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Congenital Heart Disease clinical trials

View clinical trials related to Congenital Heart Disease.

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NCT ID: NCT02825472 Recruiting - Clinical trials for Congenital Heart Disease

Exercise Training in Grown-up Congenital Heart Disease

ExTra-GUCH
Start date: February 2016
Phase: N/A
Study type: Interventional

Rationale: Regular physical activity and aerobic exercise training are related to decreased cardiovascular mortality in healthy individuals, as well as in individuals with cardiovascular risk factors and cardiac patients. Unfortunately, no such data is available on exercise training in adult patients with congenital heart disease. Objective: The objective of the ExTra GUCH trial is to assess whether encouragement of a six-month sports participation program in addition to usual care in symptomatic adult patients with congenital heart disease improves exercise capacity and quality of life, and lowers serum N-terminal prohormone brain natriuretic peptide (NT-proBNP) levels. Study design: International, multi-centre parallel randomized controlled trial. Study population: Adult patients with congenital heart disease, who are in New York Heart Association (NYHA) class II or III. Intervention (if applicable): The intervention group receives a six-month individualized exercise training program, the control group receives usual care. Main study parameters/endpoints: The primary outcome is the change in peakVO2 between patients in the sports participation group, and the control group. Secondary outcome measures are change in NYHA functional class, quality of life, and NT-proBNP levels. The primary safety outcome is the composite of all hospitalizations, and all deaths during, or within three hours after exercise. The secondary safety outcome is the composite of all exercise related injuries for which medical attention is sought.

NCT ID: NCT02814539 Completed - Clinical trials for Congenital Heart Disease

Brain Function in Children With Congenital Heart Disease (CHD)

Start date: March 2016
Phase:
Study type: Observational

The purpose of the study is to determine whether the neurodevelopmental outcome and in particular executive functions in 9 to 14 year old school children with congenital heart disease who underwent cardiopulmonary bypass surgery during their first three months of life is impaired in comparison to healthy children at same age. Executive functions are higher order cognitive functions and critical for school success.

NCT ID: NCT02791061 Active, not recruiting - Clinical trials for Congenital Heart Disease

Study of RV Remodeling in Congenital Heart Disease

RVShape
Start date: January 2013
Phase: N/A
Study type: Observational

The primary aims of this study are to 1. Develop an automated method of quantitation of RV remodeling in terms of regional RV surface curvature and area strain and assess the feasibility, repeatability and accuracy in normal subjects and patients with repaired TOF, patients with PS The secondary study aims of this study are to 1. Compare the differences of RV remodeling in repaired TOF patients, PS patients with sex and age-matched controls 2, Assess the relationship of our proposed parameters to global RV function and exercise capacity in repaired TOF patients and PS patient

NCT ID: NCT02769624 Terminated - Clinical trials for Congenital Heart Disease

Acute Effects of Inhaled Treprostinil in Fontan Patients

Start date: February 21, 2017
Phase: Phase 2
Study type: Interventional

In this pilot study investigators propose to explore the effects of a locally delivered inhaled pulmonary vasodilator (inhaled treprostinil) on exercise performance, pulmonary blood flow, venous pressure response and vascular function in stable Fontan patients. Investigators will also assess the effects of resting and acute rises in exercise induced systemic venous pressure on liver stiffness and will also assess whether treprostinil will attenuate the acute stiffness increase that investigators expect to see. This will be a prospective, randomized, double-blinded placebo controlled, crossover trial. Following recruitment and informed consent, each participant will undergo three study visits, including baseline testing (visit 1), followed by two sets of exercise and vascular function tests (visit 2 and visit 3) at CCHMC. Twenty-six patients will be enrolled in this study.

NCT ID: NCT02759263 Completed - Clinical trials for Congenital Heart Disease

Improving Neurodevelopment in Adolescents With Congenital Heart Disease

Start date: June 2016
Phase: N/A
Study type: Interventional

Executive dysfunction can profoundly impact all dimensions of a child's development. Impairments in executive function are a central component of the neurodevelopmental phenotype associated with CHD, and manifest as behavioral dysregulation and problems with attention, working memory, and organization/planning abilities. Identifying effective treatment strategies is vital for providing optimal care for these patients. The Cogmed executive function intervention, an evidence-based computerized neurocognitive program, improves outcomes in several pediatric populations. The investigators propose to conduct a pilot study to evaluate its efficacy in reducing morbidities in patients with CHD. This is a single center, single blinded 2-arm randomized controlled trial to test the immediate post-treatment and 3-month follow-up efficacy of Cogmed intervention versus standard of care in adolescents with CHD.

