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A Study of Hemodynamic Cardiopulmonary Exercise for CHD

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06566196
Enrollment
200
Registered
2024-08-22
Start date
2025-02-10
Completion date
2026-12-01
Last updated
2026-03-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Congenital Heart Disease

Brief summary

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.

Interventions

PROCEDURECardiac Cath

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

Sponsors

Mayo Clinic
Lead SponsorOTHER
National Heart, Lung, and Blood Institute (NHLBI)
CollaboratorNIH

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Congenital Heart Disease Diagnosis * Undergoing Clinically indicated Cardiac Cath

Exclusion criteria

* Unable to consent * Pregnancy

Design outcomes

Primary

MeasureTime frameDescription
Change in left ventricular end-systolic elastance from rest to peak exerciseBaselineChange in left ventricular end-systolic elastance will be measured in ΔmmHg/mL
Change in Left ventricular cardiac output from rest to peak exerciseBaselineChange in left ventricular cardiac output will be measured in ΔL/min
Change in systemic vascular resistance from rest to peak exerciseBaselineChange in systemic vascular resistance will be measured in ΔWoods Units
Change in right ventricular free-wall strain from rest to peak exerciseBaselineChange in right ventricular free-wall strain will be measured in Δ%
Change in right ventricular cardiac output from rest to peak exerciseBaselineChange in right ventricular cardiac output will be measured in ΔL/min
Change in pulmonary vascular resistance from rest to peak exerciseBaselineChange in pulmonary vascular resistance will be measured in ΔWoods Units

Countries

United States

Contacts

CONTACTACHD Research Program
RSTACHDRESPRG@mayo.edu507-293-2565
PRINCIPAL_INVESTIGATORAlexander Egbe, M.B.B.S., M.P.H.

Mayo Clinic

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 6, 2026