Registry for Mayo Clinic Adult Congenital Heart Disease Control Population

March 10, 2026 updated by: Alexander C. Egbe, Mayo Clinic

Control Population for the Mayo Clinic Adult Congenital Heart Disease Registry

This research study is being done to provide comparative data to the Mayo Clinic Adult Congenital Heart Disease Registry.

Study Overview

Status

Active, not recruiting

Conditions

Study Type

Observational

Enrollment (Actual)

66

Contacts and Locations

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

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic Minnesota

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

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Subjects will be healthy individuals with no history of cardiovascular disease selected from Mayo Clinic in Rochester, Minnesota.

Description

Inclusion Criteria:

  • BMI ≤ 30.
  • No current cardiac medications.
  • Systolic BP ≤ 140 mmHg.
  • Diastolic BP ≤ 90 mmHg.
  • Capacity to consent.

Exclusion Criteria:

  • To be assessed via EMR screening.
  • Patient confirmation during screening visit.
  • Screening tests as applicable.
  • History of cardiovascular disease. eGFR < 30.
  • Current orthopedic limitations.

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
Peak Oxygen Uptake
Time Frame: 6 Months
Peak Oxygen Uptake (L/min) : 1.7 ± 0.1
6 Months
Peak Right Ventricular - Pulmonary Coupling
Time Frame: 6 Months
Peak Right Ventricular - Pulmonary Coupling: (|%|/mmHg): 0.786 ± 0.065
6 Months

Collaborators and Investigators

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

Sponsor

Mayo Clinic

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)
National Institutes of Health (NIH)

Investigators

  • Principal Investigator: Alexander Egbe, MBBS, MPH, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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 6, 2022

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

March 10, 2023

First Submitted That Met QC Criteria

March 10, 2023

First Posted (Actual)

March 17, 2023

Study Record Updates

Last Update Posted (Actual)

March 12, 2026

Last Update Submitted That Met QC Criteria

March 10, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 21-011938
  • R01HL158517 (U.S. NIH Grant/Contract)

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

product manufactured in and exported from the U.S.

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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