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

Trial Summary

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 data supports the effectiveness of the treatment Cardiac Cath, Cardiac Catheterization, Cardiac Angiography for congenital heart disease?

Cardiopulmonary exercise testing is a valuable tool for assessing patients with congenital heart disease, as it helps evaluate their exercise capacity and identify any heart or lung issues. This testing can guide treatment decisions and improve management of the condition, suggesting that related procedures like cardiac catheterization and angiography may also be beneficial in understanding and treating congenital heart disease. ^{1 2 3 4 5}

Is cardiopulmonary exercise safe for people with congenital heart disease?

Exercise training, including cardiopulmonary exercise, is generally considered safe for children and adolescents with congenital heart disease, as it can help improve their health and manage their condition. ^{1 4 6 7 8}

How does cardiac catheterization differ from other treatments for congenital heart disease?

Cardiac catheterization is unique because it involves inserting a thin tube into a blood vessel to diagnose or treat heart conditions, providing direct access to the heart and blood vessels. This approach is different from other treatments that might rely on external imaging or medication, as it allows for precise intervention and assessment of the heart's function. ^{1 2 4 9 10}

What is the purpose of this trial?

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.

Research Team

Alexander Egbe, MBBS, MPH

Principal Investigator

Mayo Clinic

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

1. Turkey 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. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Cardiopulmonary Exercise Testing in Adult Congenital Heart Disease. [2018]

3. United States 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. [2012]

4. United States pubmed.ncbi.nlm.nih.gov

Physiologic decrease of ventilatory response to exercise in the second decade of life in healthy children. [2011]

5. United States pubmed.ncbi.nlm.nih.gov

Cardiopulmonary stress testing in children and adults with congenital heart disease. [2014]

6. United States 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. [2023]

7. England 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. [2018]

8. United States pubmed.ncbi.nlm.nih.gov

Exercise testing for assessment of heart failure in adults with congenital heart disease. [2021]

9. Poland 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]. [2016]

10. Mexico pubmed.ncbi.nlm.nih.gov

Cardiopulmonary exercise testing in healthy children and adolescents at moderately high altitude. [2021]