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Pediatric Heart Disease Clinical Research Network Clinical Trials Data presented on Clinical Trials Search isn't meant to be a substitute for qualified health advice, calls or treatment using a genuine doctor. We are not docs. Always consult your dr. on Pediatric Heart Disease Clinical Research Network conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Pediatric Heart Disease Clinical Research Network Clinical research trials and Pediatric Heart Disease Clinical Research Network healthcare trials occur in a lot of of places throughout the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the potency of new drugs. The intent of the studies / undertakings is to figure out certain human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector corporations to locate remedies for all kinds of circumstances, including Pediatric Heart Disease Clinical Research Network. Pediatric Heart Disease Clinical Research Network Clinical Trials and other clinical trials allow volunteers to obtain health treatment alternatives before they are available to the masses. Many times the participants undergo treatment for free, and sometimes they are paid for their time. Occasionally there is a cost for a Pediatric Heart Disease Clinical Research Network clinical trial. Participants typically obtain the most effective healthcare available for their Pediatric Heart Disease Clinical Research Network condition. Dangers are a reality, nonetheless, and can include extra or frequent mD trips, medical hazards (potentially life-endangering), and/or the treatment being uneffective. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
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Home > "P" Clinical Trials Conditions > Pediatric Heart Disease Clinical Research Network  Pediatric Heart Disease Clinical Research Network
Pediatric Heart Disease Clinical Research Network
For Condition: Arrhythmia,Pediatric Heart Disease,Defect, Congenital Heart,Kawasaki Disease
Status: Recruiting
Sponsor(s): National Heart, Lung, and Blood Institute (NHLBI) ,
Synopsis: To evaluate novel treatment methods and management strategies to benefit children with structural congenital heart disease, inflammatory heart disease, heart muscle diseases, and arrhythmia.
Details: BACKGROUND: Approximately 32,000 infants are born each year in the United States with congenital cardiovascular malformations, the most common congenital anomaly, and one of the leading causes of infant mortality. The incidence of congenital heart disease is at least triple that of childhood cancers, and substantially greater than pediatric AIDS. A significant number of additional children experience medical problems from inflammatory cardiac conditions, heart muscle disease, and arrhythmias. Affected children experience morbidity and mortality that generate health and economic consequences out of proportion to their numbers. In spite of recent improvement, the mortality rate for structural congenital malformations varies from less than 1 percent to as high as 50 percent, depending on the condition. The medical, social and economic consequences of pediatric heart disease are profound, and include frequent medical monitoring and the need for invasive procedures, high medical care expenses, disruption of family life, the high cost of potential productive years of life lost when a child dies, and loss of parental productivity and wages. Treatment of congenital and acquired pediatric heart disease involves medical, surgical, and catheter-based approaches. Great strides have been made in diagnosing and treating pediatric heart disease since 1944, when the first operation for palliation of tetralogy of Fallot was performed, but important clinical questions remain unanswered. Medical therapy is employed widely to treat various pediatric heart diseases including arrhythmias, heart failure, myocarditis, and coronary artery aneurysms arising after Kawasaki Disease. Few drugs used as "standard therapy", however, have been tested in randomized controlled trials in pediatrics. For example, standard pharmacological agents used in the treatment of adult heart failure, such as diuretics, digitalis, angiotensin-converting enzyme (ACE) inhibitors, and beta-blockers, are used in children, but have not been studied in a systematic fashion. Emerging adult therapies, such as immune modulation in heart failure, may benefit children but are virtually untested in pediatric populations. In addition, pediatric heart failure can arise from multiple causes, including structural heart defects, heart muscle disease and inflammation, post-operative injury and edema, and poorly-controlled arrhythmias. Standard and novel pharmacological agents may have different effects in specific types of heart failure. As another example, immunosuppressive therapy, commonly used to treat pediatric myocarditis, has never been evaluated in a prospective, randomized trial. Many structural congenital heart abnormalities are successfully corrected surgically. However, the optimal timing and approach for complex congenital structural malformations including the several malformations that lead to single ventricle physiology are not known, and the risks and benefits of devices compared to surgical repair of certain