View clinical trials related to Univentricular Heart.
Filter by:After successful Fontan surgery, the risk of mortality in childhood is only low. Unfortunately, some of the patients suffer from Fontan-typical long-term complications in the long-term course, whereby protein loss neuropathy must be mentioned in particular, which is described in the literature with an incidence of 3-14% (1, 2) and still has a 5-year risk of death of 6-12% today (2, 3). Protein loss tereopathy leads to loss of protein in the intestine and subsequently to diarrhea and edema. Other problems concern the liver, which can develop cirrhosis due to chronic congestion (4-6). Cardiac can lead to heart failure and arrhythmias. The registry study described in this protocol is intended to identify factors that influence the treatment outcome of patients in the Fontan circulation in the long term through systematic prospective documentation of the data from our standardized and guideline-oriented treatment.
Aim: to evaluate the effect of muscle strengthening exercise training in adults with Fontan circulation compared to healthy controls. Hypothesis: adults with Fontan circulation have a relatively lower effect of muscle strengthening exercise training compared to healthy controls.
This study will validate a coordinate-based 3-dimensional echocardiographic technique for the assessment of cardiac size and function in children and young adults with functional single ventricles.
This trial is being conducted to evaluate the effect of a small-group wellness education program combined with a longitudinal, individualized prescription exercise program on the wellness, resiliency, and daily activity levels of pediatric patients with Fontan physiology. There will be two phases for this project. The first phase is the "WE BEAT Group Wellness Education Program" and participants will be transitioned into the phase two HEART Club following phase one. The trial will look at feasibility and acceptability of the program. Additional hypothesis include home whether exercise interventions can: - be delivered without any associated serious cardiac events; - will result in a decreased proportion of patients who are categorized as frail when compared to the cohort's pre-test baseline. - will result in increased measured peak oxygen consumption when compared with their pre-intervention baseline. - will result in increased step counts measured monthly from baseline to end of intervention - will improve self-reported quality of life from baseline to post-intervention. - will result in increased patient reported activity level from baseline to post-intervention
Congenital heart disease (CHD) is the leading cause of birth defects, with an incidence of 0.8%. Among CHD, univentricular heart disease or "single ventricle" is rare and complex. As a result of the improved patient care over the last decades, the number of children and adults with single ventricle is increasing significantly. Today, the main challenge is to ensure an optimal follow-up of these new patients in order to improve their life expenctancy as well as their quality of life (QoL). Currently, echocardiography and cardiopulmonary exercice test (CPET) are central in management of patients with single ventricle as part of good clinical practice guidelines. Single ventricle volumes and function are very difficult to asses with conventional echocardiography because of their complex geometry. Indeed, single ventricle size and morphology vary depending on the patient characteristics and on the initial CHD (before surgical repair). That's why conventional 2D echocardiographic parameters are not reliable for single ventricle assessment. Magnetic resonance imaging (MRI) is more effective in assessing single ventricle volumes and function. Nevertheless, MRI is not universally available, is not practical in many situations, is expensive, and is a relative contraindication in patients with pacemakers. Over the past decade, the use of the 3D echocardiography has increased. This is an available tool that can assess ventricular function and volumes in few seconds. Recent studies shown a good correlation between 3D echocardiography and MRI for assessment of ventricular volumes and function in patient with CHD and especially in those with single ventricle. Moreover, according to some authors, CPET parameters are strongly correlated with risk of hospitalization, risk of death, physical activity and quality of life, especially in patients with single ventricle. To date, there is no study performed about the relationship between 3D echocardiography and CPET parameters in patients with single ventricle.
In literature, it has been reported that exercise capacity decreases in single-ventricle patients undergoing Fontan Procedure due to various factors related to surgery and underlying cardiac anomaly. Cardiopulmonary exercise test (CPET) was generally used to evaluate exercise capacity in children and adults with fontan circulation. The fact that CPET requires a clinically expert team and equipment and is more expensive does not always make it possible to perform routine cardiopulmonary exercise testing. In some cases, field tests evaluating submaximal and maximal exercise capacity may be more practical than cardiopulmonary exercise testing. Therefore, in this study, it is aimed to evaluate the exercise capacity of Fontan patients with 6-minute walking test and incremental shuttle walk test and to compare vital signs during the tests.
Infants and children with heart conditions require treatment in children's hospitals that are typically located in large cities. This creates challenges for children and families who need to travel long distances to come to appointments. Providing quality care to children with heart disease has further been challenged by the COVID-19 pandemic, with a shift towards decreased in-person contact and an increase in virtual visits, where assessment by doctors and nurses is more limited. This research study will look at how families of children with heart disease access care and how investigators can improve care with virtual technologies. This will involve testing a new home-based virtual care platform that uses Bluetooth technology to connect weight scales, oxygen measuring devices and blood pressure cuffs with a smartphone app, allowing parents to easily use these devices and send accurate data directly to the cardiology team. Investigators will obtain feedback from families, patients, and healthcare providers about how this helped or did not help them, and adjust the technology as needed to make it better.
After the Fontan procedure applied in patients with a functional or anatomical single ventricle, patients are faced with significant morbidity and mortality risk. Most of the common complications after Fontan such as arrhythmia, cyanosis, ventricular dysfunction, heart failure, atrioventricular valve insufficiency, protein-losing enteropathy, thrombosis, bleeding, venous insufficiency directly or indirectly limit exercise capacity. It has been reported that hemodynamic, vascular and muscular factors may be effective in the decrease of exercise capacity. In previous studies, it has been reported that cardiac output, one of the hemodynamic parameters, is the main factor affecting exercise capacity in patients with Fontan, and this is due to insufficient increase in stroke volume. In addition to the hemodynamic profile, the effects of muscle oxygenation, arterial stiffness and peripheral muscle strength on exercise capacity have been mentioned in different studies. For this reason, it is thought that examining the effects of hemodynamic, vascular and muscular profile together on submaximal and maximal exercise capacity in patients with Fontan will provide information about the mechanisms of influence of different exercise capacities and will provide important information in terms of determining exercise-based rehabilitation programs for such patients.
The purpose of the proposed study is to determine the safety of enhanced external counterpulsation (EECP), a system for compressing the blood vessels in the legs in synchrony with an individual's cardiac rhythm, in clinically well, adult Fontan patients, to document the acute hemodynamic and myocardial effects of EECP on the Fontan circulation, and to demonstrate acute changes in endothelial function after one hour of the procedure.
The purpose of this study is to non-invasively characterize the fibrotic consequences of single ventricle physiology, its possible solution and effect on lymphatics. This project investigates the response to acute imposition of Fontan hemodynamics by examining the interrelationship between liver and cardiac fibrosis/dysfunction and lymphatic congestion along with a pilot trial of the antifibrotic agent, spironolactone, to prevent these consequences and to determine if MRI can discern these differences. The combination of serum biomarkers and MRI form a powerful non-invasive tool in putting together this complicated web of dysfunction.