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106 active trials for Congenital Heart Disease

A 10-Minute Cardiovascular Magnetic Resonance Protocol for Cardiac Disease

This study aims to identify and assess new CMR techniques that can improve current CMR protocols.

Start: December 2019

Pulmonary Capillary Recruitment in Fontan Patients

This study evaluates the effects of pulmonary vasodilator therapy on pulmonary capillary blood flow by measuring the functional capillary surface area (FCSA) at baseline and post nitric oxide inhalation, through the injection of 3H-benzoyl-Phe-Ala-Pro (BPAP). FCSA will be related to flow and other hemodynamic parameters in order to determine if there is capillary recruitment or distention in Fontan patients. We will also compare baseline FCSA measurements with previously studied normal subjects, to assess the difference in hemodynamic pulmonary functional parameters between these single ventricle physiology patients and normal subjects.

Start: June 2020

Image-based Multi-scale Modeling Framework of the Cardiopulmonary System: Longitudinal Calibration and Assessment of Therapies in Pediatric Pulmonary Hypertension

This study looks to develop a multi-scale computational model of Pulmonary Hypertension, this clinical model will be calibrated using longitudinal, retrospectively and prospectively acquired human clinical data.

Start: April 2017

Acute Kidney Injury After Cardiac Surgery on CPB

The purpose of this retrospective study is to determine the incidence and severity of acute kidney injuries (AKI) after heart surgery on cardiopulmonary bypass (CPB) in the pediatric intensive care unit (PICU) in Lausanne, Switzerland.

Start: October 2017

Enhanced Physical Activity Support in Congenital Heart Disease Clinical Care

Our cluster randomized controlled trial of a novel clinical practice change will IMPACT the physical activity (PA) of children living with congenital heart defects (CHD) through our Innovative and pragmatic approach to systematically incorporate PA counselling within each clinic visit. Long-term, the focus is to prevent or treat the most common secondary morbidities of these patients (atherosclerosis, anxiety, depression) through enhanced PA. We have previously shown that home-based, PA interventions can increase daily PA and enhance PA motivation, motor skill and fitness when delivered via an intensive research intervention. Our objectives for this study are to Measure the feasibility and efficacy of PA counselling using clinical resources among paediatric CHD patients (daily PA, PA motivation, competence, quality of life) and on clinic systems (% patients counselled, clinic/kinesiology personnel support required, clinic visit time, # of PA questions). Our Patient-empowering, ready-to-use, self-explanatory "tool kit" of clinician PA resources and patient/family/clinician friendly searchable electronic PA database will be used to promote the Active lifestyles that are critically important to physical/mental health, peer socialization & childhood growth/development. 90% of children are not active enough for optimal health. We initially target children with CHD because they are less active than peers, and their most important secondary morbidities can be prevented or treated through PA. Our Collaborative approach with patients, their families and leaders in paediatric cardiac healthcare will optimize our "PA tool kit" and novel practice change for Translation to all paediatric CHD healthcare systems (primary, secondary, tertiary) through our pan-Canadian Cardiac Kids Quality of LIFFE Research and Knowledge Exchange Network, a collaborative of 10 patient/family support networks and 10 paediatric cardiac clinics in 6 provinces focused on Learning, Independence, Friends, Fitness & Emotional health (LIFFE).

Start: March 2018

Erythropoietin to Prevent Unnecessary Transfusions In Patients With Cyanotic CHD - A Prospective Control Trial

Cyanotic congenital cardiac patients require higher hemoglobin concentrations (red blood cell levels) for optimal oxygen delivery to the body. Prophylactic erythropoietin (EPO) and iron can prevent and/or decrease the amount of blood transfusions needed in this population. We seek to investigate if EPO and iron make a clinically significant difference in the number of transfusions given to these patients and the morbidity associated with it.

Start: November 2016

Evaluation of Web-based Transition Education to Enhance Transition Readiness

The study looks to learn more about the helpfulness of web-based transition education and its effect on transition readiness and health service utilization in the adolescent and young adult congenital heart disease population.

Start: August 2018

Fontan Imaging Biomarkers (FIB) Study

The goal of the Fontan Imaging Biomarkers (FIB) study is to identify the associations of blood and urine biomarkers to imaging parameters of ventricular mechanics.

