NCT06566196 · Mayo Clinic
A Study of Hemodynamic Cardiopulmonary Exercise for CHD
What this study is about
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.
View original scientific description
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
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.
Primary outcome measures
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
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Congenital Heart Disease Diagnosis
- Undergoing Clinically indicated Cardiac Cath
Exclusion criteria
- Unable to consent
Where
- Rochester, Minnesota
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 5, 2026 · Source of record for eligibility and locations