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Heart Defects, Congenital clinical trials

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NCT ID: NCT05203874 Recruiting - Clinical trials for Congenital Heart Disease

Contribution of Multimodal Imaging in Early Coarctation

CT-COARCT-PED
Start date: January 1, 2022
Phase:
Study type: Observational

The CT-Coarct-PED study is a multicentred observational study aiming to describe the population of early coarctation during the last 10 years in South of France. The secondary objective is to assess the importance of cross-sectional imaging in the surgical management of aortic coarctation in the first year of life

NCT ID: NCT05198583 Recruiting - Clinical trials for Heart Defects, Congenital

EF Intervention in Children With Severe Congenital Heart Disease

E-FIT
Start date: July 1, 2022
Phase: N/A
Study type: Interventional

Survival rates of children with severe congenital heart disease (CHD) have increased with ongoing medical progress over the past decades. However, many children with CHD face academic challenges during adolescence, which are associated with executive dysfunction. Executive functions (EF), higher-order cognitive processes allowing goal-directed behavior, can be particularly affected in children with CHD. To improve EF in affected children, a specific EF intervention has been developed. The intervention lasts a total of 8 weeks and is structured in 3 modules. The first module consists of a weekly strategy training in which problems resulting from executive dysfunction are addressed. Online games form the second module. These are games implemented online to promote EF through play. The third module is also based on games: The families receive several board games to play together at home. This third module is voluntary. This intervention is tested on its feasibility. As the intervention was built in a patient centered manner, we expect it to be feasible, showing in a high adherence rate and satisfaction.

NCT ID: NCT05196438 Not yet recruiting - Clinical trials for Congenital Heart Disease

Patterns of Congenital Heart Diseases at Sohag University Hospital

Start date: January 15, 2022
Phase:
Study type: Observational

Congenital heart diseases (CHD) are structural or functional heart diseases that present at birth even if it is discovered later in life . Congenital heart disease is caused by disturbance in the normal development of the heart especially during the first 6 weeks of pregnancy. Researchers aren't sure about the exact cause , but they think genetics , certain medical conditions , some medications and environmental factors, such as smoking, may play a role . CHD in many cases may be asymptomatic and discovered accidently during the routine examination or may be presented by some clinical manifestations (e.g. Cyanosis or Murmers) and /or complications (e.g. Heart Failure Manifestations : Tachycardia , Tachypnea , Dyspnea during feeding , Diaphoresis especially during feeding ,Restlessness, irritability , Hepatomegaly , and Failure To Thrive) . Recently diagnosis of congenital heart disease is better by using advanced technology e.g. echocardiography, magnetic resonance imaging (MRI), cardiac catheterization, angiography, and radio-active isotopes . and early diagnosis is very important as regard the manangement of the disease . As medical care and surgical interventions have advanced over time, the treatment of many abnormalities is now available . and many infants and children with congenital heart defects are living longer and healthier lives. Many are living into adulthood, requiring ongoing, lifelong medical care for their conditions . So information about different aspects of CHD is very important for planning health programs for long-term care and maintenance for these cases .

NCT ID: NCT05195788 Enrolling by invitation - Clinical trials for Congenital Heart Disease

Cardiac Rehabilitation in Congenital Heart Disease: Effects on Brain and Cognitive Functions

CongeNIRS
Start date: February 7, 2022
Phase: N/A
Study type: Interventional

The proposed trial is designed to evaluate the effect of an individualised cardiac rehabilitation program, consisting of aerobic and muscle strengthening exercises, on brain activity and cognitive functions in adults with congenital heart disease

NCT ID: NCT05191654 Completed - Down Syndrome Clinical Trials

Investigation of Cardiopulmonary Parameters, Motor Development and Muscle Strength in DS With and Without CHD

Start date: October 1, 2020
Phase:
Study type: Observational

Congenital heart diseases (CHD) are detected in 40-60% of individuals with Down syndrome (DS) and increase the risk of developmental delay in the presence of syndromes. The aim of the study was to compare cardiopulmonary parameters, gross motor development and hand grip strength in DS children with and without CHD. Demographic variables, cardiopulmonary parameters and echocardiographic values were recorded. Gross motor development was evaluated with Gross Motor Function Measure (GMFM-88). Hand grip strength was measured with the Baseline Pneumatic Bulb Dynamometer.

