383 Clinical Trials for Various Conditions
The goal of this clinical trial is to learn if a virtually-delivered, group-based psychological intervention, called Tuning in to Kids, is feasible and acceptable for parents of children aged 3 to 6 years with congenital heart disease. The main questions this study aims to answer are: * What do parents of children with congenital heart disease think of the Tuning in to Kids intervention? * Is the intervention helpful for parents? * Is the intervention easy for parents to take part in? * Do the researchers find it easy or difficult to deliver the Tuning in to Kids intervention to parents of children with congenital heart disease? Participants will: * Fill out 3 online surveys at home. * Take part in the Tuning in to Kids intervention (which includes six 90-minute, weekly, online group sessions and two booster sessions) or standard cardiac care. * Take part in an interview.
The Congenital Heart Disease Physical Activity Lifestyle Intervention Study (CHD-PALS) V.2 seeks to determine the efficacy of a lifestyle intervention program for adolescents and young adults (AYAs) with congenital heart disease (CHD). This trial was adapted from the original CHD-PAL trial to continue improving cardiovascular outcomes for transition-aged CHD survivors.
This is a randomized, double-blind, placebo controlled, multicenter study to compare the efficacy and safety of L-citrulline versus placebo in patients undergoing surgery for congenital heart defects. Eligible patients undergoing repair of a large unrestrictive ventricular septal defect (VSD), a partial or complete atrioventricular septal defect (AVSD), or an ostium primum atrial septal defect (primum ASD) will be eligible for enrollment.
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.
This clinical trial is studying the use of different levels of oxygen exposure during and after cardiopulmonary bypass in eligible infants to learn about its safety during heart surgery. In addition to having the various doses of oxygen, participants will also have blood samples, ultrasounds of the head, and brain wave patterns monitored. The hypotheses of this trial are: * that there will be no difference with regards to adverse events between the infants in the normoxia group compared to the infants in the standard of care group * there will be a significant difference in the measured partial pressure of oxygen (PaO2) values between the two treatment groups. * the use of normoxia during cardiopulmonary bypass and in the immediate post-operative period will result in clinically significant decrease in oxidative stress as measured by thiobarbituric acid reactive substances (TBARS) after cardiac surgery
The purpose of the study is to evaluate a peer coaching intervention in young adults with congenital heart disease.
This is a single site, randomized, blinded, sham controlled, parallel group study to identify whether electro-acupuncture (EA) is a beneficial anesthesia adjunct in children undergoing procedures on their congenital heart defects (CHD).
The primary goal of this study is to systematically describe early neurodevelopment using a complementary set of observational and neurophysiological measures that may predict cognitive and motor delays earlier than currently possible for infants with Complex Congenital Heart Disease (CCHD).
Each year, approximately 1 child in every 100 is born with Congenital Heart Disease (CHD), making it the most common birth defect. With recent medical advances, more children with CHD survive early open-heart surgery, so that there are now 2 to 3 million adult survivors with CHD. These survivors face challenges in terms of their cognitive and behavioral development. For many, the limitations affect their academic achievement, social adaption and, ultimately, their quality of life. Among the most disabling limitations are those that pertain to the ability to maintain attention, plan and organize activities, regulate emotions, and develop problem-solving strategies. Collectively, these are referred to as executive functions (EF) because they are higher-order abilities that enable one to coordinate complex behaviors. Additionally, impaired EF also underlie mental health disorders. In spite of the abundance of evidence that children with CHD struggle with EF, there is little to offer them in the way of evidence-based interventions to prevent or mitigate these problems. The investigators propose to conduct the first randomized trial to evaluate the efficacy of an intervention, the Cogmed Working Memory Program, in improving the neurodevelopment outcomes of children with critical CHD after infant open-heart surgery. Children who meet eligibility criteria and who agree to participate will be randomly assigned to an intervention or control group. Children in the intervention group will complete 25 35-40 minute sessions of Cogmed training, spread over for 5 weeks. This Program is a set of home-based, child-friendly, computerized activities. The control group will receive the standard of care for children with CHD. Children's scores on EF and related neurodevelopmental tests will be evaluated before the intervention group completes Cogmed training, at the conclusion of their training, and 3 months later. The latter assessment will indicate whether any gains in EF skills of the children in the intervention group are sustained after training. Parents and teachers will also complete questionnaires about children's EF, attention, and social behaviors to determine whether training affects behaviors of the intervention group at home and in school. The investigators will also identify the medical and surgical characteristics of children who benefit most from Cogmed training. This information will be helpful in targeting the intervention most efficiently in the future.