Start: September 2015

Genetic Determinants of Congenital Heart Disease Outcomes

The purpose of this study is to examine the role of genetic variation in the oxidative stress response on critical perioperative and short-term outcomes after neonatal heart surgery. The goals will be to determine 1) if the oxidative stress pathway is an important one for therapeutic intervention in neonates with severe congenital heart defects and 2) if variants in the oxidative response pathway can be used to identify patients at increased risk for adverse outcomes.

Start: March 2011

Clinical Characteristics and Associations of the "Good Fontan" Patient

This study aims to determine what are some of the clinical characteristics and associations of Fontan patients who are doing well, as well as how accurate cardiology providers are at predicting the likelihood of future adverse event in their Fontan patients.

Start: March 2018

Thiamine Influenced on Substrate Energy Effectiveness in Indonesian Children Undergoing Cardiopulmonary Bypass

This is a randomized, double-blind, controlled trial design. It was conducted with a main purpose of evaluating the effect of thiamine supplementation on serum lactate and lactate-pyruvate ratio after surgery as direct indicators of tissue perfusion and indirect markers of energy substrate availability for effective mitochondrial function and intubation time as clinical outcome.

Start: July 2018

The Effect of Fluids Flushed in Pediatric Cardiac Catheterization Procedures on Lung Ultrasound Score

Therapeutic catheterizations substituted many traditional surgical procedures with the advance of transcatheter techniques. Pediatric patients are more liable to fluid overload due to their smaller weights compared to adults and the risk increases in pediatrics with congenital heart diseases due to lower tolerability and reserve capacity and some of them may already have a degree of heart failure. Fluid overload increases the incidence of morbidity and mortality in such patients. The aim of our study is to observe the amount of fluids needed for flushing during pediatric cardiac catheterization (in ml/kg) and asses its effect on total lung water and PaO2/FiO2, aiming to develop a useful protocol for the amount of fluids used.

Start: March 2020

Procedural Outcomes of Percutaneous PDA Closure: Comparative Study Between Different Devices.

To compare safety, efficacy and procedural outcome of percutaneous PDA closure using different approaches for better characterization of device selection criteria.

Start: June 2020

Transverse Thoracic Plane Block in the Pediatric Cardiac Patient

Postoperative pain after cardiothoracic surgery can be a significant problem interfering with recovery, yet difficult to manage due to the sedating effects of opiates. These patients frequently have associated postoperative pulmonary changes and are at risk of respiratory depression with opioid analgesia. The ultrasound-guided transversus thoracic muscle plane block (TTMPB) is a recently described regional anesthetic technique showing improvements in postoperative pain management. Further investigation is needed to establish the potential of the TTMPB as an analgesic modality in congenital cardiothoracic surgery in patients under the age of 18.

Start: January 2018

MRI and Computational Simulation Cardiology Study

The purpose of this study is to (1) quantify cardiovascular anatomy and physiology using magnetic resonance imaging under both resting and exercise conditions in patients who have congenital heart disease and in age-matched normal volunteers, (2) use computer models to reproduce and simulate blood flow in these patients, and then (3) to combine the imaging data and computer models to estimate values which cannot be directly measured and to predict physiological changes induced by exercise and medical or surgical therapies.

Start: February 2008

Clinical Audit On Management Of Congenital Heart Disease In ACUH

Congenital Heart Disease (CHD) is the most common birth defect in the United States, affecting approximately 0.8% of live births. Improved treatment strategies and interventions have increased survival such that 85% to 90% of affected children are expected to live well into adulthood, thereby causing a demographic shift in which adults now outnumber children with CHD, and more people with complex CHD are living longer.

Start: March 2020

Peri-operative Nutrition in Infants With Congenital Heart Disease

The purpose of our multi-center cohort study is to build a large platform to follow up the peri-operative nutrition of children with congenital heart disease. And data will be collected pre and 1, 3, 6, 12 months post surgery including physical, laboratory, imaging examination and questionnaire. The primary outcome is nutrition status (measured as WAZ, WHZ and HAZ) and secondary outcomes were the biochemical index and quality of life.

