A Study of Hemodynamic Cardiopulmonary Exercise for CHD

March 3, 2026 updated by: Alexander C. Egbe, Mayo Clinic

Invasive Hemodynamic Cardiopulmonary Exercise Testing for Assessment of Patients With Congenital Heart Disease (Cath CHD)

The purpose of this study is to compare the difference in the ability to detect hemodynamic abnormalities between invasive hemodynamic assessments performed at rest versus exercise, to assess the correlation between invasive and noninvasive (Doppler-derived) rest-exercise hemodynamic indices and to compare the association between indices of disease severity and hemodynamic abnormalities identified at rest versus exercise.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Not Applicable

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 Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Recruiting
        • Mayo Clinic
        • Principal Investigator:
          • Alexander Egbe, M.B.B.S., M.P.H.

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

Description

Inclusion Criteria:

  • Congenital Heart Disease Diagnosis
  • Undergoing Clinically indicated Cardiac Cath

Exclusion Criteria:

  • Unable to consent
  • 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

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Patients Undergoing Clinically indicated Cardiac Cath
Procedure: Cardiac Cath
Patient will undergo standard of care Cardiac Cath and in addition invasive CPET (Cardiopulmonary exercise testing) will be performed during the procedure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in left ventricular end-systolic elastance from rest to peak exercise
Time Frame: Baseline
Change in left ventricular end-systolic elastance will be measured in ΔmmHg/mL
Baseline
Change in Left ventricular cardiac output from rest to peak exercise
Time Frame: Baseline
Change in left ventricular cardiac output will be measured in ΔL/min
Baseline
Change in systemic vascular resistance from rest to peak exercise
Time Frame: Baseline
Change in systemic vascular resistance will be measured in ΔWoods Units
Baseline
Change in right ventricular free-wall strain from rest to peak exercise
Time Frame: Baseline
Change in right ventricular free-wall strain will be measured in Δ%
Baseline
Change in right ventricular cardiac output from rest to peak exercise
Time Frame: Baseline
Change in right ventricular cardiac output will be measured in ΔL/min
Baseline
Change in pulmonary vascular resistance from rest to peak exercise
Time Frame: Baseline
Change in pulmonary vascular resistance will be measured in ΔWoods Units
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, M.B.B.S., M.P.H., 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)

February 10, 2025

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

August 20, 2024

First Submitted That Met QC Criteria

August 20, 2024

First Posted (Actual)

August 22, 2024

Study Record Updates

Last Update Posted (Actual)

March 5, 2026

Last Update Submitted That Met QC Criteria

March 3, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 24-004619
  • 5R01HL160761-03 (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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