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Heart Defects, Congenital clinical trials

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NCT ID: NCT03411512 Completed - Clinical trials for Heart Defects, Congenital

Congenital Heart Defects and NIRS

Start date: December 1, 2012
Phase: N/A
Study type: Observational

Congenital Heart Defects and NIRS

NCT ID: NCT03379831 Completed - Clinical trials for Congenital Heart Disease

Correlation Between Quality of Life and Aerobic Physical Fitness of Patients With a Systemic Right Ventricle

Start date: January 12, 2018
Phase:
Study type: Observational

Congenital heart disease (CHD) is the most common congenital malformations. The right ventricle in the sub-aortic position, or "systemic right ventricle" is one of these complex cardiac diseases. Several studies show that adults with CHD and especially systemic right ventricle have reduced exercise capacity. In addition, studies have shown that there is a correlation between alteration of aerobic physical capacity and alteration of right ventricular systolic function. Understanding and assessing the determinants of the physical capacity of patients with systemic right ventricles and evaluating their quality of life could allows us to improve their therapeutic management and also to expand patient indications to a program cardiac rehabilitation. This can benefit them on their exercise capacity, their tolerance to exercise and their quality of life. The aim is to study the correlation between the quality of life and the aerobic physical fitness of patients with a systemic right ventricle and to determine the clinical and paraclinical parameters that have an impact on the aerobic physical fitness of these patients. The quality of life of patients with a systemic right ventricle will be compared to that of the general population.

NCT ID: NCT03360370 Completed - Clinical trials for Congenital Heart Disease

Neurodevelopmental Disorders in Children With Congenital Heart Disease

NeuroDis-CHD
Start date: December 6, 2017
Phase:
Study type: Observational

Children with congenital heart disease are at risk for neurodevelopmental disorders, these disorders impacting their quality of life and their integration into society. The aim of this study is to detect neurodevelopmental disorders in children (aged from 6 to 66 months) with congenital heart disease in Nord-Pas-De-Calais (France) and to evaluate the frequency and risk factors of these neurodevelopmental disorders for a better follow-up. This study will help implementing a specific program for the evaluation and management of neurodevelopmental disorders in children suffering from congenital heart disease in Nord-Pas-De-Calais and more globally, in the region Hauts-De-France.

NCT ID: NCT03348397 Completed - Clinical trials for Congenital Heart Defect

Contegra Versus Pulmonary Homograft for Right Ventricular Outflow Tract Reconstruction in Newborns

Start date: March 1, 2017
Phase: N/A
Study type: Observational

Pulmonary homografts are standard substitutes for right ventricular outflow tract reconstruction in congenital heart surgery. Unfortunately shortage and conduit failure secondary to early calcifications and shrinking are observed particularly for small sized conduits in younger patients. In neonates, Contegra® 12mm could be a valuable alternative, but conflicting evidence exists. This retrospective study compared the outcome of these two conduits in a newborn population.

NCT ID: NCT03335475 Completed - Physical Activity Clinical Trials

Congenital Heart Disease Physical Activity Lifestyle Study

CHD-PALS
Start date: November 7, 2017
Phase: N/A
Study type: Interventional

This study will adapt a physical activity lifestyle intervention to adolescent and emerging adult congenital heart disease (CHD) survivors with the primary goal of increasing physical activity levels. The study will be split into 2 phases. In Phase 1, participants will be asked to complete questionnaires, wear an accelerometer around the waist for 7 days, and undergo an exercise stress test. The accelerometer and exercise stress test will be used to determine whether participants are eligible to be randomized for the intervention study. For adolescent participants, a parent will be asked to complete questionnaires at baseline as well. In Phase 2, participants will be randomized to one of two conditions: 1) receiving a physical activity tracker (a Fitbit) or 2) receiving a Fitbit AND engaging in videoconferencing sessions with a physical activity coach. During Phase 2, participants will also be asked to complete 3 assessments (weeks 9 and 22, and a 6-month follow-up). The week 9 assessment will consist of completing questionnaires and wearing an accelerometer for 7 days. Week 22 will be similar to week 9 with the addition of a final exercise stress test. The 6-month follow-up will mirror the week 9 assessment. For adolescent participants, the same parent will be asked to complete questionnaires at the final assessment as well. Participants who are randomized to the videoconferencing condition will be asked to meet with a physical activity coach 8 times over the course of 20 weeks. Coaches will help participants to (1) change attitudes toward physical activity, (2) increase perception of others' approval of physical activity (e.g., family members, peers), and (3) increase participants' perceived control by troubleshooting barriers and increasing efficacy for physical activity. Coaches will use the Fitbit to facilitate self-monitoring and goal setting. Participants in the intervention arm will be asked to participate in a focus group at the conclusion of the study to share their experiences.