The purpose of this study is to investigates serum and stool biomarkers as predictors for post-operative feeding intolerance in infant patients with complex congenital heart defects who undergo single ventricle staged palliation surgery.
Infants requiring surgery in the neonatal period for complex congenital heart diseases are at risk for developmental problems. For infants with congenital heart diseases with admixture physiology and single ventricles, optimal circulation is associated with signs of adequate systemic perfusion and a systemic arterial oxygen saturation typically between 75% to 90%. Infants are often unable to withstand standardized developmental testing during early infancy due to medical fragility and sternal precautions after surgery. Evaluation of the quality of spontaneous movements and movement variability is a good alternative. The quality of general movements in early infancy is a valid predictor of neurological disorders in high risk infant groups and is assessed with short periods of video-recorded observations. This methodology has yet to be studied in infants with complex congenital heart disease that require surgery as neonates. For older infants, the Infant Motor Profile (IMP) is a promising tool to document developmental outcome.
The goal of this study is to obtain specimens and data from individuals and their families with heterotaxy and related congenital heart defects in order to clarify the molecular genetics of this disorder. The knowledge gained from the analysis of this information will provide the basis for future genetic counseling as well as contribute to knowledge about the biology of normal and abnormal development of left-right anatomic asymmetry.
The purpose of this study is to examine the differences in perceived health, psychosocial functioning, behavioral outcomes and quality of life of adults with congenital heart disease who are living in different areas of the world, and how these differences can be understood (e.g., differences in sense of coherence or illness perceptions).
Recent advances in genomic techniques are making possible a new wave of genetic discovery in congenital heart disease (CHD). Existing data suggests that CHD occur in Sub-Saharan Africa at frequencies similar to the rest of the world. In this application, we propose to utilize the unique advantages of Sub-Saharan Africa - a combination of the most genetically diverse populations in the world and of diminished environmental background effects (i.e. low prevalence of smoking, alcohol abuse, obesity in comparison to western countries) - to better understand the genetic basis for congenital heart disease. We will couple next generation genomic techniques with more traditional gene discovery methods to investigate CHD in two African countries: Uganda and Nigeria. The inclusion of syndromic and non-syndromic CHD observed in these populations as well as careful phenotyping (including echocardiography) will greatly enhance our potential to provide insight into the genetic architecture of CHD in African populations. To accomplish this, we plan to enroll families, in whom members have congenital heart malformations consistent with an error of early human development in our research protocol. Patients will be enrolled at the Uganda Heart Institute in Kampala, Uganda, and at the Department of Pediatrics, College of Medicine, University of Lagos, Nigeria, with the potential to include other African sites. High throughput genomic studies will be done at the NIH.
Infants with congenital heart disease and increased pulmonary blood flow have altered carnitine homeostasis that is associated with clinical outcomes; and L-carnitine treatment will attenuate these alterations and improve clinical outcomes. The investigators will pilot a trial assessing the safety and pharmacokinetics of perioperative IV L-carnitine administration in these patients. To this end, a pilot clinical trial is proposed. Infants with ventricular septal defects or atrioventricular septal defects undergoing complete surgical repair will receive L-carnitine (25, 50, or 100 mg/kg, IV) just prior to cardiopulmonary bypass (CPB) and 2hr after CPB. Carnitine levels will be measured before CPB, and before and 0.5, 1.5, 3, 5, 9, 12, and 24h after the second dose. The safety, pharmacokinetic profile, feasibility, and effect of L-carnitine administration on biochemical parameters, as well as clinical outcomes will be determined. The investigators expect this pilot to provide the data needed to proceed with a placebo-based randomized, controlled, trial.
The hypothesis of this study is that participation in a formal cardiopulmonary rehabilitation program improves aerobic exercise capacity and quality of life over the medium term for patients with congenital heart disease with reduced exercise capacity. To test this hypothesis, subjects will be randomized to either receive a 12-week cardiopulmonary rehabilitation program or standard of care, with interval testing of aerobic capacity and other physiologic markers improved fitness, as well as assessment of quality of life.
