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NCT06762964
The purpose of this research is to determine whether treatment with the study drug dapagliflozin for 3 months affects peripheral venous pressure at rest and during exercise in adults with failing Fontan circulation.
NCT07220226
The aim of this study is to investigate whether venous compression garments increase exercise stroke volume in patients with Fontan circulation. To address this aim, we will test the following hypotheses: 1. Acute and chronic external venous compression will increase exercise stroke volume in patients with Fontan circulation. 2. Patients with significant venous varicosities will have a greater response to venous compression. Participants will: * Undergo submaximal exercise testing in MRI to measure venous return and exercise stroke volume with and without the wearing of compression garments * Undergo submaximal exercise testing on a seated upright exercise ergometer with concurrent measurement of stroke volume with and without the wearing of compression garments * A subset of participants will repeat both testing visits after wearing compression garments for 2-weeks during waking hours. Participants will: * Undergo submaximal exercise testing in MRI to measure venous return and exercise stroke volume with and without the wearing of compression garments * Undergo submaximal exercise testing on a seated upright exercise ergometer with concurrent measurement of stroke volume with and without the wearing of compression garments * A subset of participants will repeat both testing visits after wearing compression garments for 2-weeks during waking hours.
NCT06731322
This observational case-control study aims to investigate intestinal barrier dysfunction, systemic inflammation, and nutritional status in adult patients after Fontan operation. Fontan operation, a palliative intervention for complex congenital heart defects, leads to an elevated systemic venous pressure, contributing to systemic complications, including gastrointestinal disturbances and liver disease. While protein-losing enteropathy (PLE) is a known complication, this study focuses on patients without PLE to assess less-studied effects on the gastrointestinal system. The elevated systemic venous pressure in adult patients after Fontan operation may impair the protective and absorptive functions of the gastrointestinal tract. This dysfunction allows bacterial endotoxins to enter the bloodstream, triggering systemic inflammation, which can worsen heart failure, cause malnutrition, and lead to cachexia. Although these outcomes are established in acquired heart failure, there is a lack of studies specifically examining the gastrointestinal consequences in adult patients after Fontan operation without PLE. In this study, adult Fontan patients without PLE will be compared to a control group of healthy adults or adult patients with simple congenital heart defects and normal systemic venous pressure. The study will evaluate intestinal barrier dysfunction, systemic inflammatory responses, and malnutrition through several methods: serum biomarkers (I-FABP, LBP, TNF-α, IL-6, etc.), nutritional assessment including body composition assessment using bioelectrical impedance analysis and measurements of serum microelements, echocardiography, and abdominal ultrasound with liver elastography. The findings of the study will help elucidate the connection between intestinal barrier dysfunction, inflammation, and nutritional status in adult patients after Fontan operation, aiming to improve long-term outcomes for this unique patient population.
NCT06324396
This is a single center, open-label, prospective, investigation to quantify the effects liver congestion and fibrosis has on hepatic drug metabolism and transport in children, adolescents, and young adults with Fontan circulation.
NCT06258382
In the Swedish registry for congenital heart defects, SWEDCON, over 230 patients with single-ventricle circulation are registered in the adult section. Congenital heart defects affect career choices, family planning, and leisure activities. Questions regarding heredity and pregnancy are common. The impact of Fontan circulation on reproductive health and fertility needs to be illuminated, and additional studies are required from both medical and psychosocial perspectives.Cognitive impairment is common among patients with congenital heart defects but is likely an overlooked cause of long-term illness. Objective To study a large national population (n=200) of adults with Fontan circulation and their potential partners regarding. * the prevalence and explanatory factors for sexual dysfunction and infertility in women and men with Fontan circulation (Study A). * the outcomes of pregnancy, choice of delivery mode, and complications in patients with Fontan circulation (Study B). * the experiences and perceptions of becoming parents among women (n=20) and men (n=20), as well as elucidate reasoning and family planning among women and men (n=20) who have not become parents (Study C). * Investigate the prevalence and explanatory factors for (Sub-study D): * Fatigue * In-depth cognitive screening to describe specific cognitive functions such as auditory memory, visuospatial memory, attention, cognitive speed, and executive functions. The aim of this research is to gain more knowledge in an area that has been relatively underexplored, thus improving care for women and men with congenital heart defects.
NCT06197763
This is the first pilot study proposing a novel therapeutic option treating patients with Fontan circulation (FC), a high-risk condition that has no definite treatment options available, other than heart or heart-liver transplantation. The investigator's identification of elevated BA and their association with adverse clinical - investigational features in Fontan patients are novel.
NCT00964782
The study will test the hypothesis that a single dose of sildenafil can increase the exercise capacity of pediatric patients with a Fontan Circulation.