NCT ID: NCT03311438 Completed - Dental Plaque Clinical Trials

Oral Health Intervention Program for Children With Congenital Heart Defects

Start date: September 1, 2009
Phase: N/A
Study type: Interventional

Background: Children with congenital heart defects (CHD) are reported to have poorer oral health compared with healthy children. The aim of the present study was to evaluate the effect of an intensive oral health care program among children with CHD followed from infancy to the age of five years, by comparing their oral health status at five years with a control group of children with CHD who had not received the program. Methods: In this longitudinal study, children in western Norway with a need for lifelong follow-up due to congenital heart defects were invited to participate (n=119). Children born in 2008-2011 were offered a promotive oral health intervention program from infancy to the age of five years. The outcome measures for evaluating the intervention were dental caries prevalence, dental erosion, plaque index and gingival bleeding index. The data of the intervention group were compared with cross sectional oral health data of five year old controls with CHD born 2005-2007 (already published).

NCT ID: NCT03262168 Completed - Heart Diseases Clinical Trials

Supported Exercise Programme for Adults With Congenital Heart Disease

SEACHange
Start date: June 2, 2017
Phase: N/A
Study type: Interventional

This study will evaluate if the introduction of a supported exercise programme can improve physical and psychological well-being for adults with congenital heart disease.

NCT ID: NCT03255850 Completed - Clinical trials for Congenital Heart Disease

The Impact of Congenital Heart Disease on the Psychological Well Being and Quality of Life in the Hong Kong Chinese Adolescents

Start date: August 15, 2017
Phase:
Study type: Observational

This study aims to examine the psychological well-being and QoL of Hong Kong Chinese adolescents with CHD by - comparing the self-esteem level, depressive symptoms, and quality of life of adolescents suffering from CHD with healthy norms and cancer survivors. - identifying possible factors affecting the quality of life of adolescents suffering from CHD.

NCT ID: NCT03248830 Completed - Clinical trials for Congenital Heart Disease

Non-invasive Hemoglobin Monitoring in Congenital Heart Diseased Children

Start date: February 20, 2018
Phase:
Study type: Observational

The investigators will evaluate the accuracy of non-invasive hemoglobin monitor (Sp-Hb) compared to traditional laboratory hemoglobin (Lab-Hb) in children with congenital heart disease. The investigators will also compare the accuracy of Sp-Hb in cyanotic children to acyanotic children.

NCT ID: NCT03229538 Completed - Clinical trials for Inflammatory Response

STeroids to REduce Systemic Inflammation After Infant Heart Surgery

STRESS
Start date: October 18, 2017
Phase: Phase 3
Study type: Interventional

This study's objective is to determine the pharmacokinetics (PK)/pharmacodynamics (PD), safety and efficacy of methylprednisolone in infants undergoing heart surgery with cardiopulmonary bypass. This is a prospective, double blind, multi-center, placebo-controlled safety and efficacy study. Blood samples will be collected from a subset of enrolled study participants to evaluate multiple dose methylprednisolone PK/PD. Participants will be randomized in a 1:1 fashion to intravenous methylprednisolone versus placebo. Study drug/placebo will be administered 8 to 12 hours before the anticipated start time of surgery and in the operating room at the time of initiation of cardiopulmonary bypass. Patients will be followed for primary and secondary outcomes for the duration of their hospitalization. Serious study drug-related adverse events will be collected for 7 days after the last dose of study drug.