The purpose of this study is to understand how having a heart problem affects development,quality of life, and family life in young children and their families. Results for children and families with heart disease will be compared to children and families without heart disease. The investigators hope that this information may help us to support children and families better in the future. All children and families that are seen in the HHC Developmental Follow-Up Program will be asked if they would like to take part in this study. It is hypothesized that children with congenital heart disease will demonstrate developmental delays when compared to normative values.
The purpose of this research study is to learn about parents' experiences following diagnosis of a fetal/neonatal Congenital Heart Defect (CHD). Nurses, physicians, and other health-care clinicians will benefit from an improved understanding of what the diagnosis means to parents and what they expect concerning the infant, being a parent, and caregiving tasks and responsibilities. The investigators expect that the knowledge gained will increase clinicians' ability to respond to parents' needs.
Postnatal intestinal function in cardiac infants. The overall goal of this proposal is to address a widespread health problem in the pediatric cardiac infant population - poor postnatal growth - through a collaborative effort between pediatric cardiology, cardiothoracic surgery, neonatology, microbiology, and immunology. The hypothesis is that term neonates with complex congenital heart disease (CHD) who receive trophic breastmilk feeds in the pre-operative period will show improved gut function than neonates who were strictly NPO (nothing by mouth) in the pre-operative period.
Congenital heart defects (CHD) are the most common major human birth malformation, affecting \~8 per 1,000 live births. CHD are associated with significant morbidity and mortality, and are second only to infectious diseases in contributing to the infant mortality rate. Current understanding of the etiology of pediatric cardiovascular disorders is limited. The Congenital Heart Disease GEnetic NEtwork Study (CHD GENES) is a multi-center, prospective observational cohort study. Participants will be recruited from the Pediatric Cardiac Genomics Consortium's (PCGC) centers of the NHLBI-sponsored Bench to Bassinet (B2B) Program. Biological specimens will be obtained for genetic analyses, and phenotype data will be collected by interview and from medical records. State-of-the-art genomic technologies will be used to identify common genetic causes of CHD and genetic modifiers of clinical outcome. To accomplish this, the PCGC will develop and maintain a biorepository of specimens (DNA) and genetic data, along with detailed, phenotypic and clinical outcomes data in order to investigate relationships between genetic factors and phenotypic and clinical outcomes in congenital heart disease.
Congenital heart disease (CHD) is the most common type of birth defect but the cause for the majority of cardiac birth defects remains unknown. Numerous epidemiologic studies have demonstrated evidence that genetic factors likely play a contributory, if not causative, role in CHD. While numerous genes have been identified by us and other investigators using traditional genetic approaches, these genes account for a minority of the non-syndromic CHDs. Therefore, we are now utilizing whole genome sequencing (WGS), with the addition of more traditional genetic techniques such as chromosomal microarray or traditional linkage analysis, to identify genetic causes of familial and isolated CHD. With WGS we are able to sequence all of the genetic material of an individual and apply different data analysis techniques based on whether we are analyzing a multiplex family or a cohort of trios (mother, father and child with CHD) with a specific isolated CHD. Therefore, WGS is a robust method for identification of novel genetic causes of CHD which will have important diagnostic and therapeutic consequences for these children.
The purpose of this study is to measure blood levels of TXA in children having cardiac surgery which requires cardiopulmonary bypass. TXA is used to reduce bleeding during surgery. This study will help determine if the current dosing of TXA results in therapeutic blood levels.
Children who are born with heart defects undergo surgery when they are infants to correct the defects. However, many treatments that are used in pediatric heart patients were originally developed for adults and may not be the best option for children. This study will analyze tissue samples from newborns and infants undergoing surgery for heart defects to learn more about how a child's heart develops during the first year of life. This information may help to identify possible treatments geared specifically for the pediatric heart patient.
