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Heart Defects, Congenital clinical trials

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NCT ID: NCT04815577 Completed - Clinical trials for Congenital Heart Disease

Evolution of Cardiopulmonary Fitness in Children With Congenital Heart Disease

Follow-Heart
Start date: March 1, 2020
Phase:
Study type: Observational

With an incidence of 0.8 %, congenital heart disease (CHD) is the leading cause of congenital anomalies at birth. Medical advances in CHD have transferred the mortality from childhood to adulthood and today there are more adults with CHD than children. After focusing on survival, more attention is being given to health-related quality of life and secondary prevention in this population where warning signals are launched on the risk of sedentary lifestyle, obesity, cardiovascular risk 1. The cardiopulmonary exercise test (CPET), which is a non-invasive and dynamic examination, is becoming the gold standard to the follow-up 2 of these patients by allowing to quantify disease severity, to evaluate the quality of life 3, to give important prognostic information on functional capacity and haemodynamic response 4, to facilitate a safe decision-making when prescribing exercise programmes and sport participation for these children with CHD 5. In this context, in a cross-sectional study from 2010 to 2015, the investigators evaluated the cardiopulmonary fitness of children with CHD by comparing them with healthy children 6. In this study, 496 children with CHD compared to 302 healthy children were included. It showed that maximum oxygen uptake (VO2max) and ventilatory anaerobic threshold (VAT) are decreased in CHD children compared to healthy children, clinical determinants of decreased VO2max have been defined for CHD children. This study was proposed, despite the cross-sectional nature, an average decrease in annual VO2max (0,84 ml/kg/min per year) to make pediatric and congenital cardiologist aware of the need to a regular follow up for these patients. In this new study, the main objective was to know the real evolution of VO2max in these patients from this same cohort, with a longitudinal design, by collecting a new CPET carried out between 2015 and 2020 and compared these results to healthy pediatric population. The secondary objectives were: to know the evolution of the VAT, to define the clinical determinants in relation to the annual decrease of the VO2max. And to describe the population lost to follow-up in this retrospective study which represents current practice.

NCT ID: NCT04814888 Completed - Clinical trials for Congenital Heart Disease

3D Airway Model for Pediatric Patients

Start date: September 3, 2019
Phase:
Study type: Observational

To determine the correct size of endotracheal tubes (ETT) for endotracheal intubation of pediatric patients is no menial task. Although new methods have been investigated to determine ETT size, and the three-dimensional (3D) printing technology has been successful in the field of surgery, there are not many studies in the field of anesthesia. The purpose of this study is to evaluate the accuracy of a 3D airway model for prediction of the correct ETT size, and compare the results with a conventional age-based formula in pediatric patients. : Thirty five pediatric patients under 6 years of age who were scheduled for congenital heart surgery. In the pre-anaesthetic period, the patient's computed tomography (CT) images were converted to STL files using the 3D conversion program. An FDM type 3D printer was used to print 3D airway models from the sub-glottis to the upper carina. ETT size was selected by inserting various sized cuffed-ETTs to a printed 3D airway model.

NCT ID: NCT04812210 Completed - Clinical trials for Congenital Heart Disease

Quality of Life and Neurodevelopment Assessment of Children With Congenital Heart Disease Aged 2 to 4 Years

QoLCHD
Start date: April 1, 2021
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. Nowadays, health-related quality of life (HRQoL) assessment of this population is in the foreground. Our team is a tertiary care center for management of patients with CHD, from the fetal period to adulthood. The investigators have been conducting a clinical research program on HRQoL in pediatric and CHD. The investigators thus demonstrated the link between cardiopulmonary fitness and HRQoL in children with CHD aged 8 to 18 years, the correlation between functional class and HRQoL in adults with CHD, the impact of therapeutic education on HRQoL in children under anticoagulants and the lack of difference between the HRQoL of children CHD aged 5 to 7 years old and that of control children. Currently, no controlled cross-sectional quality of life study assessment has been leded in the youngest children with CHD. This present study therefore extends our work in younger children aged 2 to 4 years.

NCT ID: NCT04810013 Completed - Clinical trials for Complex Congenital Heart Disease

Noninvasive Measurement of the Cerebral Autoregulation in Neonates and Infants With Complex Congenital Heart Disease

Start date: June 1, 2020
Phase:
Study type: Observational

Feasibility of non-invasive cerebral autoregulation measurement at the PICU and impact of changes in oxygen supply

NCT ID: NCT04801251 Not yet recruiting - Clinical trials for Congenital Heart Disease

Red Flags for Cardiac Examination for Early Detection of Congenital Heart Disease

Start date: October 20, 2021
Phase: N/A
Study type: Interventional

The study done to identify the relation between the presence of abnormal clinical cardiac findings and the echocardiographic findings in newborn infants.

