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Congenital Heart Disease clinical trials

View clinical trials related to Congenital Heart Disease.

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NCT ID: NCT03931096 Completed - Clinical trials for Congenital Heart Disease

Quality of Life Assessment of Children With Congenital Heart Disease Aged 5 to 7 Years

QoL-CHD-5-7
Start date: February 1, 2019
Phase:
Study type: Observational

Congenital heart diseases (CHD) are the firt cause of congenital malformations (8 for 1000 births). Since the 90's, great advances in prenatal diagnosis, pediatric cardiac surgery, intensive care, and cardiac catheterization have reduced morbidity and early mortality in this population. Prevalence of " GUCH ", grown-ups with congenital heart disease has thus been significantly increasing. Nowadays, quality of life (QoL) assessment of this population is in the foreground. Our team is a reference center in the management of patient with CHD, from the fetal period to adulthood. The investigators have been conducting a clinical research program on health related QoL in pediatric and congenital heart disease. The investigators thus demonstrated the link between cardiopulmonary fitness and QoL in children with CHD aged 8 to 18 years, the correlation between functional class and QoL in adults with CHD, and the impact of therapeutic education on QoL in children under anticoagulants. Currently, no controlled cross-sectional quality of life study assessment has been leaded in the youngest children with CHD. This present study therefore extends our work in younger children aged 5 to 7 years.

NCT ID: NCT03917706 Completed - Clinical trials for Congenital Heart Disease

Development of a Quality of Life Assessment Tool for Adult Patients With a Congenital Heart Disease, Having Had Surgery During Childhood

Start date: April 1, 2018
Phase:
Study type: Observational

The mortality due to congenital heart diseases has decreased in recent decades, even for infants with the most complex lesions.Therapeutic advances have prolonged the lifespan of people with these diseases. However, there are specific social and psychological troubles that appear later in life and can compromise employability, insurability and social integration. There are different types of congenital heart disease: those not operated in adulthood, and those operated for curative or palliative purposes. It is estimated that about 10 out of 1000 babies are born with a congenital cardiac malformation. One-third of these have a critical diagnosis requiring a surgical intervention. Data from the literature show that there is an unusually high prevalence of psychosocial, neurological, developmental and psychiatric disabilities among survivors, as they enter formal education.There are many factors that influence developmental outcomes at school age. Early intervention is an essential element in controlling these comorbidities. The continuous monitoring of the development by a multidisciplinary team would make it possible to identify a developmental disorder as soon as it appears and respond to it as quickly as possible.For many children and their families, the burden of the developmental consequences is higher than the daily impact of the heart disease. Most studies and measures of quality of life in congenital heart patients require methodological improvements.They contribute little to the scientific basis of the quality of life in these patients. Future quality of life studies must invest in rigorous conceptualization, adequate operational definition and a good measure of quality of life. The investigators propose to develop a reproducible and reliable quality of life measurement tool, suitable for adult patients suffering from congenital heart disease and having had surgery during childhood.

NCT ID: NCT03913520 Completed - Clinical trials for Congenital Heart Disease

Outcome of Patients With Congenital Heart Disease

OUTCARDIOP
Start date: April 28, 2019
Phase: N/A
Study type: Interventional

Advanced surgical and medical healthcare systems have resulted in an increased prevalence of children and adults with congenital heart disease in Western countries. These patients often necessitate non-cardiac interventions. Previous studies have demonstrated that these patients are at increased risk of morbidity and mortality when presenting for non-cardiac interventions. The aim of this study is to know the prevalence of patients with congenital heart disease presenting for non-cardiac interventions in a tertiary hospital and to determine their outcome.

NCT ID: NCT03912025 Completed - Clinical trials for Congenital Heart Disease

The Relationship Between Having a Positive Mindset and Exercise Capacity in Patients With Congenital Heart Disease

Start date: January 30, 2020
Phase:
Study type: Observational

A cross sectional study utilizing congenital heart disease patients presenting for clinically indicated cardiopulmonary exercise test. Baseline questionnaires (see below) will be administered prior to the exercise test. Exercise test data and clinical data will be recorded. Questionnaire data will be compared to clinical data in and between disease severity groups. Disease severity will be determined based on hemodynamic (not anatomic) classification according to an algorithm adapted from the European Society of Cardiology.

