Cardiopulmonary Exercise for Congenital Heart Disease

Overseen By ACHD Research Program

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Disqualifiers: Unable to consent, Pregnancy

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate how well different methods detect heart issues in people with congenital heart disease, comparing tests conducted at rest and during exercise. The focus is on a procedure called cardiac catheterization, which helps doctors assess heart function. People with congenital heart disease already scheduled for a cardiac cath might be suitable for this study. The goal is to enhance understanding of heart health and improve care for those with congenital heart conditions. As an unphased trial, this study offers a unique opportunity to advance heart health research and improve care for future patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that cardiac catheterization is safe for patients with congenital heart disease?

Research has shown that cardiac catheterization is generally safe, with major complications occurring in less than 1% of cases. The risk of death during the procedure is very low, approximately 0.05%, indicating that most people tolerate it well.

Recent studies indicate that the risk of serious problems, such as a stroke, is below 1%. This suggests that cardiac catheterization is a dependable and relatively safe option for those considering participation in a study involving this procedure. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using cardiac catheterization (cardiac cath) for congenital heart disease because it offers a more direct and detailed assessment of heart function compared to traditional methods like echocardiograms or MRIs. While most treatments focus on managing symptoms or correcting defects through surgery, cardiac cath provides real-time data that can help tailor treatment plans for individual patients. This technique allows doctors to measure pressures and oxygen levels within the heart, which can lead to more precise interventions and potentially improved outcomes for patients with congenital heart issues.

What evidence suggests that cardiac catheterization is effective for congenital heart disease?

This trial will focus on patients undergoing clinically indicated cardiac catheterization. Studies have shown that cardiac catheterization effectively checks heart conditions, especially in individuals born with heart defects. It helps doctors measure blood flow and pressure inside the heart, facilitating problem detection. Research has shown that this procedure can be performed safely in many locations, including countries with fewer resources. Experts agree that cardiac catheterization is a valuable tool for diagnosing and managing heart issues in both children and adults. This procedure reliably aids in understanding heart function and planning treatments. ^{3 6 7 8 9}

Who Is on the Research Team?

Alexander Egbe, MBBS, MPH

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for individuals with heart disease, specifically congenital heart defects. Participants should be able to perform exercise as part of the study but specific inclusion and exclusion criteria are not provided.

Inclusion Criteria

I am scheduled for a heart catheterization.

I have been diagnosed with a heart condition present since birth.

Exclusion Criteria

I am unable to give consent by myself.

Pregnancy

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Invasive Hemodynamic Assessment

Participants undergo invasive hemodynamic assessments at rest and during exercise to detect hemodynamic abnormalities

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the assessments

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Cardiac Cath

Trial Overview The study aims to compare how well invasive hemodynamic assessments can detect abnormalities at rest versus during exercise. It also looks at the correlation between these invasive tests and noninvasive Doppler-derived indices.

How Is the Trial Designed?

Group I: Patients Undergoing Clinically indicated Cardiac Cath Experimental Treatment 1 Intervention

Cardiac Cath is already approved in United States, European Union, Canada, Japan for the following indications:

Approved in United States as Cardiac Catheterization for:

• Diagnosis of coronary artery disease
• Assessment of cardiac function
• Evaluation of heart valve disorders

Approved in European Union as Cardiac Catheterization for:

• Diagnosis of coronary artery disease
• Assessment of cardiac function
• Evaluation of heart valve disorders
• Preoperative evaluation for cardiac surgery

Approved in Canada as Cardiac Catheterization for:

• Diagnosis of coronary artery disease
• Assessment of cardiac function
• Evaluation of heart valve disorders

Approved in Japan as Cardiac Catheterization for:

• Diagnosis of coronary artery disease
• Assessment of cardiac function
• Evaluation of heart valve disorders

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Published Research Related to This Trial

A study of 243 children with congenital heart defects found that the ventilatory response to exercise, measured by the VE/VCO2 slope, decreases progressively from ages 10 to 16, particularly in boys.

The research established gender-specific percentiles for VE/VCO2 slopes, suggesting that these percentiles should be used for interpreting exercise test results in this age group instead of relying on absolute values.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physiologic decrease of ventilatory response to exercise in the second decade of life in healthy children. Giardini, A., Odendaal, D., Khambadkone, S., et al.[2011]

Cardiopulmonary exercise stress testing (CPET) is a crucial tool for assessing patients with congenital heart disease, as it evaluates their heart function and hemodynamic status during physical activity, unlike many other tests that are done at rest.

CPET provides valuable metabolic data, such as VO2 and oxygen pulse, which helps in understanding a patient's exercise capacity and quality of life, and aids in making informed decisions about their treatment and exercise recommendations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardiopulmonary stress testing in children and adults with congenital heart disease. Miliaresis, C., Beker, S., Gewitz, M.[2014]

Cardiopulmonary exercise testing is crucial for assessing the physical capacity of adults with congenital heart diseases, helping to identify specific cardiovascular issues and tailor rehabilitation programs accordingly.

Common findings from these tests include reduced exercise capacity and abnormal heart and lung responses, which can inform medical management and predict patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardiopulmonary Exercise Testing in Adult Congenital Heart Disease. Mantegazza, V., Apostolo, A., Hager, A.[2018]

This study established reference values for cardiopulmonary performance in 103 healthy children aged 4 to 18 years, demonstrating that cardiopulmonary exercise testing is safe and effective for young children, even as young as 4 years old.

