View clinical trials related to Complex Congenital Heart Disease.
Filter by:Heart failure in adults with congenital heart disease is a major cause of morbidity and mortality. Patients with systemic right ventricle (SRV) and single ventricle (SV) are particularly at risk1, 2, 3. There are no specific recommendations for the management of heart failure in adults with congenital heart disease, whose management is based on "general cardiology" recommendations4,5. Sacubitril/Valsartan is validated as a treatment for heart failure in adults with acquired pathological left ventricular dysfunction (left ventricular ejection fraction (LVEF) < 40%, New York Heart Association (NYHA) functional class II and III despite optimal heart failure therapy)7. Although this molecule is used in current practice in patients with congenital heart disease, published data are limited 6-10. The aim of our work is to describe the efficacy and tolerability of Sacubitril/Valsartan in the treatment of chronic heart failure on VDS and VU through an observational, prospective, multicenter registry. The latest heart failure treatment guidelines, updated in 202111, recommend the addition of type 2 sodium-glucose co-transport inhibitors in heart failure patients with impaired ejection fraction (class IA recommendation). Two molecules are used in current practice: dapagliflozin and empagliflozin, at a single dosage of 10 mg/day. We will also be collecting data on the efficacy and safety of iSGLT2. It should be noted that, for practical reasons, there may be a delay between the end of the 1st study period (ISACC1) of one year and the start of the 2nd study period (ISACC2). Follow-up examinations carried out during the study period will not differ from those currently recommended in current practice5.
Follow-up of patients with complex congenital heart disease (CHD) usually involves ultrasound imaging or even MRI or CT scans of the heart and stress testing. But these examinations can be challenged in terms of their sensitivity. Thus, the development of non-invasive jugular venous and radial arterial pressure sensors, reflecting the hemodynamic function of the right heart, would be very useful to the clinician responsible for early detection of a deficit in right ventricular function.
This study is a multicenter, stepwise design, cluster randomized controlled trial. Random sequence is generated by computer, and each center enters the intervention expectation (Phase I) in random order to implement ERAS strategy. If it does not enter the intervention expectation (Phase C) center, clinical diagnosis and treatment will be completed according to the traditional scheme. Among children, patients aged 28 to 6 who underwent cardiac surgery were included in the ERAS strategy intervention plan, which mainly includes preoperative education, preoperative comfort for the patient, preoperative oral sugary beverage, continuous infusion of dexmedetomidine, multimodal analgesia, blood protection strategies, prevention of postoperative nausea and vomiting, intraoperative insulation, early tracheal extubation and intubation, and targeted liquid therapy. The traditional plan group follows the current clinical diagnosis and treatment routine. By comparing the differences in the incidence of major postoperative outcomes (MACE events, major pulmonary complications, and acute kidney injury) between the intervention group and the non intervention group, as well as comparing other adverse events (including but not limited to pneumonia, massive bleeding, postoperative arrhythmia, incision infection, postoperative nausea, vomiting, and delirium), all cause secondary intubation, and all cause secondary surgery between the two groups, and recording hospitalization time, ICU stay time The removal time of tracheal intubation and drainage tube, the pain score during hospitalization, the total amount of opioid drug use (converted to the same dose of morphine), hospitalization expenses, and family satisfaction scores were recorded to explore whether the ERAS regimen can reduce the incidence of major postoperative adverse events, improve patient prognosis, and accelerate postoperative recovery compared to traditional regimens.
Determine 1) the impact of abnormal fetal cerebrovascular physiology with neurodevelopmental delay (ND) outcomes and 2) how this relationship is modified by patient and environmental factors such as chronic congenital heart disease (CCHD) lesion, maternal-fetal environment, and social determinants of heath (SDOH) in a diverse population using a multicenter design. Pregnant women will be approached during one of their fetal cardiology clinic visits.
Feasibility of non-invasive cerebral autoregulation measurement at the PICU and impact of changes in oxygen supply
We propose a prospective observational study whose main objective will be to determine whether there is an association between age at surgery (days of life) and neurodevelopmental outcome in patients with CCHD. Secondly, we will study the relationship between age at surgery and (i) the incidence of WMI observed on pre- and post-operative cerebral MRI (ii) post-operative morbidity as defined by the occurrence of post-operative complications (haemodynamic, infectious, neurological, surgical) and (iii) the length of hospital stay.
An injury of haematosis in post ischemic chronic heart failure limits the clinic tolerance. There is a correlation between injury of pulmonary diffusing, chronic heart failure intensity and aerobic physic ability evaluated by an heart-rate maximal exercise tolerance test (VO2 max). This injury is a new follow-up parameter of cardiac function for the adult. The nature of damage (vascular or membrane) can be determined by the measure of double pulmonary diffusing capacity to carbon monoxide (CO) associated to nitric oxide (NO). Today, in chronic heart failure consecutive to a congenital heart disease, there is no data on evolution of membrane and capillar factors.It is impossible to predict if membrane damage will be the best factor correlated to the VO2max in patients suffering from complex congenital heart disease. Assessing these parameters could be an comparative evaluation of heart-rate exercise tolerance test with VO2max and an early control of his damage without risks related to heart-rate maximal exercise and independently of age, sex, hemoglobin, type of heart disease.These results would have an early prognostic value that would permit to refine the follow-up and the treatment. The main objective of this trial is to assess the statistic correlation between the membrane injury of alveolar-capillary diffusing at rest and aerobic physic ability restriction in children and adults suffering from complex congenital heart disease.