NCT ID: NCT03886935 Completed - Clinical trials for Congenital Heart Disease

Metabolic Remodeling in Fontan Patients

Start date: January 1, 2017
Phase:
Study type: Observational

Assessment of metabolic alterations in adult Fontan patients with a dominant left ventricle with the help of serum examinations (Metabolomics). The aim is to find a tool for the completion of the (semi-)invasive monitoring of Fontan hemodynamics.

NCT ID: NCT03882788 Completed - Clinical trials for Congenital Heart Disease

The Effect of Anesthesia on Neurodevelopmental Outcome (NDO)

NDO
Start date: April 22, 2013
Phase: N/A
Study type: Interventional

The purpose of this study is to assess whether the type of anesthesia, narcotic-based versus inhalational anesthesia administered during cardiopulmonary bypass (CPB) surgery contributes to the wide variation in neurologic recovery and developmental outcome after surgery in infants with congenital heart disease.

NCT ID: NCT03877965 Completed - Clinical trials for Congenital Heart Disease

Pharmacokinetics and Safety Profile of Digoxin in Infants With Single Ventricle Congenital Heart Disease

DGX01
Start date: August 5, 2019
Phase:
Study type: Observational

This is a prospective, multi-center, open-label, PK and safety profile study of enteral digoxin in children <6 months old at time of enrollment, post-surgical or hybrid stage 1 palliation, but prior to surgical stage 2 palliation.

NCT ID: NCT03867903 Completed - Clinical trials for Congenital Heart Disease

BabySparks Developmental Application Pilot Study

Start date: March 14, 2019
Phase:
Study type: Observational

A single site, cross-sectional, pilot study of a mHealth application. Primary Objective This purpose of this pilot study is to evaluate mHealth adherence to a developmental application, Babysparks©, by parents of infants with complex congenital cardiac disease and single ventricle heart disease. Secondary Objective(s) -To determine the demographic and infant characteristics that correlate with mHealth adherence. -The rate of developmental progress of milestones while using the application will also be compared between infants with single ventricle cardiac disease and bi-ventricular cardiac disease. Research Intervention(s)/ Investigational Agent(s) Babysparks© developmental application is the main intervention with evaluation on feasibility of the mHealth application in a pediatric cardiology population. Study participants will be parents of infants with single ventricle and bi-ventricular complex congenital heart disease who underwent cardiac surgery in the first six weeks of life and are currently less than 18 months of age. Study Population There are approximately 150 new patients a year who have undergone cardiac surgery, with an additional 150 who are 18 months of age or less. Sample Size A maximum of 400 families/year Study Duration for Individual Participants Study participants will be monitored for a minimum of 6 months with the use of the BabySparks© App; to a maximum of 24 months of use of the app or when the child reaches a developmental age of 24 months, whichever occurs first. Study Specific Abbreviations/ Definitions mHealth : mobile health CHD: Congenital heart disease

NCT ID: NCT03854149 Completed - Clinical trials for Congenital Heart Disease

Apixaban in Adults With Congenital Heart Disease and Atrial Arrhythmias: the PROTECT-AR Study

PROTECT_AR
Start date: July 1, 2019
Phase:
Study type: Observational [Patient Registry]

The purpose of this study is to evaluate the safety and efficacy of apixaban for the prevention of thromboembolism in adult patients with congenital heart disease (CHD) and non-valvular atrial arrhythmias (AA)

NCT ID: NCT03853837 Completed - Heart Failure Clinical Trials

Ventricular and Pulmonary Vascular Reserve After the Fontan Operation

Start date: August 30, 2018
Phase:
Study type: Observational

Aim #1: Define and determine the prevalence of pulmonary vascular disease and diastolic dysfunction as assessed by the gold standard of invasive hemodynamic cardiopulmonary exercise testing. Aim #2: Determine the role of rest-exercise echocardiography for the assessment hemodynamics in Fontan physiology. Aim #3: Evaluate the clinical impact of pulmonary vascular disease and ventricular diastolic dysfunction.