Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06566196

A Study of Hemodynamic Cardiopulmonary Exercise for 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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Congenital Heart Disease Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Heart Defects, Congenital Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location status: Recruiting

Location contact

Alexander Egbe, M.B.B.S., M.P.H.

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Congenital Heart Disease Diagnosis
  • Undergoing Clinically indicated Cardiac Cath

Exclusion criteria

  • Unable to consent
  • Pregnancy

Treatment and study plan

Cardiac Cath

Procedure

Patient will undergo standard of care Cardiac Cath and in addition invasive CPET (Cardiopulmonary exercise testing) will be performed during the procedure.

Primary outcomes

  1. 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

  2. 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

  3. Change in systemic vascular resistance from rest to peak exercise

    Time frame: Baseline

    Change in systemic vascular resistance will be measured in ΔWoods Units

  4. 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%

  5. 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

  6. Change in pulmonary vascular resistance from rest to peak exercise

    Time frame: Baseline

    Change in pulmonary vascular resistance will be measured in ΔWoods Units

Study contacts

Contact information is provided by the study sponsor or research team.

ACHD Research Program

CONTACT

[email protected]

507-293-2565

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 22, 2024
Registry last updated
Mar 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.