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Heart Defects, Congenital clinical trials

View clinical trials related to Heart Defects, Congenital.

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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: NCT02737579 Completed - Clinical trials for Congenital Heart Defect

XFM: (X-ray Fused With MRI) Guided Cardiac Catheterization

Start date: July 23, 2013
Phase: N/A
Study type: Interventional

This study will evaluate the use of x-ray fused with MR images as an imaging tool to help guide catheter tools during diagnostic and therapeutic cardiac catheterization procedures.

NCT ID: NCT02712606 Completed - Clinical trials for Cyanotic Congenital Heart Disease

Accuracy of Pulse Oximeter With Hypoxemic Measurements

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

A study about accuracy of pulse oximeter with hypoxemic measurements (Blue sensor, Masimo, Irvine, CA, USA) in children with cyanotic congenital heart disease

NCT ID: NCT02710825 Completed - Clinical trials for Congenital Heart Disease

Osteopathy and Children With Congenital Heart Disease Surgery

OSCAR
Start date: May 2016
Phase: N/A
Study type: Interventional

Osteopathic care impact on postoperative pain assessed by osteopathic session, evaluated by EVENDOL scale surgery on children with congenital heart disease

NCT ID: NCT02704351 Completed - Clinical trials for Surgery for Congenital Heart Disease

Suggamadex and Fast-track Cardiac Anesthesia in a Developing Country

Start date: February 2016
Phase:
Study type: Observational

The purpose of this study is to retrospectively review our preliminary experience during a surgical trip to Tuxtla, Mexico, using suggamadex to reverse neuromuscular blockade following CPB and cardiac surgery for repair of CHD in infants and children.

NCT ID: NCT02700737 Completed - Clinical trials for Cardiovascular Disease

Evaluation of Image-Based Modelling on Clinical Decisions in Coarctation of the Aorta

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

To answer the research question: "Would image-based modelling result in different clinical decisions as compared to clinical practice guidelines?", we will conduct a randomized controlled experiment in which we will compare the hypothetical decisions made by interventional cardiologists who are presented with imaging parameters currently recommended by clinical practice guidelines vs. hypothetical decisions made by interventional cardiologists receiving an expanded list of parameters, including simulation modelling.

NCT ID: NCT02692443 Completed - Clinical trials for Congenital Heart Disease

SVR III: Brain Connectome and Neurodevelopmental Outcomes

SVRIII
Start date: August 2015
Phase:
Study type: Observational

Patients with hypoplastic left heart syndrome and other single right ventricle lesions who have undergone the Fontan procedure have a high risk of neurodevelopmental disorders that affect quality of life and adulthood employment. This study will leverage the ongoing National Heart, Lung, and Blood Institute (NHLBI)-funded Single Ventricle Reconstruction Study by using innovative graph measures of brain connectivity to elucidate how alterations of the "connectome" in children with critical congenital heart disease are associated with developmental disabilities and their associated clinical risk factors. Improved understanding of these interrelationships may facilitate development of targeted interventions to improve outcome in the soaring population of adult Fontan survivors.

NCT ID: NCT02686255 Completed - Clinical trials for Congenital Cardiac Defects

Hemoglobin Trend in Neonates and Toddlers Post Cardiac Surgery

Start date: May 2016
Phase:
Study type: Observational

Many toddlers and children are released home with relatively low hemoglobin levels following cardiac surgery, and with no careful follow up, at an age at which anemia is common. At this age, breast milk and its substitute do not provide enough iron, and parents are not adherent enough to iron supplements. Due to these facts, there is high importance, especially in children suffering from heart defects, for close follow up on their hemoglobin levels. Studies following hemoglobin trend post cardiac surgery were never done with children.

NCT ID: NCT02675361 Completed - Clinical trials for Congenital Heart Disease

Effectiveness of a Transition Program for Adolescents With Congenital Heart Disease in the Transition to Adulthood

Start date: July 1, 2016
Phase: N/A
Study type: Interventional

This study is part of a larger research project known as Swedish Transition Effects Project Supporting Teenagers with chrONic mEdical conditionS (STEPSTONES). This project was created to develop and evaluate transition programs in order to support adolescents with chronic conditions in Sweden. While STEPSTONES has a generic nature, the first transition program that will be evaluated targets adolescents with congenital heart disease (ConHD). This particular study involves a hybrid experimental design, meaning a randomized controlled trial is embedded in a longitudinal, observational study. This type of design will help to test the effectiveness of a transition program in order to empower adolescents with congenital heart disease in the transition to adulthood and check for potential contamination of the comparison group. We will recruit 210 participants: 140 adolescents will be part of the randomized controlled trial (70 in the intervention arm; 70 in the comparison arm), and 70 participants will be assigned to the observational, longitudinal arm of the study, which serves as control group in an intervention-naive center. Over a period of two years, three assessments will be done during which all participants will be asked to answer a set of questionnaires. The intervention to be tested involves patient empowerment, education on their ConHD, dealing with school, health behaviors required to maintain good health, guidance of parents, a person-centered transition plan, among others. The study hypothesis is that adolescents with ConHD who received a structured, person-centered transition program over a 2-year period have a higher patient empowerment score than adolescents who receive usual care.