A Study of Invasive Hemodynamic for MACHD Registry

April 29, 2026 updated by: Alexander C. Egbe, Mayo Clinic

Invasive Hemodynamic Control Cohort for The Mayo Clinic Adult Congenital Heart Disease (MACHD) Registry

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

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

50

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

  • Name: ACHD Research Program
  • Phone Number: (507) 293-2565

Study Contact Backup

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Recruiting
        • Mayo Clinic Rochester
        • Contact:
          • ACHD Research Program
          • Phone Number: (507) 293-2565
        • Contact:
        • Principal Investigator:
          • Alexander Egbe, MBBS, MPH

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

Yes

Sampling Method

Non-Probability Sample

Study Population

Healthy individuals without cardiac conditions will be recruited from Mayo Clinic in Rochester, MN.

Description

Inclusion Criteria:

  • Capacity to Consent
  • BMI </= 30
  • Systolic BP </= 140mmHg
  • Diastolic BP </= 90
  • eGFR > 30 (within prior 3 months) to confirm kidney function
  • Able to undergo an MRI

Exclusion Criteria:

  • History of Cardiovascular disease that may affect the results of the testing performed.
  • Any Current orthopedic limitations
  • Currently taking any cardiac medication
  • Pregnancy

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
Pulmonary vascular reserve
Time Frame: Baseline
The slope of mean pulmonary artery pressure / cardiac output (mPAP/CO)
Baseline

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)

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)

October 16, 2023

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

April 27, 2023

First Submitted That Met QC Criteria

April 27, 2023

First Posted (Actual)

May 8, 2023

Study Record Updates

Last Update Posted (Actual)

May 5, 2026

Last Update Submitted That Met QC Criteria

April 29, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 23-001939
  • R01HL160761 (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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