Key predictors of peak oxygen uptake were identified, including age, gender, height, and exercise time, with strong correlations found, allowing for the development of regression equations that can help compare healthy children to those with congenital heart disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardiopulmonary exercise testing in healthy children and adolescents at moderately high altitude. Ilarraza-Lomelí, H., Castañeda-López, J., Myers, J., et al.[2021]

Cardiopulmonary exercise testing (CPET) is crucial for accurately assessing exercise capacity in adults with congenital heart disease (ACHD), helping to identify limitations that are often underestimated.

CPET results must be interpreted considering the specific heart anatomy of ACHD patients, as this can influence their exercise capacity and guide safe exercise recommendations, particularly for those with heart failure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise testing for assessment of heart failure in adults with congenital heart disease. Burstein, DS., Menachem, JN., Opotowsky, AR.[2021]

This study will evaluate the effectiveness of a home-based exercise program for 300 children with congenital heart disease (CHD) who have undergone cardiac catheterization, aiming to improve their motor function and overall quality of life.

The trial will also assess the impact of the exercise program on reducing parental anxiety and caregiver burden, highlighting the potential benefits not just for the children but also for their families.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A home-based exercise program for children with congenital heart disease following interventional cardiac catheterization: study protocol for a randomized controlled trial. Du, Q., Salem, Y., Liu, HH., et al.[2018]

In a study of 25 children and adolescents with congenital heart disease, the cardiopulmonary exercise test proved to be an effective noninvasive tool for assessing exercise capacity and guiding treatment decisions, particularly in patients with borderline symptoms.

Results showed that patients with less severe heart failure (modified Ross classification groups I-II) had significantly better exercise performance metrics compared to those in more severe groups, indicating the test's utility in risk stratification and prognosis evaluation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of the relationship between cardiopulmonary exercise test findings and clinical status in children and adolescents with congenital heart disease. Çetiner, N., Çeliker, A.[2023]

In a study of 1375 adult patients with congenital heart disease, key cardiopulmonary exercise testing parameters like peak oxygen consumption and heart rate reserve were found to be strong predictors of midterm survival, with 117 patients dying during a median follow-up of 5.8 years.

The combination of peak oxygen consumption and heart rate reserve offered the best prognostic information, but this value was less significant in patients with a peak respiratory exchange ratio below 1.0, highlighting the need for tailored prognostic approaches based on individual patient characteristics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comprehensive use of cardiopulmonary exercise testing identifies adults with congenital heart disease at increased mortality risk in the medium term. Inuzuka, R., Diller, GP., Borgia, F., et al.[2012]

Adults with Ebstein anomaly and patent ASD II have significantly reduced exercise capacity compared to healthy controls, as shown by lower maximum oxygen uptake and heart rate during exercise tests.

The reduction in exercise capacity correlates with the severity of the disease, particularly in Ebstein anomaly, indicating that right ventricular overload plays a key role in limiting physical performance in these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Cardiopulmonary exercise test in the evaluation of exercise capacity in patients with Ebstein anomaly and patent ostium secundum atrial septal defect aged over 30 years]. Trojnarska, O., Gwizdała, A., Oko-Sarnowska, Z., et al.[2016]

Exercise training is safe for children and adolescents with congenital heart disease, with no reported adverse events linked to the interventions across 6 trials involving 642 participants.

The training showed efficacy in improving physical fitness, with significant enhancements in exercise capacity and cardiorespiratory fitness in several studies, although the evidence quality is considered low to moderate.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and efficacy of exercise training in children and adolescents with congenital heart disease: A systematic review and descriptive analysis. Anderson, CAJ., Suna, JM., Keating, SE., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11198277/

Congenital Cardiac Catheterization in Low- and Middle ... This study demonstrates that congenital cardiac catheterization is safely performed in LMICs. Future work addressing predictors of SAEs and adverse procedural ...

2. jacc.org jacc.org/doi/10.1016/j.jacadv.2025.101649

Comparative Cardiac Catheterization Registry: US vs LICs This study compares patient characteristics and outcomes of CCC in the US-based Congenital Cardiac Catheterization Project on Outcomes (C3PO)

3. ahajournals.org ahajournals.org/doi/10.1161/JAHA.121.022832

Procedural Risk in Congenital Cardiac Catheterization ... This study aims to modernize patient hemodynamic and procedural risk classification through the creation of risk assessment tools to be used in congenital ...

4. jscai.org jscai.org/article/S2772-9303(23)01183-3/fulltext

Expert Consensus Statement on Cardiac Catheterization ... Expert consensus statement on cardiac catheterization for pediatric patients and adults with congenital heart disease.

5. sciencedirect.com sciencedirect.com/science/article/pii/S1936879821021749

Catheterization in Adults With Congenital Heart Disease The authors provide a primer for cardiac catheterization procedures in adults with congenital heart disease, reviewing key procedural components ...

6. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK531461/

Cardiac Catheterization Risks and Complications - NCBI - NIH The risk of major complications during diagnostic cardiac catheterization procedure is usually less than 1%, and the risk and the risk of mortality of 0.05% for ...

7. ahajournals.org ahajournals.org/doi/10.1161/CIRCINTERVENTIONS.119.007791

Safety and Risk of Major Complications With Diagnostic ... Even the more recent data from the National Cardiovascular Data Registry (NCDR) reported <1% risk of stroke, salvage or emergent coronary artery ...

8. jacc.org jacc.org/doi/10.1016/j.jacc.2014.09.045

Procedural Results and Safety of Common Interventional ... The reported procedure was performed in >95% of catheterizations. Stated outcomes were accomplished in >98% of ASD and PDA procedures, but less ...

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11993852/

Cardiac Catheterization and Interventions in Pediatric Patients ... Survival to hospital discharge was 53.2% overall, 45.2% in patients with SV, and 56.8% in patients with 2 ventricles. Interventional procedures ...