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Heart Defects, Congenital clinical trials

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NCT ID: NCT05838079 Recruiting - Clinical trials for Congenital Heart Disease

Copenhagen Baby Heart Study - Impact

CBHS-I
Start date: November 1, 2018
Phase:
Study type: Observational

Copenhagen Baby Heart Study - Impact (CBHS-I) is an extension to Copenhagen Baby Heart (CBH) which included over 25.000 new-borns in the Copenhagen area between 2016-2018. Based on clinical and subclinical deviations in the examinations in CBH, subgroups of participants will be invited to clinical examinations (echocardiography and electrocardiogram) in early childhood. There will also be a new, targeted inclusion based on certain exposures during pregnancy. The main objectives are to assess the prevalence of congenital and inherited heart disease and, and the development of these during early childhood; examining the association between pre- and postnatal exposure, disease, lifestyle, environmental and genetic factors; continue to establish reference values for echocardiography in Danish neonates and children.

NCT ID: NCT05828524 Recruiting - Clinical trials for Congenital Heart Disease

Outcome of Balloon Pulmonary Valvuloplasty in Patients With Congenital Pulmonary Stenosis in Terms of Reverse Right Ventricular Remodelling and Functional Exercise Capacity

Start date: January 10, 2021
Phase:
Study type: Observational

A prospective of 30 patients with symptomatic severe congenital valvular pulmonary stenosis who are indicated for percutaneous balloon pulmonary valvuloplasty . the aim is to 1. - evaluate electrical and mechanical remodeling of RV 6 months following balloon dilation 2. - evaluate Functional capacity using 6MWT and SaO2 before and 6 months following BPV

NCT ID: NCT05826769 Recruiting - Clinical trials for Congenital Heart Disease in Children

To Assess the Efficacy of Early Administration of Energy Enriched and Protein Enriched Formula in Post Cardiac Repair Infants: a Randomized Controlled Trial, Comparative Study

Start date: July 21, 2021
Phase: N/A
Study type: Interventional

Congenital heart disease (CHD) is a public health problem, A substantial percentage of infants and toddlers with CHD undergo cardiopulmonary bypass surgery. Undernutrition affects up to 90% of these patients, and it's contributed to worse surgical and neurological outcomes. Infants with CHD are typically delivered at full term with a normal birth weight. However, as time passes, their development may become stunted. There are no negotiated guidelines for nutritional monitoring and intervention in this age bracket of infants. Through the use of Energy Enriched and Protein Enriched nutrition formula during the postoperative phase, this has shown to be well tolerated and support in delivering higher nutrition intakes within the first days after surgery. The objective of this research is to assess the long term outcome of patients who have had energy- and protein-rich nutrition formulas post cardiac surgery. An open, 2-arm, randomized controlled trials will be conducted to assess the efficacy of early administration of energy enriched and protein enriched formula in post cardiac repair infants. The expected primary outcome is that intervention group will have good tolerance to feeding and the secondary outcome is the significant weight gain rate (weight velocity) in comparing to control groups

NCT ID: NCT05824650 Completed - Frailty Clinical Trials

Frailty and Non-Fragile Congenital Heart Disease

Start date: April 20, 2023
Phase:
Study type: Observational

Congenital heart disease (CHD) is defined as congenital functional or anatomical abnormalities of the heart and intrathoracic great vessels. This study, which is planned to be carried out, will enable people with CHD to present a holistic perspective when planning rehabilitation programs and to create a common language for all health professionals.

NCT ID: NCT05819788 Recruiting - Clinical trials for Congenital Heart Disease

FFP Usage in Pediatric CV Surgery

Start date: August 28, 2023
Phase:
Study type: Observational

When small children undergo heart surgery with the heart-lung machine, in the past, blood products to help the blood clot such as Fresh Frozen Plasma (FFP) was routinely used in children under 10kg. With blood clot monitoring technology, we feel that it might not be necessary to expose all children to FFP. We want to determine if those children who did not receive FFP bleed more or require more blood products as compared to those who did receive FFP while on the heart lung machine.

