Congenital Heart DiseaseNCT06566196
A Study of Hemodynamic Cardiopulmonary Exercise for CHD
A study testing Cardiac Cath in people with Congenital Heart Disease, run by Mayo Clinic at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Congenital Heart Disease
- What is being tested?
- Cardiac Cath
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Feb 2025to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Congenital Heart Disease Diagnosis
- Undergoing Clinically indicated Cardiac Cath
Who cannot join
- Unable to consent
- Pregnancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Mayo Clinic
Rochester, Minnesota, 55905
Alexander Egbe, M.B.B.S., M.P.H.
About this study
Official title: 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.
- Conditions
- Congenital Heart Disease
- Being tested
- Cardiac Cath
- Medical subject headings
- Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac CathProcedure or surgery
Patient will undergo standard of care Cardiac Cath and in addition invasive CPET (Cardiopulmonary exercise testing) will be performed during the procedure.
| Study group | Role | What they receive |
|---|---|---|
| Patients Undergoing Clinically indicated Cardiac Cath | Experimental | Not described Receives: Procedure: Cardiac Cath |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline
Change in Left ventricular cardiac output from rest to peak exercise
Change in left ventricular cardiac output will be measured in ΔL/min
Measured: Baseline
Change in systemic vascular resistance from rest to peak exercise
Change in systemic vascular resistance will be measured in ΔWoods Units
Measured: 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%
Measured: Baseline
Change in right ventricular cardiac output from rest to peak exercise
Change in right ventricular cardiac output will be measured in ΔL/min
Measured: Baseline
Change in pulmonary vascular resistance from rest to peak exercise
Change in pulmonary vascular resistance will be measured in ΔWoods Units
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2024
- Study start10 Feb 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Heart DiseaseStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Alexander C. Egbe, Mayo Clinic
- Investigators
- Alexander Egbe, M.B.B.S., M.P.H., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06566196
- Sponsor's protocol ID
- 24-004619
- Other IDs
- 5R01HL160761-03
- Status last verified
- Mar 2026
- First submitted
- 20 Aug 2024
- Last updated
- 5 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Invasive Hemodynamic Cardiopulmonary Exercise Testing for Assessment of Patients With Congenital Heart Disease (Cath CHD)
- ClinicalTrials.gov ID
- NCT06566196
- Acronym / sponsor ID
- 24-004619
- Conditions
- Congenital Heart Disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 10 Feb 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 22 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients Undergoing Clinically indicated Cardiac Cath | Experimental | Procedure: Cardiac Cath |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Congenital Heart Disease Diagnosis
- Undergoing Clinically indicated Cardiac Cath
Key exclusion criteria (2 listed)
- Unable to consent
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardiac CathPatient will undergo standard of care Cardiac Cath and in addition invasive CPET (Cardiopulmonary exercise testing) will be performed during the procedure. | Procedure or surgery | Patients Undergoing Clinically indicated Cardiac Cath |
Primary outcome
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
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
Change in systemic vascular resistance from rest to peak exercise
Time frame: Baseline
Change in systemic vascular resistance will be measured in ΔWoods Units
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%
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
Change in pulmonary vascular resistance from rest to peak exercise
Time frame: Baseline
Change in pulmonary vascular resistance will be measured in ΔWoods Units
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Alexander Egbe, M.B.B.S., M.P.H. principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cardiac Cath in people with Congenital Heart Disease, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact ACHD Research Program (507-293-2565, RSTACHDRESPRG@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in left ventricular end-systolic elastance from rest to peak exercise (time frame: Baseline). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2026.