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Heart Defects, Congenital clinical trials

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NCT ID: NCT01192360 Completed - Asthma Clinical Trials

Dynamic Contrast Enhanced Magnetic Resonance Perfusion Imaging in Congenital Heart Disease and Lung Disease

Start date: September 2010
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to determine if quantitative Dynamic contrast-enhanced magnetic resonance (DCE MR) perfusion imaging accurately quantifies right and left pulmonary artery blood flow as compared with phase contrast flow velocity mapping (PC), the current gold standard of flow volume measurements.

NCT ID: NCT01192048 Recruiting - Clinical trials for Congenital Heart Disease

Genetics of Congenital Heart Disease

Start date: December 2009
Phase:
Study type: Observational

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 only 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.

NCT ID: NCT01189981 Completed - Clinical trials for Congenital Heart Disease

Effect of eHealth Encouragements to Intensive Exercise in Adolescents With Congenital Heart Disease

PReVaiL
Start date: October 2010
Phase: Phase 2
Study type: Interventional

All over the world 0.8 % of all live children are born with a Congenital Heart Disease (CHD) due to genetic end environmental causes. Advanced treatment and care has enhanced survival substantially, and adults with CHD are a growing population requiring continuous monitoring and care. Presently 25% of young adults acquire complicating Cardio Vascular Diseases (CVD) in young adulthood amongst other co-morbidities. It is known that adolescents with CHD are not as physical fit (PF) as their cardiac capability allows, most likely for reasons concerning safety, ability plus inactive everyday life. However, in 2006 The European Society of Cardiology states, that regular exercise at recommended levels can be performed and should be encouraged in all patients with CHD. Training programmes in hospitals have an effect on PF and Quality of Life (QoL) for the few, as most adolescents' find it impossible to fit into everyday life. It is the investigators hypothesis that an eHealth intervention, to facilitate intensive exercise in the patients' neighbourhood environs, may improve physical fitness more efficiently than standard lifestyle education. The purpose of the study is to create evidence to recommend an efficient, fun and safe cardiac rehabilitation programme to adolescents with CHD. Primary outcome measure Cardiopulmonary exercise capacity: Online V02 max bicycle test Secondary outcome measure Level of physical exercise: Actigraph and Questionnaire Tertiary outcome measure Quality of Life: PedsQl Prevail is a national prospective, randomized clinical trial including 216 adolescents aged 13-16 years, who have had cardiac surgery in childhood owing to complex CHD. The patients included are all recommended to be as physical active as their healthy peers and pursue the principle guideline from The National Board of Health: "All children and young people must be physically active for at least 60 minutes a day, preferably longer". Patients with mental retardation and FEV1 at baseline < 80% of predicted are excluded. The risk of participating in the purposed trial is not regarded as higher than everyday daily living. Results will be interpreted according to affiliation to health related fitness clusters.

NCT ID: NCT01184404 Recruiting - Clinical trials for Congenital Heart Disease

Bosentan Improves Clinical Outcome of Adults With Congenital Heart Disease or Mitral Valve Lesions Who Undergo CArdiac Surgery

BOCA
Start date: September 2011
Phase: N/A
Study type: Interventional

Cardiac surgery relieves symptoms and increases life expectancy in cardiac patients, with and without congenital heart disease (CHD). However, cardiac surgery involves many risks of complications, such as bleeding, arrhythmias, and death.Right ventricular failure is another complication, contributing to poor clinical outcome. Right ventricular failure is a clinical syndrome, often difficult to treat, characterized by edema, elevated jugular venous pressure, oliguria, hypotension, and in severe cases shock, multi organ failure and death. Patients with CHD and patients with mitral valve lesions are suspected to be at increased risk for developing right ventricular failure post-operatively. In addition, other clinical factors contributing to right ventricular failure are mechanical pulmonary ventilation, pulmonary hypertension and cardiac surgery. Right ventricular failure during cardiac surgery is caused by the cardiopulmonary bypass by reperfusion with high partial pressures of oxygen, air embolism, and the release of cytokines. The endothelin-1 cytokine induces vasoconstriction of the pulmonary arterioles resulting in right ventricular afterload elevation. Treating patients with an endothelin-1 receptor antagonist might improve clinical outcome post operatively by decreasing right ventricular afterload