NCT ID: NCT04795076 Completed - Clinical trials for Congenital Heart Disease

Effect of Feeding With Nutrient Dense Formula in Malnourished Infants and Children With Congenital Heart Defects

Start date: April 3, 2021
Phase: N/A
Study type: Interventional

Infants with congenital heart disease (CHD) are usually born with a normal weight but develop malnutrition over time, and about 20-50% of these children are usually malnourished. Malnutrition in these patients is multifactorial. To compensate for the increased need for infants and children with CHD, an increase in their caloric intake has been suggested. However, these patients may not be able to receive enough to meet the increased needs and catch-up growth. One of the suggested solutions in these patients to compensate for inadequate food intake is to increase the caloric density of milk or formula. For this purpose, the use of special formulas with higher calorie density or enrichment of normal formula or breast milk using special enrichment formula could be suggested. In the present study, the effect of increasing calorie intake by increasing the concentration of normal formula in comparison with formula with standard concentration on weight gain and other anthropometric indices of CHD patients with malnutrition will be compared.

NCT ID: NCT04787705 Active, not recruiting - Cardiac Surgery Clinical Trials

Multicenter Validation of a Predictor Model of ACHD Patients and Cardiac Surgery

Start date: March 10, 2020
Phase:
Study type: Observational

This multicentre study is to validate prediction modeling for the ACHD population undergoing cardiac surgery. The validation of this prediction model will support and generalize its use as a risk stratification tool in the ACHD population.

NCT ID: NCT04769167 Active, not recruiting - Clinical trials for Diabetes Mellitus, Type 2

Congenital Heart Anomaly Risk in Maternal Enteroviral Infection and Diabetes

CHARMED
Start date: February 1, 2021
Phase: N/A
Study type: Interventional

Beyond EV-B, there are clinical observations to implicate other viruses in birth defects, including CHD. Since the Rubella epidemic of 1960s', however, viruses have received little attention and certainly no comprehensive study, especially using next generation sequencing (NGS), has been undertaken in this context. The current pandemic as well as those caused by Zika, influenza, Ebola and Lassa Fever (among many) have shown pregnant women and their baby are at high risk. Therefore, an open-minded approach is warranted when considering the role of maternal viral infections in CHD. Even less is known about maternal immune response, such as antibody production, to these viruses. The investigator's goal is to answer the above gaps in knowledge. The investigators propose to do that using two different approaches; one retrospective (analysis of samples in two existing, large biorepositories) and the other prospective. The investigator's have created a multi-disciplinary team to bring together the needed expertise from individuals who have overlapping and vested interest in this project. The investigator's specific aim is to examine the diversity of the gut virome in non-pregnant and pregnant women with and without diabetes, with special emphasis on known cardiotropic viruses (those with tropism for cardiac tissues). This study is seen by the investigator's as the first step prior to a larger prospective multi-institutional study to specifically assess the linkage between the maternal virome and CHD pathogenesis.

NCT ID: NCT04768634 Terminated - Clinical trials for Congenital Heart Disease

Predicting Arrhythmogenic Risk in Congenital Heart Patients: the PRECISION Study

Start date: March 23, 2021
Phase: N/A
Study type: Interventional

In this research study we want to learn more about abnormal heart rhythm after cardiac surgery in children. These abnormal heart rhythms, also called arrhythmias, may occur due to several reasons after cardiac surgery. They can be due to abnormal electrical pathway or an irritable area of the heart that stimulates abnormal impulses. Regardless of the cause, arrhythmias after cardiac surgery can be a problem, extending the hospital stay, requiring additional medications and even leading to cardiac arrest. Current practice is to monitor for arrhythmias after cardiac surgery, and to treat them if they occur. With this research, we want to investigate whether we can identify patients who will develop arrhythmia, and treat them before they occur.

NCT ID: NCT04764305 Recruiting - Liver Diseases Clinical Trials

Liver Disease, Myocardial Fibrosis and Collaterals in the Adult Fontan Patient a Metabolomics and Proteomics Approach

Start date: April 1, 2022
Phase:
Study type: Observational

Out objective is to identify the mechanisms that promote hepatic and myocardial fibrosis, and collateral vessel formation in patients with complex congenital heart disease and Fontan circulation.