Cardiopulmonary Exercise for Congenital Heart Disease
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Mayo Clinic
No Placebo Group
Approved in 4 jurisdictions
Trial Summary
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.
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.
12345Is 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.
14678How 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.
124910Eligibility 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.
Participant Groups
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.
1Treatment groups
Experimental Treatment
Group I: Patients Undergoing Clinically indicated Cardiac CathExperimental Treatment1 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
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
Mayo ClinicRochester, MN
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Who is running the clinical trial?
Mayo ClinicLead Sponsor
National Heart, Lung, and Blood Institute (NHLBI)Collaborator
References
Evaluation of the relationship between cardiopulmonary exercise test findings and clinical status in children and adolescents with congenital heart disease. [2023]The cardiopulmonary exercise test is accepted as a helpful diagnostic tool in risk stratification, evaluation of prognosis, and guiding treatment modality in adults with congenital heart disease. In this study, we present our experience with the use of cardiopulmonary exercise test in children with congenital heart disease in different physiological and anatomical classifications.
Cardiopulmonary Exercise Testing in Adult Congenital Heart Disease. [2018]Recently, the number of patients with congenital heart diseases reaching adulthood has been progressively increasing in developed countries, and new issues are emerging: the evaluation of their capacity to cope with physical activity and whether this knowledge can be used to optimize medical management. A symptom-limited cardiopulmonary exercise test has proven to be an essential tool, because it can objectively evaluate the functional cardiovascular capacity of these patients, identify the pathological mechanisms of the defect (circulatory failure, shunts, and/or pulmonary hypertension), and help prescribe an individualized rehabilitation program when needed. The common findings on cardiopulmonary exercise testing in patients with congenital heart diseases are a reduced peak [Formula: see text]o2, an early anaerobic threshold, a blunted heart rate response, a reduced increase of Vt, and an increased [Formula: see text]e/[Formula: see text]co2. All these measures suggest common pathophysiological abnormalities: (1) a compromised exercise capacity from anomalies affecting the heart, vessels, lungs, or muscles; (2) chronotropic incompetence secondary to cardiac autonomic dysfunction or β-blockers and antiarrhythmic therapy; and (3) ventilatory inefficiency caused by left-heart failure with pulmonary congestion, pulmonary hypertension, pulmonary obstructive vascular disease, or cachexia. Most of these variables also have prognostic significance. For these patients, cardiopulmonary exercise testing allows evaluation and decisions affecting lifestyle and therapeutic interventions.
Comprehensive use of cardiopulmonary exercise testing identifies adults with congenital heart disease at increased mortality risk in the medium term. [2012]Parameters of cardiopulmonary exercise testing were recently identified as strong predictors of mortality in adults with congenital heart disease. We hypothesized that combinations of cardiopulmonary exercise testing parameters may provide optimal prognostic information on midterm survival in this population.
Physiologic decrease of ventilatory response to exercise in the second decade of life in healthy children. [2011]Cardiopulmonary exercise testing is increasingly used in children with congenital heart defects. Because of changes related to growth, the interpretation of exercise test results heavily relies on the presence of normative data. There is growing interest in the assessment of the ventilatory response to exercise in children with congenital heart disease, but normative data are lacking.
Cardiopulmonary stress testing in children and adults with congenital heart disease. [2014]Cardiopulmonary exercise stress testing (CPET) is a vital tool used to assess patients with a history of congenital heart disease. There are several tests in the cardiologist's armamentarium that allow for assessment of cardiac anatomy and function. The majority of these tests are only performed with the body at rest and some even require sedation. Exercise stress testing is unique in allowing assessment of the hemodynamic status of a patient in motion. In addition to providing all the information obtained during an exercise stress test, such as heart rate, rhythm, ST-segment analysis, and blood pressure, the CPET provides critical metabolic information. Parameters such as VO2, oxygen pulse, and VE/VCO2 slope help to detail the patient's physiology in a dynamic state. Decisions can then be better made regarding follow-up plans, acceptable exercise recommendations, and future interventions, if necessary. It allows insight into the patient's exercise capacity and quality of life. Norms for both children and adults with many forms of congenital heart disease are now available allowing appropriate comparisons to be made. This review will discuss in detail the CPET and its application in congenital heart disease.
Safety and efficacy of exercise training in children and adolescents with congenital heart disease: A systematic review and descriptive analysis. [2023]While exercise training is beneficial in the prevention and management of many chronic diseases, the role of exercise training in children and adolescents with congenital heart disease is less understood. We sought to determine the safety and efficacy of exercise training in children and adolescents with congenital heart disease.
A home-based exercise program for children with congenital heart disease following interventional cardiac catheterization: study protocol for a randomized controlled trial. [2018]Cardiac catheterization has opened an innovative treatment field for cardiac disease; this treatment is becoming the most popular approach for pediatric congenital heart disease (CHD) and has led to a significant growth in the number of children with cardiac catheterization. Unfortunately, based on evidence, it has been demonstrated that the majority of children with CHD are at an increased risk of "non-cardiac" problems. Effective exercise therapy could improve their functional status significantly. As studies identifying the efficacy of exercise therapy are rare in this field, the aims of this study are to (1) identify the efficacy of a home-based exercise program to improve the motor function of children with CHD with cardiac catheterization, (2) reduce parental anxiety and parenting burden, and (3) improve the quality of life for parents whose children are diagnosed with CHD with cardiac catheterization through the program.
Exercise testing for assessment of heart failure in adults with congenital heart disease. [2021]Congenital heart disease (CHD)-related heart failure is common and associated with significant morbidity, mortality, and resource utilization. In adults with CHD (ACHD), exercise limitation is often underestimated. Quantitative assessment with cardiopulmonary exercise testing (CPET) provides a comprehensive evaluation of exercise capacity and can help risk stratify patients, particularly across serial testing. CPET parameters must be interpreted within the context of the underlying anatomy, specifically for patients with either single ventricle physiology and/or cyanosis. Acknowledging differences in CPET parameters between ACHD and non-ACHD patients with heart failure are also important considerations when evaluating the overall benefit of advanced heart failure therapies. CPET testing can also guide safe exercise recommendation, including those with ACHD-related heart failure.
[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]There are few data available on applying the cardiopulmonary exercise test for evaluation of cardiac exercise capacity in adult patients with congenital heart diseases. The aim of the study was to perform this test in adults with Ebstein anomaly and patients with patent ASD II (atrial septal defect) and determination of potential relationships between these parameters and echocardiographically assessed hemodynamic indices.
Cardiopulmonary exercise testing in healthy children and adolescents at moderately high altitude. [2021]Cardiopulmonary exercise testing is a tool that helps clinicians to establish diagnosis and calculate risk stratification in adults. However, the utility of this test among children with congenital heart disease has not been fully explored. The goal of this study was to describe reference values for cardiopulmonary performance of healthy children.