NCT ID: NCT02753348 Completed - Clinical trials for Congenital Heart Disease

Copenhagen Baby Heart

Start date: April 2016
Phase:
Study type: Observational

Copenhagen Baby Heart is an observational, cohort study of >30.000 children born in the Copenhagen area 2016-2018. Newborns are examined with echocardiography, electrocardiogram, measurements of oxygen saturation and analyses of umbilical cord blood. The main objectives of the baseline assessments in Copenhagen Baby Heart are to assess the prevalence of congenital and inherited heart disease unrecognized prenatally, to assess the yield of routine echocardiography shortly after birth and to establish reference values for echocardiography in Danish neonates. Prospective follow-up of the birth cohort is planned with the purpose to assess the life-long development of cardiovascular disease as well as other conditions and to study associations between both pre- and postnatal exposure and disease, including life style, environmental and genetic factors.

NCT ID: NCT02746029 Completed - Clinical trials for Congenital Heart Disease

Cardiac Murmurs in Children: Predictive Value of Cardiac Markers

CAMUS
Start date: September 2016
Phase:
Study type: Observational

Heart murmurs are commonly discovered in young children during clinical encounters in general practice. Heart murmurs might signal a structural cardiac disease that need to be treated, such as atrial septal defect. Thus, children with heart murmurs are routinely referred to comprehensive cardiac examination at a paediatric hospital department featuring echocardiography ('gold standard'). However, the great majority of such murmurs are innocent or physiological; ie., they do not represent a cardiac disorder. The prevalence of such innocent murmurs during routine random auscultation is estimated at 30 %. It would be advantageous if patients with a heart disease to a greater extent could be identified at the general practitioners' office: - Healthy children would not be exposed to comprehensive cardiac examination - The burden on the family would subside. - Scarce medical resources in highly specialized departments would be better allocated, to the benefit of patients with real heart disease. The primary aim of this study is to establish the predictive value of cardiac markers in children with heart murmurs. Secondary aims are a) To do a pilot study of pediatric cardiac ultrasound examination in general practice; b) To establish age-adjusted reference range for cardiac markers in children, and c) To explore aspects of cardiovascular physiology in children. The investigators will include a total of 500 children aged 4 weeks to 10 years who is consecutively referred to the Dept. of Paediatrics, Akershus University Hospital, for assessment of heart murmurs. All participants will be subjected to clinical examination, symptom assessment, pulse oximetry, blood sampling (for troponin T, proBNP and other biomarkers), ECG recording, and echocardiography. A randomized subgroup of children will also undergo echocardiography performed by a general practitioner who has not received formal training in pediatric cardiology. The value of possible predictors will be assessed through the construction of Receiver Operating Characteristics (ROC) curves, and calculation of negative predictive value.

NCT ID: NCT02737644 Completed - Clinical trials for Congenital Heart Disease

Peri-conception Key Nutritional Factors and Congenital Heart Disease

PKNFCHD
Start date: March 2016
Phase:
Study type: Observational

The study is a nested case-control study and the purpose is to describe the status of key nutrients(eg.folic acid and vitamins) supplementation among pregnant women in Shanghai, to find out the association between the level of serum key nutrients during peri-conceptional period and the incidence of congenital heart defects (CHD) in newborn, and to provide better preconception care.

NCT ID: NCT02731248 Recruiting - Clinical trials for Congenital Heart Disease

Pulse Oximeter Screening in Congenital Heart Disease

POX
Start date: April 2016
Phase: N/A
Study type: Observational

Pulse oximetry screening of newborn infants increases early detection of critical congenital heart disease and minimises the risk of circulatory collapse before surgery. This study provides an update on the implementation of pulse oximetry screening in Turkey

NCT ID: NCT02728128 Completed - Heart Failure Clinical Trials

Platelet and Tissue cAMP: Novel Biomarkers of Milrinone Efficacy in Children

Start date: August 2016
Phase:
Study type: Observational

The purpose of this study is to identify if circulating platelet cyclic adenosine monophosphate (cAMP) levels can be used as a biomarker of milrinone efficacy in children following cardiac surgery or undergoing heart transplant.