NCT ID: NCT01178710 Completed - Clinical trials for Congenital Heart Disease

Effect of Simvastatin on Cardiac Function

Start date: September 2010
Phase: N/A
Study type: Interventional

It is well know that statins have been used to low cholesterol to prevent and treat coronary artery disease for many years. It was also reported that statins could protect endothelial function and cardiac function during coronary artery bypass graft. However, some results were controversial. Also, there is no clinical data available on statin cardiac protection during surgery in China where rheumatic heart disease is prevalent. Thus, the investigators are trying to see whether statins can protect heart injury during cardiac surgery in Chinese. Part of patients will receive statin treatment and part of will not before surgery in the study. Both patients' heart function will be measured and compared after surgery to determine whether statins can protect heart injury during heart surgery.

NCT ID: NCT01134302 Recruiting - Clinical trials for Congenital Heart Disease

Hybrid Versus Norwood Management Strategies in Infants Undergoing Single Ventricle Palliation

Start date: March 2010
Phase: Phase 3
Study type: Interventional

The purpose of this trial is to determine, at 3 years of life, how the neurologic and functional outcomes in infants with single ventricles are different when comparing children treated with the Hybrid strategy to the Norwood strategy.

NCT ID: NCT01126372 Completed - Clinical trials for Congenital Heart Disease

Prediction of Feeding Problems in Prostaglandin-dependent Prematurely Born Infants With Congenital Heart Disease

Start date: May 2010
Phase: N/A
Study type: Observational

Prematurely born infants with ductal-dependent congenital heart disease (CHD) are at increased risk to develop necrotizing enterocolitis (NEC). Abnormal left to right blood flow through a patent ductus arteriosus can cause intestinal ischemia and compromise the gastrointestinal tract as a barrier to infection. In some infants, bacterial translocation leads to NEC which may result in death, intestinal perforation, cholestasis and, at the very least, feeding problems. Predicting which infants with CHD will develop NEC will potentially decrease the severity of disease if interventions were started earlier. Near-infrared spectroscopy (NIRS) allows determination of regional oxygen saturation levels in tissues such as brain, kidney, and as recently reported, intestine. This study will test whether or not decreasing intestinal oxygen saturations can predict the development of NEC in this at risk population before the symptoms become severe. NIRS probes will be placed on the forehead, flank and abdomen of eligible infants and regional oxygen saturations will be recorded prospectively and continuously with the clinical care team blinded to the data. The development of NEC and significant feeding problems will then be correlated with the regional oxygen saturations to determine whether decreased intestinal oxygen saturations predicted early signs and symptoms of NEC. We anticipate generating pilot data in 30 infants who meet inclusion criteria. Support of this research will be provided partially by Somanetics, the manufacturer of the INVOS regional oxygen saturation monitors. They will, however, have no control over the data generated by this study.

NCT ID: NCT01082536 Withdrawn - Clinical trials for Congenital Heart Disease

Analysis of Cerebral Perfusion Using Head Ultrasound and Multisource Detector Near Infrared Spectroscopy (NIRS) Imaging

Start date: March 28, 2013
Phase:
Study type: Observational

The purpose of this study is to use an experimental diagnostic tool(NIRS), combined with a known screening tool (cranial ultrasound), to analyze and evaluate cerebral blood flow and oxygenation, and determine if abnormal neurodevelopmental outcomes can be predicted and potentially improved upon in pediatric patients undergoing repair for congenital heart disease.

NCT ID: NCT01075178 Completed - Clinical trials for Severe Respiratory Syncytial Virus Infection

Retrospective Palivizumab Study in Children With Hemodynamically Significant Congenital Heart Disease

Start date: July 2006
Phase: N/A
Study type: Observational

Retrospective medical record review study of specific adverse events in children with congenital heart disease who received palivizumab for prophylaxis of serious respiratory syncytial virus infection and control subjects that did not receive palivizumab

NCT ID: NCT01069510 Completed - Heart Failure Clinical Trials

Spironolactone in Adult Congenital Heart Disease

Start date: February 2010
Phase: Phase 2
Study type: Interventional

The purpose of this study is to see if the study drug called spironolactone reduces fibrous (stiffening) in heart muscle tissue and improves heart function. Subjects from the study titled "Heart Failure in Congenital Heart Disease: the role of myocardial fibrosis" who have evidence of heart dysfunction and/or evidence of fibrosis (stiffening) in the heart muscle will be asked to take part in this study.