A Study of Hemodynamic Cardiopulmonary Exercise for CHD
Invasive Hemodynamic Cardiopulmonary Exercise Testing for Assessment of Patients With Congenital Heart Disease (Cath CHD)
2 other identifiers
interventional
200
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2025
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 20, 2024
CompletedFirst Posted
Study publicly available on registry
August 22, 2024
CompletedStudy Start
First participant enrolled
February 10, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2026
March 5, 2026
March 1, 2026
1.8 years
August 20, 2024
March 3, 2026
Conditions
Outcome Measures
Primary Outcomes (6)
Change in left ventricular end-systolic elastance from rest to peak exercise
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
Change in left ventricular cardiac output will be measured in ΔL/min
Baseline
Change in systemic vascular resistance from rest to peak exercise
Change in systemic vascular resistance will be measured in ΔWoods Units
Baseline
Change in right ventricular free-wall strain from rest to peak exercise
Change in right ventricular free-wall strain will be measured in Δ%
Baseline
Change in right ventricular cardiac output from rest to peak exercise
Change in right ventricular cardiac output will be measured in ΔL/min
Baseline
Change in pulmonary vascular resistance from rest to peak exercise
Change in pulmonary vascular resistance will be measured in ΔWoods Units
Baseline
Study Arms (1)
Patients Undergoing Clinically indicated Cardiac Cath
EXPERIMENTALInterventions
Patient will undergo standard of care Cardiac Cath and in addition invasive CPET (Cardiopulmonary exercise testing) will be performed during the procedure.
Eligibility Criteria
You may qualify if:
- Congenital Heart Disease Diagnosis
- Undergoing Clinically indicated Cardiac Cath
You may not qualify if:
- Unable to consent
- Pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mayo Cliniclead
- National Heart, Lung, and Blood Institute (NHLBI)collaborator
Study Sites (1)
Mayo Clinic
Rochester, Minnesota, 55905, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Alexander Egbe, M.B.B.S., M.P.H.
Mayo Clinic
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
August 20, 2024
First Posted
August 22, 2024
Study Start
February 10, 2025
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
December 1, 2026
Last Updated
March 5, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share