View clinical trials related to Univentricular Heart.
Filter by:Patients after the Fontan operation at a single institution will be randomized to receive a standardized extract of Aesculus hippocastanum L. (horse chestnut) or placebo for 4 months in a crossover clinical trial. The primary outcome will be the mesenteric artery resistance measured by Dopple sonography.
The congenital heart disease (CHD) is the firts cause of congenital birth defects. Medical and surgical advances completely changed the epidemiology of CHD. Among these CHD, the univentricular heart, or single ventricle (SV), is a disease whose medical-surgical progress has completely changed the epidemiology. The SV at birth receives systemic and pulmonary venous returns in the single functional cavity and provides systemic and pulmonary flow. The SV undergoes a severe volumetric overload and considerably increases its work, which is not viable for the long time. In 1968, Professor Francis Fontan created the palliative surgery of the univentricular heart. It consists in establishing a derivation of the systemic venous blood from the two vena cava veins directly to the pulmonary arteries, without a sub-pulmonary ventricle. So, the VU no longer undergoes volumetric overload, and eliminates cyanosis. In this "Fontan circulation", there is no pump to push the blood in the pulmonary arteries, only the remaining systemic post-capillary energy (reflection of the central venous pressure) allows to drive the blood through the lungs with a risk of stasis upstream (right overload) and a limited pre-charge downstream, which can lead to severe consequences: limited exercise capacity, systolic and diastolic dysfunction of the SV, arrhythmia, cyanosis, cirrhosis and hepatic carcinoma, exudative enteropathy , plastic bronchitis, venous thromboses, deaths. There is a great heterogeneity within this family of SV with extremely varied evolutionary profiles. The cardiorespiratory exercise test, which has become a "gold standard", makes it possible to assess the severity of CHD. In our study on the aerobic fitness of children with CHD, the investigators found that 44% of children with SV had normal aerobic fitness (> 80% of the theoretical VO2max)1. Some good prognostic criteria are already described: left SV, good VU function, total cavopulmonary shunt in young age, etc. But the investigators know that these elements are not enough to explain why some SV, which the investigators will call the "great-SV", have a better aerobic fitness. The main objective of our study is to describe the population of "great SV" (VO2max ≥ 80%) within the general population of SV. The investigators thus wish to determine the prognostic criteria favorable to a good aerobic fitness in univenticular heart disease.
In univentricular hearts, selective lung vasodilators such as phosphodiesterase type 5 (PDE5) inhibitors would decrease pulmonary resistance and improve exercise tolerance. However, the level of evidence for the use of PDE5 inhibitors in patients with a single ventricle (SV) remains limited. the investigators present the SV-INHIBITION study rationale, design and methods.The SV-INHIBITION trial is a nationwide multicentre, randomised, double blind, placebo-controlled, phase III study, aiming to evaluate the efficacy of sildenafil on the ventilatory efficiency during exercise, in teenagers and adult patients (>15 y.o.) with a SV. Patients with pulmonary arterial hypertension (mean pulmonary arterial pressure (mPAP) > 15 mmHg and trans-pulmonary gradient > 5 mmHg) measured by cardiac catheterisation, will be eligible. The primary outcome is the variation of the VE/VCO2 slope, measured by a cardiopulmonary exercise test, between baseline and 6 months of treatment. A total of 50 patients are required to observe a decrease of 5 ± 5 points in the VE/VCO2 slope, with a power of 90% power and an alpha risk of 5%. The secondary outcomes are: clinical outcomes, 6 minute walk test, SV function, NT Pro BNP, VO2max, stroke volume, mPAP, trans-pulmonary gradient, SF36 quality of life score, safety and acceptability. This study aims to answer the question whether PDE5 inhibitors should be prescribed in patients with a SV. This trial has been built focusing on the 3 levels of research defined by the WHO: disability (exercise tolerance), deficit (SV function), and handicap (quality of life).
This is a prospective, multi-center, open-label, PK and safety profile study of enteral digoxin in children <6 months old at time of enrollment, post-surgical or hybrid stage 1 palliation, but prior to surgical stage 2 palliation.
The aim is to evaluate the correlation between the respiratory control to hypercapnia at rest and the VE/VCO2 slope measured during cardiopulmonary exercise testing. The hypothesis is that patient with univentricular congenital heart disease have a increasing of respiratory drive like chronic heart failure. This increasing of respiratory drive could participate in the increasing of VE/VCO2 slope measured during cardiopulmonary exercise testing and in the genese of central apnea index during the sleep.
Adolescents with single ventricle heart disease (SVHD) (10 males and 10 females) with mild to moderate cognitive impairment will participate in a total of 25 computer-based working memory training sessions, each 30-40 minutes (5 days a week for 5 weeks) supervised by a trained coach. Primary objective is to evaluate the impact of the Cogmed intervention on working memory scores and the secondary objective to assess brain tissue changes with magnetic resonance imaging (MRI) using diffusion tensor imaging (DTI) techniques, measures of mean diffusivity pre- and post-intervention.
The investigators found that there is inflammation in the chest drainage in patients after the Fontan operation. The investigators want to test the theory that Colchicine, an anti- inflammatory medication, can decrease the inflammation in the chest tube drainage after the Fontan operation, and can decrease the amount of time that patients having this surgery will have drainage.
The overarching goal of this project is to discern how closure of Fontan fenestrations in patients with single ventricle heart disease will affect hepatic congestion, a major determinant of chronic liver disease. We will employ transient elastography (Fibroscan) to obtain liver stiffness measurements (LSM) before and after fenestration closure to study the impact of this intervention on hepatic congestion.
This study aims to determine what are some of the clinical characteristics and associations of Fontan patients who are doing well, as well as how accurate cardiology providers are at predicting the likelihood of future adverse event in their Fontan patients.
This is a novel preliminary study of biomarkers of pathologic pre-operative pulmonary vascular development, elevated pre-operative Pulmonary Vascular Resistance Index (PVRi), and complications associated with decreased post-operative pulmonary blood flow in single ventricle patients undergoing superior cavo-pulmonary anastomosis (SCPA). The study will utilize a combined targeted and untargeted approach to both optimize translation of a promising existing biomarker and efficiently identify novel biomarkers and potential therapeutic targets in this population.