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Heart Defects, Congenital clinical trials

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NCT ID: NCT03153137 Completed - Clinical trials for Congenital Heart Disease

Clinical Study Assessing the Efficacy and Safety of Macitentan in Fontan-palliated Subjects

RUBATO
Start date: August 14, 2017
Phase: Phase 3
Study type: Interventional

The primary objective is to assess the effect of macitentan 10 mg as compared to placebo on exercise capacity through cardiopulmonary exercise testing.

NCT ID: NCT03152773 Recruiting - Clinical trials for Congenital Heart Disease

Heart Catheterization Using Magnetic Resonance Imaging (MRI) Fluoroscopy and Passive Guidewires

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

Background: A heart catheterization is a diagnostic heart procedure used to measure pressures and take pictures of the blood flow through the heart chambers. Magnetic resonance imaging (MRI) fluoroscopy shows continuous pictures of the heart chambers that doctors can watch while they work. Researchers want to test this procedure with catheterization tools routinely used in x-ray catheterization called guidewires. Guidewires will help move the heart catheter through the different heart chambers. Guidewires are usually considered unsafe during MRI because MRI can cause a guidewire to heat while inside the blood vessels and heart. Researchers are testing special low energy MRI settings that allow certain guidewires to be used during MRI catheterization without heating. Using these guidewires during MRI may help to decrease the amount of time you are in the MRI scanner, and the overall time the MRI catheterization procedure takes. Objectives: To test if certain MRI settings make it safe to use a guidewire during MRI fluoroscopy. Eligibility: Adults 18 and older whose doctors have recommended right heart catheterization. Design: Researchers will screen participants by reviewing their lab results and questionnaire answers. Participants may give 4 blood samples. Participants will be sedated. They will have a tube (catheter) placed in the groin, arm, or neck if they don t already have one. Patches on the skin will monitor heart rhythm. Special antennas, covered in pads, will be placed against the body. Participants will lie flat on a table that slides in and out of the MRI scanner as it makes pictures. Participants will get earplugs for the loud knocking noise. They can talk on an intercom. They will be inside the scanner for up to 2 hours. They can ask to stop at any time. During a heart catheterization, catheters will be inserted through the tubes already in place. The catheters are guided by MRI fluoroscopy into the chambers of the heart and vessels. The guidewire will help position the catheter.

NCT ID: NCT03149341 Enrolling by invitation - Clinical trials for Pulmonary Hypertension

MRI and Computational Simulation Cardiology Study

Start date: February 2008
Phase:
Study type: Observational

The purpose of this study is to (1) quantify cardiovascular anatomy and physiology using magnetic resonance imaging under both resting and exercise conditions in patients who have congenital heart disease and in age-matched normal volunteers, (2) use computer models to reproduce and simulate blood flow in these patients, and then (3) to combine the imaging data and computer models to estimate values which cannot be directly measured and to predict physiological changes induced by exercise and medical or surgical therapies.

NCT ID: NCT03147014 Recruiting - Clinical trials for Hypoplastic Left Heart Syndrome

Cardiovascular Response to Maternal Hyperoxygenation in Fetal Congenital Heart Disease

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

Cardiovascular Response to Maternal Hyperoxygenation in Fetal Congenital Heart Disease

NCT ID: NCT03146143 Completed - Clinical trials for Congenital Cardiac Disorders

Ultrafiltration Effect on Extravascular Lung Water in Pediatric Cardiac Surgery

Start date: May 15, 2017
Phase: N/A
Study type: Interventional

study will assess the effect the ultrafiltration after pediatric congenital heart surgery on cardiopulmonary bypass. patients will be divided into two groups. first group will receive ultrafiltration and the second group will be control group without filtration. we will assess extravascular lung water by lung ultrasound, arterial oxygen tension and duration of ventilation.

NCT ID: NCT03144258 Completed - Clinical trials for Congenital Heart Disease

Evaluation of the Microcirculation During the Corrective Surgery of Congenital Heart Defects in Children

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

General objective of the research project: To evaluate the alterations of systemic microvascular reactivity during cardiopulmonary bypass (CPB), in children submitted to cardiac surgery for repair of congenital heart defects.

