        • Mayo Clinic
        • Contact:
        • Principal Investigator:
          • Amir Lerman, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Subjects will be selected from a list of patients scheduled for a clinically indicated echocardiogram.

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Known history of voice disorder either primary or secondary to neuromuscular or other pathology
  • Patients under the age of 18 years

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: Amir Lerman, M.D., Mayo Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 8, 2021

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

January 1, 2027

Study Registration Dates

First Submitted

December 16, 2025

First Submitted That Met QC Criteria

December 16, 2025

First Posted (Actual)

December 30, 2025

Study Record Updates

Last Update Posted (Actual)

December 30, 2025

Last Update Submitted That Met QC Criteria

December 16, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20-011269

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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