NCT07311044

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7,000

participants targeted

Target at P75+ for all trials

Timeline
7mo left

Started Jan 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress91%
Jan 2021Jan 2027

Study Start

First participant enrolled

January 8, 2021

Completed
4.9 years until next milestone

First Submitted

Initial submission to the registry

December 16, 2025

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 30, 2025

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2027

Last Updated

December 30, 2025

Status Verified

December 1, 2025

Enrollment Period

6 years

First QC Date

December 16, 2025

Last Update Submit

December 16, 2025

Conditions

Pulmonary HypertensionCardiovascular Diseases

Outcome Measures

Primary Outcomes (1)

  • Number of confirmed pulmonary hypertension diagnoses based on voice recording analysis

    A successful diagnosis of pulmonary hypertension will be confirmed by echocardiogram.

    Baseline

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

RECRUITING

MeSH Terms

Conditions

Hypertension, PulmonaryCardiovascular Diseases

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesHypertensionVascular Diseases

Study Officials

  • Amir Lerman, M.D.

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Diana Albers

CONTACT

507-255-6884albers.diana2@mayo.edu

Amir Lerman, M.D.

CONTACT

lerman.amir@mayo.edu

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 16, 2025

First Posted

December 30, 2025

Study Start

January 8, 2021

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

January 1, 2027

Last Updated

December 30, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations

US(1)