defects have not been studied systematically. In addition, the acute and chronic post-operative course can be complicated by conditions such as post-cardiopulmonary bypass syndrome (especially in infants), arrhythmias including those implicated in sudden death, neurodevelopmental deficits, ventricular dysfunction and heart failure, and coagulapthy leading to the need for reoperation. Treatment strategies for these conditions are not supported by systematic prospective clinical studies. A prime example is sudden cardiac death associated with repair of complex cyanotic congenital heart disease. Many of these survivors are adolescents who have arrhythmias that may not be clinically apparent, and may require invasive testing to discern. However, the correlation between results from invasive testing and sudden death is not clear, so it is difficult to risk-stratify surgical survivors for implantable defibrillator placement. As the number of such survivors grows, there is increased urgency to answer this question. Like heart failure, pediatric arrhythmias can occur in several settings, such as abnormal electrical pathways in structurally normal and abnormal hearts, postoperative edema and injury, inflammatory and heart muscle conditions, and ventricular dysfunction. Therapeutic approaches include medical, interventional, and surgical strategies, which have improved the care of affected children. As with other pediatric heart conditions, however, important treatment questions remain. Most treatment decisions concerning these and other pediatric heart disease are not evidence-based. In the past 25 years, fewer than 40 randomized clinical trials have been conducted, of which nearly half dealt with patent ductus arteriosus in preterm infants. The major barriers to clinical studies in pediatric heart disease include the heterogeneity of conditions, the small numbers of individuals with a particular malformation or condition at any one center, differences in treatment approaches to particular problems, the absence of systematic centralized databases, and the lack of resources to provide national coordination of collaborative efforts. The network approach is an effective, flexible way to study adequate numbers of patients with uncommon diseases, such as congenital cardiovascular malformations. Efficiencies will be achieved through a common infrastructure for recruiting, monitoring, and following patients whose conditions will be characterized in a standard fashion. A network also can serve as a platform to train junior investigators in pediatric clinical research, and as a vehicle for rapid and wide-spread dissemination of findings. A collaborative effort through a clinical research network is the most scientifically sound and cost-effective way to overcome the current barriers and provide the information needed to bring evidence-based medicine to bear on children with heart disease. The Request for Applications was issued in May, 2000. DESIGN NARRATIVE: The network will establish and maintain the infrastructure for a data coordinating center amd multiple clinical centers to conduct multiple clinical trials. Protocols under development include: Biventricular Pacing for Children with Dilated Cardiomyopathy and Heart Failure; Acetylcholinesterase (ACE) Inhibition in the Treatment of Mitral Valve Regurgitation After Repair of Complete Atrioventricular Canal Defects. Three recently developed and approved protocols have begun recruitment. They include: Trial of Pulse Steroid Therapy for Kawasaki Disease; The Relationship Between Functional Health Status and Laboratory Parameters of Ventricular Performance After the Fontan Procedure; and ACE Inhibition in Infants with Single Ventricle.
Eligibility:
Study Type: Interventional, Diagnostic, Randomized
Minimum Age/Maximum Age: /21 Years
Genders: Both
Protocol Entry Criteria: Varies with protocol
Total Enrollment:
Location and Contact Information:
Overall Study Official:
JaneNewburger, , Children's Hospital Boston
Children's Hospital of Philadelphia *Recruiting*
Philadelphia, Pennsylvania, 191104-439
United States
Recruiting Victoria Vetter 215-590-3546
Primary Children's Medical Center *Recruiting*
Salt Lake City, Utah, 84113
United States
Recruiting LuAnn Minich 801-588-2600
Hospital for Sick Children *Recruiting*
Toronto, Ontario, M5G 1X8
Canada
Recruiting Brian McCrindle 416-813-7609
Columbia Presbyterian Medical Center *Recruiting*
New York City, New York, 10024
United States
Recruiting Daphne Hsu 212-305-6575
Medical University of South Carolina *Recruiting*
Charleston, South Carolina, 29425
United States
Recruiting J. Saul 843-792-3287
Duke University Medical Center *Recruiting*
Durham, North Carolina,
United States
Recruiting Page Anderson 919-684-6027
Children's Hospital of Boston *Recruiting*
Boston, Massachusetts, 02115
United States
Recruiting Jane Newburger 617-355-5427
Additional Information:
Study ID Numbers: 138;
Study Start Date: September 2001
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00023517
Other Arrhythmia Studies:
1. Pediatric Heart Disease Clinical Research Network
Related Studies:
Other Arrhythmia Clinical Trials
Other Massachusetts Clinical Trials
Other Boston Clinical Trials
Pediatric Heart Disease Clinical Research Network
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