NCT ID: NCT05186415 Recruiting - Tetralogy of Fallot Clinical Trials

Contrast Enhanced Three Dimensional Echocardiographic Quantification of Right Ventricular Volumes in Repaired Congenital Heart Disease

Start date: August 23, 2022
Phase: Phase 1/Phase 2
Study type: Interventional

We propose the novel integration of two echocardiographic technologies - three-dimensional echocardiography using semi-automated right ventricular analysis coupled with the administration of ultrasound enhancing agents - to improve the inter-rater reliability and accuracy of various measures of right ventricular size and function, compared with cardiac MRI.

NCT ID: NCT05185232 Not yet recruiting - Clinical trials for Congenital Heart Disease

Congenital Heart Initiative-Redefining Outcomes and Navigation to Adult Centered Care

CHI-RON
Start date: April 1, 2022
Phase:
Study type: Observational [Patient Registry]

Congenital heart defects (CHDs) are a heterogeneous group of rare diseases of varying severity, each diagnosis with its unique set of co-morbidities. In addition to the heterogeneity, perhaps the greatest challenge to conducting comparative effectiveness research in CHD patients are the poor rates of successful transition from pediatric to adult centered cardiology care and high rates of gaps in recommend care for adults with CHD. This study will use PCORnet to examine the effects of gaps in recommended care (cardiology visits) on patient prioritized outcomes for adults with non-complex and complex subtypes of CHD. This system will be established through 14 (12 recruiting) PCORnet affiliated institutions and linkage to the Congenital Heart Initiative registry (https://chi.eurekaplatform.org), the first patient powered registry for adults with CHD. This registry launched in December 2020, and is IRB approved at Children's National Hospital (IRB# Pro00014697). Funded by PCORI, this project will recruit patients at the 12 PCORnet affiliated institutions and will invite them to contribute their health records data and then join the established Congenital Heart Initiative. By enrolling patients and linking their PCORnet (health record) data into an existing adult congenital heart disease (ACHD) specific registry, future interventions to reduce gaps in care based on study findings can be rapidly implemented in real-world settings through the strong partnerships established with key CHD stakeholders.

NCT ID: NCT05154864 Completed - Inflammation Clinical Trials

Ultrafiltration in Pediatric Cardiac Surgery: An Observational Cohort Study

Start date: August 1, 2020
Phase:
Study type: Observational

Infants and children undergoing cardiac surgery with cardiopulmonary bypass (CPB) can experience systemic inflammation that prolongs post-operative recovery. Ultrafiltration is an intra-opreative technique that is hypothesized to extract circulating inflammatory mediators during the CPB time. There have been only a few small studies looking at a limited number of inflammatory marker profiles in this context. Our institution uses an innovative form of ultrafiltration "subzero-balance simple-modified ultrafiltration" (SBUF-SMUF) throughout the entire CPB time. SBUF-SMUF has been our standard of care for the last 5 years. This observational seeks to describe the clinical and immunologic outcomes of infants and children undergoing cardiac surgery with CBP and SBUF-SMUF.

NCT ID: NCT05143177 Recruiting - Clinical trials for Calcific Aortic Valve Disease

A Study to Evaluate the Efficacy and Safety of DA-1229 (Evogliptin) in Patient's Calcific Aortic Valve Disease With Mild to Moderate Aortic Stenosis (EVOID-AS)

Start date: June 27, 2022
Phase: Phase 2/Phase 3
Study type: Interventional

This is an adaptive Phase 2/3 multicenter, double-blind, placebo-controlled, randomized, parallel, 3 arm study to evaluate the efficacy and safety of DA-1229 compared to placebo in patients with calcific aortic valve disease with mild to moderate aortic stenosis. There are 3 arms in this study to which patients will be randomized in a ratio of 1:1:1 to receive the DA-1229 or placebo orally once daily for a period of 104 weeks . the 3 arms are: placebo, DA-1229 5mg GroupDA-1229 10 mg Group. The study will have three phases: Screening Period (up to 4 weeks), Treatment Period (104 weeks), and Follow-Up Period (2-4 weeks). Total Study Duration is112 Weeks.

NCT ID: NCT05142046 Completed - Surgery Clinical Trials

Influence of Intraoperative Fluid Balance on the Incidence of Adverse Events in Pediatric Cardiac Surgery

Start date: March 1, 2022
Phase:
Study type: Observational

The intraoperative fluid balance during pediatric cardiac surgery is a very sensitive parameter given the low circulating volume and the complexity of anesthetic management but might be deleterious if inadequately managed. The hypothesis is that a highly positive intraoperative fluid balance increases the incidence of adverse events in the short and long term. A retrospective observational study including all consecutive children admitted for cardiac surgery with cardiopulmonary bypass (CPB) from 2008 to 2018 in a tertiary children's hospital will be performed. A multivariate analysis will be carried out to study the effect of the fluid balance on the incidence of adverse events.