Start: July 2018

A Comparative Study of Three Modes of Ventilation During CPB in Pediatrics With Pulmonary Hypertension Undergoing Congenital Heart Surgeries

Aim of Work: The aim of this randomized, double-blinded, study is to compare between three modes of ventilation during cardiopulmonary bypass in pediatric patients with pulmonary hypertension undergoing corrective cardiac surgeries. Hypothesis: The hypothesis of the present study is that high frequency low volume positive pressure ventilation is better than continous positive airway pressure (CPAP)and passive deflation on direct PAP (pulmonary artery pressure ) reading and immediate oxygenation after cardiopulmonary bypass CPB in pediatric patients undergoing cardiac surgeries for congenital heart defects.

Start: August 2019

Use of Oxandrolone to Promote Growth in Infants With HLHS

The primary aim of this study is to determine if clinically relevant doses of buccally administered oxandrolone are safe and tolerable in neonates with hypoplastic left heart syndrome (HLHS) or other single right ventricular anomalies who have undergone a Norwood procedure. The secondary aim is to evaluate the efficacy of buccally administered oxandrolone in improving objective indices of growth and nutrition in neonates who have undergone a Norwood procedure.

Start: December 2019

Altered Cerebral Growth and Development in Infants With Congenital Heart Disease

Background: Congenital heart disease (CHD) is the most frequent inborn defect with an incidence of 1 in 100 newborns per year, i.e. 800 children born in Switzerland per year. 10% to 15% of cases are born with single ventricle (SV), the most complex type of CHF requiring immediate surgical intervention after birth. Infants with SV CHD are treated in three surgical staged procedures over the first three years of life. However, cerebral injuries occur in around 40% of those children and impact neurocognitive abilities. As more than 90% of all infants with CHD survive to adulthood, scientific concern is focussed on patient-individual course brain growth and development within the relative contribution of fetal, perinatal, cardiac and surgical risk factors. Therefore, serial cerebral MRI examinations are needed, starting (1) at the third trimester during fetal life proceeding to (2) pre- and postoperative time points at the stage I surgery after birth and (3) before stage II surgery at 4 months of age. We will compare the cerebral MRI findings with a healthy control population, recruited at the same time points, and correlate brain growth and development with the neurodevelopmental outcome assessed at one year of age. Three Pediatric Heart Centers in Switzerland and Germany will participate. The overall aims are: To analyse the patient-individual cerebral developmental trajectories, brain growth and determine the time course of brain abnormalities in infants with single ventricle CHD by serial cerebral MRI during fetal life, after birth and at an age of 4 months (primary endpoints). To determine the neurodevelopmental outcome at one year of age using the Bayley III and will be correlated with the brain growth and brain development in the third trimester of fetal life and at the age of 4 months (secondary endpoints). To analyse fetal, neonatal, surgery-related and intensive care associated factors determining the patient-individual course for altered cerebral growth and impaired neurodevelopmental outcome at one year of age. Methodology: We will prospectively enroll fetuses and neonates with single ventricle CHD at the three Pediatric Heart Centers in Switzerland (Zurich, Bern) and Germany (Giessen). Advanced MR imaging will assess cerebral volumes, microstructural and hemodynamic changes at repeated time points during the third trimester of fetal life (32. week of gestation), the perioperative neonatal period before and after stage I surgery and before stage II surgery at 4 months of age. Biomechanical analysis of longitudinal changes of brain morphology will be applied to longitudinal fetal and neonatal MRI data. Outcome is determined with the Bayley-III at one year of age. Significance: Using a population-based sample of children with single ventricle CHD, we will be able to determine cerebral growth from the third fetal trimester until the first 4 months after birth, when the brain is most rapidly growing. By performing serial brain imaging, the knowledge of etiological pattern affecting cerebral growth, development and brain injury will increase. Morphometric and biomechanical analysis of brain growth patterns will be performed that may capture fine-grained changes associated with CHD. By correlating these data with the neurodevelopmental outcome at one year of age it will be possible to identify specific risk constellations leading to impaired brain development and categories of brain injuries that confer a higher risk of adverse outcome. The better understanding of the pathophysiological mechanisms will serve as the basis for neuroprotective studies and pharmacological trials aiming to improve outcomes in children with CHD in the future.

Start: January 2020