NCT ID: NCT05809310 Recruiting - Clinical trials for Congenital Heart Disease

Effects Branch PA Stenting d-TGA, ToF and TA

Start date: April 18, 2023
Phase: N/A
Study type: Interventional

The goal of this randomized controlled trial is to identify the effects of percutaneous interventions for branch PA stenosis on exercise capacity in patients with d-TGA, ToF and TA. The main question[s] it aims to answer are: The primary study objective is to identify the effects of percutaneous interventions for branch PA stenosis on exercise capacity in patients with d-TGA, ToF and TA. The secondary objectives are 1) to assess the effects of percutaneous interventions for branch PA stenosis on RV function and 2) to define early markers for RV function and adaptation to improve timing of these interventions. Participants will undergo the same series of examinations at baseline and approximately 6 months follow-up (within 6 week time-range) as part of standard care: conventional transthoracic echocardiogram (TTE), cardiopulmonary exercise testing (CPET) and conventional Cardiac Magnetic Resonance (CMR) including a low dose dobutamine stress MRI to assess RV functional reserve. The low dose dobutamine stress MRI will be performed in the interventional group from the UMC Utrecht/WKZ and Erasmus MC because the LUMC and AUMC do not have a suitable infrastructure for the low dose dobutamine stress MRI and this cannot be achieved throughout the duration of this study. The baseline CMR in the interventional group will be performed as close as possible prior to the intervention but maximal 4 weeks prior to the intervention. In addition, the intervention group will undergo standard RV pressure measurements during the intervention. Quality of life (QoL) questionnaires will be obtained at baseline and 2 weeks post intervention (intervention group) or a similar time range in the control group, which is based on experts opinion. TTE, CPET and conventional CMR will be performed within 2-4 years follow-up to assess the long-term effects of percutaneous PA interventions. Researchers will compare the difference in VO2 max (% predicted) between the interventional group (TGA, ToF or TA patients with a class II indication for a PA intervention who will undergo a percutaneous intervention for a PA stenosis) and the control group (TGA, ToF or TA patients with a class II indication for a PA intervention who will undergo conservative management)

NCT ID: NCT05800691 Completed - Clinical trials for Cyanotic Congenital Heart Disease

Predicting Factors for Mortality in Congenital Heart Disease Patients After Shunt Procedure in Developing Country.

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

Blalock Taussig (BT) is a palliative procedure that preserves blood circulation to the lungs and alleviates cyanosis in patients with congenital heart diseases and reduced pulmonary blood flow. BT shunt remains a routinely performed procedure in developing countries before definitive surgery. However, evidence on predictors factors of mortality after this procedure is still scarce in Indonesia.

NCT ID: NCT05778240 Completed - Clinical trials for Congenital Heart Disease in Children

Adherence to Palivizumab Prophylaxis

Start date: October 1, 2020
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to analyze implications of two alternative nudge-interventions to increase adherence to palivizumab prophylaxis in children with congenital heart disease. The main questions investigators aim to answer are: - Are well-established cognitive biases effective in increasing patient families' adherence to the palivizumab prophylaxis program? - What are the factors that affect families' adherence to the prophylaxis program and whether and how the effects of interventions depend on these factors? To study these questions investigators planned to utilize four well-established cognitive biases in designing two alternative nudge-interventions and investigators measured the effectiveness of each nudge-intervention against a control group. Patients were randomly allocated to one control and two treatment groups. In the control group, investigators informed participants about the prophylaxis program and provided a schedule. Patients in the first treatment group were additionally called two days before appointments (status quo bias), and were asked to plan the appointment day (implementation intention). Patients in the second treatment group received biweekly messages informing them about the benefits of the program as well as the current adherence rate (availability bias and social norm).

NCT ID: NCT05778175 Not yet recruiting - Clinical trials for Congenital Heart Disease in Children

Common Cases in Pediatric Intensive Care in Assuit University Cardiology Institute, a Clinical Audit

Start date: May 1, 2023
Phase:
Study type: Observational

1Evaluation of the management methods according to guidelines for cardiac patients admitted to Intensive care in pediatric Assuit university cardiology institute and the effectiveness and outcome of following of these medications comparing them with international advanced centers. Types of shocks in cardiac patients and management of cardiogenic shock needs especial concern.

NCT ID: NCT05774158 Recruiting - Quality of Life Clinical Trials

Investigation of Adults With Congenital Heart Disease in the Scope of the ICF

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

Congenital heart disease (CHD) is one of the common birth defects with a prevalence of approximately 1 in 1000 live births worldwide. While 15% of patients with CHD reached adulthood in the past, this rate is close to 90% today thanks to advancing medicine and technology.As individuals with CHD age, they may be affected by acquired cardiovascular risk factors common in the general population in addition to heart diseases such as arterial hypertension, obesity, and diabetes, increasing the risk of metabolic disease, stroke, and coronary artery disease. In addition to these risk factors, the disease affects both the social and familial environment of the patients. In addition to the mortality and morbidity of patients, which was the most important outcome measure in the past, quality of life has become the subject of current research. The International Classification of Functioning and Health (ICF) was adopted in 2001 for the use of a common, standard language and framework for describing health and health-related conditions, and is an international and standardized classification system that can evaluate functioning, disability and health holistically. There are no studies in the literature evaluating body structure, function and activity and participation in adults with congenital heart disease within the scope of ICF. Therefore, the aim of this study is; It is the evaluation of adults with CHD according to ICF sub-parameters (body structure and functions, activity and participation, and environmental factors) and the correlation of ICF parameters with other evaluation methods.