This study will examine genetic material obtained from blood and tissue samples of patients with congenital heart disease (CHD) and heterotaxy (an abnormality in the left-right positioning of organs in the body, also called situs inversus) to gain a better understanding of these disorders and of a lung disease called primary ciliary dyskinesia (PCD). CHD is prevalent in patients with heterotaxy. It is believed that certain forms of CHD or heterotaxy may have the same genetic origin as PCD. Individuals 2 years of age or older who have a CHD or heterotaxy or both may be eligible for this study. Participants undergo some or all of the following tests and procedures: * Blood tests, electrocardiogram (EGC) and chest x-ray. * Saliva collection: Subjects rinse their mouth with water, and then spit approximately 1.5 cc of saliva into a sterile container. * Buccal swabs: A small soft, toothbrush-like swab is rubbed on the inside lining of the cheek to collect tissue samples. * Nasal tests to measure nasal nitric oxide levels and to obtain tissue samples from the inside of the nostrils: For the nitric oxide level test, a rubber probe is inserted into one of the nostrils until it fits snugly and comfortably. The subject then takes a deep breath and then exhales all the way out through the mouth through a plastic device. During exhalation, gas measurements are recorded on a computer. To obtain tissue samples, a device is inserted in a nostril and scraped gently against the inside of the nose. * Echocardiography: This ultrasound test of the heart uses sound waves to obtain pictures of the heart. A small wand with a warm clear gel is moved around the chest to obtain the images. * Abdominal ultrasound: This ultrasound test of the heart uses sound waves to obtain pictures of the abdominal organs. A small wand with a warm clear gel is moved around the abdomen to obtain the images....
Congenital heart disease is one of the most common malformations in newborns. About 1% of newborns have cardiac malformations. Many need open heart surgery, which contributes substantially to pediatric mortality and morbidity. Recent advances in genetics suggest that many congenital heart defects are caused by mutation of genes. So far, half a dozen genes are found to be associated with congenital heart diseases, such as TBX5, NKX2.5, and GATA4, to name a few. In the near future, more genes will be identified. This study will evaluate the role of mutation of genes in congenital heart diseases and study the genotype-phenotype correlation. The central hypothesis is that a significant percentage of congenital heart disease is caused by mutation of genes involved in heart development, and the phenotype with missensed mutations is milder than nonsense mutation. Another hypothesis is that a significant proportion of patients with cardiac malformations will have mutations in their genes. The specific aim is to test the mutations of these genes in patients with congenital heart diseases. The study will provide substantial information to understand how the human heart develops. In the future, prenatal diagnosis could be developed based on this study.
The purpose of this study is to examine the pharmacokinetics, pharmacodynamics, and pharmacogenomics of dexmedetomidine in the following three pediatric patient populations: patients with bi-directional cavopulmonary anastomosis or a Fontan procedure, patients who have had a cardiac transplant, and patients with otherwise normal physiology who are undergoing closure of a patent ductus arteriosis or atrial septal defect.
Anemia is a common disorder in infants with one working chamber of the heart that pumps blood. Anemia is when the level of healthy blood cells becomes too low. This may cause other health problems because red blood cells contain hemoglobin, which carries oxygen (needed for survival) to different parts of the body. This study will look at the role of iron in preventing anemia in infants with one pumping chamber. The importance of iron therapy will be examined. Hypothesis: Prophylactic use of iron in infants with single ventricle is effective in preventing anemia.
Review the feasibility, safety and outcomes in adults with congenital heart disease who undergo pacemaker implantation for bradycardia, tachycardia or heart failure indications
In today's world of advanced surgery, children born with congenital heart disease (CHD) are surviving into adulthood. However, the surgical procedures these children undergo do not cure the underlying problem and this these children develop other heart problems later in life. Heart failure is the one of the most common heart problems effecting these patients. This heart failure can be seen in both lower pumping chambers of the heart, however, sometimes only one side of the heart is affected. Since there are several congenital heart defects that are now seen in the adult population, an understanding of what causes heart failure in this patient population can help physicians develop better treatments for this condition. The goal of this study is to review the medical records of 350 adult patients with congenital heart disease that has developed heart failure. During this review, we plan to collect information regarding the various treatments utilized in these patients and to determine if there are any common elements regarding the development of heart failure in adult patients with CHD.
Congenital heart disease in infants and children often challenges healthcare providers both in regards to diagnosis and in the management of these conditions. The field becomes more complicated as one examines the myriad of defects that present and the complex care that is required. Over the last 20-25 years, the remarkable advances in the medical and surgical management of the most complex lesions have decreased neonatal mortality, such that many more survive the neonatal period. Therefore, new challenges regarding the continued care of this patient cohort of high-risk infants and children exist. In order to continue the improvement of treatment(s) offered to these patients, continuous review and analysis of the current standard of care is needed. In this study, the investigators will collect information related to the current surgical and medical therapies offered to patients enrolled in the High Risk Congenital Heart Program at Children's Healthcare of Atlanta. All of the procedure and visit information will be a part of the child's standard of care. This information will be placed in a database. The investigators hope to learn more about the short-term and long-term effects of current therapies and procedures.