NCT ID: NCT03144011 Completed - Clinical trials for Cardiopulmonary Bypass

Acute Kidney Injury in Children After Cardiopulmonary Bypass

Start date: February 8, 2017
Phase:
Study type: Observational

Acute kidney injury (AKI) is a common complication in patients with congenital heart defects after cardiopulmonary bypass. The death rate from AKI in critically ill children remains high and reaches 60%. The basic criteria for diagnosing and assessing the severity of kidney injury until recently were the level of serum creatinine and the amount of urine released. However, it should be noted that the level of serum creatinine, traditionally used to assess renal function, does not significantly increase until a decrease of more than 50% of the glomerular filtration rate, in addition, its level depends also on some extrarenal causes. Artificial blood circulation and hemodilution leads to the preservation of the level of creatinine at sufficiently low levels up to 1-3 days postoperative period. The level of diuresis as well as the level of creatinine is a nonspecific criterion after cardiac surgery and depends on several factors. Currently, in the field of acute renal injury studies, progress has been made in the emergence of new biomarkers such as the tissue inhibitor metalloproteinase-2 (TIMP-2) and insulin-like growth factor binding globulin-7 (IGFBP7), which are early markers of acute renal damage. In a study in adult patients, it was shown that the levels of TIMP-2 and IGFBP7 increased In the first 24-48 before the diagnosis of IR-associated renal damage. Among pediatric patients with congenital heart defects, such studies are single and only present for the age group 3 and older, which also demonstrated the high specificity and prognostic significance of these biomarkers in the early diagnosis of acute renal damage. It should also be noted that, in spite of the high specificity of the markers described, it is also necessary to note their considerable cost. Thus, taking into account the above, it is planned to compare and identify the relationship of these indicators with such parameter as the index of renal vascular resistance, the increase of which in the pre- and postoperative period may serve as a sign of the beginning acute renal injury.

NCT ID: NCT03143348 Completed - Inflammation Clinical Trials

Prognostic Markers of Inflammation in Infants Undergoing Cardiopulmonary Bypass

ProCard
Start date: June 4, 2017
Phase:
Study type: Observational

This study evaluates the effect of heart-lung bypass on babies undergoing cardiac surgery. The investigators want to learn more about the inflammation that exposure to bypass creates in the body by studying markers of inflammation and cell injury in the bloodstream. Additionally, the investigators want to examine if these markers can predict which babies develop post-surgical complications. The hypothesis is that babies who undergo bypass will have higher levels of these markers than babies not exposed to bypass and that these markers will correlate with how the baby does clinically after surgery. This study will evaluate markers via blood sampling in babies with congenital heart disease who do not undergo cardiac surgery, those that undergo surgery without bypass, and those that undergo surgery with bypass. The overall goal is that this study will lead to useful biomarkers and lay the groundwork for future novel therapies aimed at improving outcomes for babies who require heart-lung bypass.

NCT ID: NCT03142685 Withdrawn - Clinical trials for Congenital Heart Disease

Utility of Bowel Ultrasound in Diagnosing Necrotizing Eneterocolitis in Congenital Heart Disease

Start date: January 1, 2017
Phase: N/A
Study type: Interventional

To evaluate the feasibility of performing a randomized pilot control trial of two diagnostic screening strategies for necrotizing enterocolitis in patients with congenital heart disease. Measures to evaluate will be the ability to obtain consent from patients, percentage of eligible patients that are able to be recruited, coordination of providers, estimation of degree of crossover and ability to perform the screening exams per protocol.

NCT ID: NCT03136900 Terminated - Clinical trials for Congenital Heart Disease in Children

Impact on the Nitrogen Balance, Autonomy, Safety and Tolerance of Enteral Diets Made of With Nutrilon Without Lactose® Fortified by Concentration Versus by Maltodextrin and Oil Supplementation,After Surgery for Congenital Heart Disease, in Infants.

DIETCHIRCARD
Start date: May 3, 2017
Phase: N/A
Study type: Interventional

An adequate nutritional support after a cardiac surgery enhances the morbidity and mortality. After a cardiac surgery, the energy expenditure is estimated to be around 55 kcal/kg/d. The caloric intake is not the only important nutritional variable in PICU. The protein intake objective is around 1,5g/kg/d in order to reduce muscular catabolism. The aim of this study is to compare the impact of an isocaloric enteral diet, either fortified by milk concentration (in order to increase the protein intake) or by a supplement of maltodextrin and oil in children from 0 to 2 years, after surgery for congenital heart disease.