[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"fontan-procedure\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:fontan-procedure":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,40],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":15,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":39},"100429121","development-of-4d-flow-mri-for-risk-stratification-of-variceal-bleeding-in-cirrhosis-100429121",false,"NCT04867954","Development of 4D Flow MRI for Risk Stratification of Variceal Bleeding in Cirrhosis","Inclusion Criteria for Aim 1:\n\n* Healthy volunteers: Adults (\\>18 years) with no known liver pathology\n* Obese volunteers: Adults (\\>18 years), no known liver pathology, body mass index (BMI) ≥ 35\n* Patients: Adults (\\>18 years) with known cirrhosis and known Gastroesophageal varices\n\nExclusion Criteria for Aim 1:\n\n* contraindications to MRI\n* hypersensitivity reactions to both contrast agents\n* patients with recent treatment for varices with embolization, TIPS, or other endovascular treatment\n* patients with active GEV bleeding; known occlusive thrombus in portal vein, splenic vein, or superior mesenteric vein.\n* patients with large HCC with known PC involvement.\n\nInclusion criteria for Aim 2-4:\n\n* Adults (\\>18 years) with known cirrhosis\n\nExclusion Criteria for Aim 2-4:\n\n* Contraindications to MRI\n* Recent treatment (\\\u003C 1 year) for varices\n* Known occlusive thrombus in portal vein; splenic vein, or superior mesenteric vein\n* Large hepatocellular carcinoma (HCC) with known PV involvement\n* Hypersensitivity reactions to both contrast agents\n* Participants requiring conscious sedation for imaging are not eligible; participants requiring mild, oral anxiolytics for the clinical MRI scan will be allowed to participate as long as the following criteria are met:\n\n  * The participant has their own prescription for the medication\n  * The informed consent process is conducted prior to the self-administration of the medication.\n  * The participant comes to the research visit with a driver.\n\nInclusion Criteria for Aim 5:\n\n* Adults (\\>18 years) with Fontan repair and diagnosed FALD\n\nExclusion Criteria for Aim 5:\n\n* Contraindications to MRI\n* Recent treatment (\\\u003C 1 year) for varices\n* Known occlusive thrombus in portal vein; splenic vein, or superior mesenteric vein\n* Large hepatocellular carcinoma (HCC) with known PV involvement\n* Hypersensitivity reactions to both contrast agents\n* Participants requiring conscious sedation for imaging are not eligible; participants requiring mild, oral anxiolytics for the clinical MRI scan will be allowed to participate as long as the following criteria are met:\n\n  * The participant has their own prescription for the medication\n  * The informed consent process is conducted prior to the self-administration of the medication.\n  * The participant comes to the research visit with a driver.",true,"ALL","18 Years",{"count":19,"type":20},146,"ESTIMATED","OBSERVATIONAL","The goal of this research is to validate novel non-invasive Magnetic resonance imaging (MRI) biomarkers to detect Gastroesophageal varices (GEV) in patients with cirrhosis, including fractional flow change in the portal vein and elevated azygos flow.\n\nEnd-stage liver disease (cirrhosis) is characterized by advanced fibrosis, liver failure, and portal hypertension. There are many causes of cirrhosis, including viral hepatitis, alcohol abuse, and perhaps most importantly, non-alcoholic fatty liver disease (NAFLD) and its aggressive subset, non-alcoholic steatohepatitis (NASH). 3 million new cases of end-stage liver disease (cirrhosis) are expected over the next decade. In cirrhosis, portosystemic collaterals that shunt blood away from the liver develop due to increased portal pressure. Gastroesophageal varices (GEV) are the most clinically relevant because they can cause fatal internal bleeding. GEV bleeding carries \\~20% mortality at 6 weeks, and \\~34% overall mortality. Identification of at-risk varices, prior to bleeding, is of paramount importance to initiate primary prophylaxis. To identify and treat at-risk patients, current guidelines recommend regular esophagogastroduodenoscopy (EGD) and variceal band ligation. Detection of high-risk GEV is key to initiating primary prophylaxis, which can reduce mortality by 50-70%.\n\nHowever, endoscopy is invasive and often unnecessary when no treatment is required. Therefore, the American Association for the Study of Liver Diseases has identified the development of \"non-invasive markers that predict the presence of high-risk varices\" as a major unmet need.",[24,25,26],"Cirrhosis, Liver","Gastroesophageal Varices","Fontan Procedure","RECRUITING","2026-04-07",{"date":30,"type":31},"2026-04-09","ACTUAL",{"date":33,"type":31},"2021-10-28",{"date":35,"type":20},"2026-06-30",{"name":37,"class":38},"University of Wisconsin, Madison","OTHER",1,{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":4,"eligibilityCriteria":46,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":47,"enrollmentInfo":48,"targetDuration":4,"studyType":50,"phases":51,"briefSummary":53,"conditions":54,"keywords":62,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":39},"100602108","the-ipeer2peer-mentorship-program-for-young-adults-with-heart-disease-100602108","NCT07119216","The iPeer2Peer Mentorship Program for Young Adults With Heart Disease","The iPeer2Peer Support Mentorship Program for Young Adult Patients With Heart Disease: A Feasibility Study","Inclusion Criteria:\n\n* Peer Mentor inclusion criteria: (a) heart disease patients, (b) at least three months post-diagnosis, (c) between the ages of 26-35 years old, (d) nominated by a member of their healthcare team as a good candidate to act in the mentor role based on maturity and emotional stability (e.g., good communication skills, positive adaptation and adjustment, strong support network), (e) willingness to commit to virtual peer mentor training, (f) able to speak and read English, and (g) access to a device (e.g., smart phone, tablet, computer) capable of using free WhatsApp software.\n* Peer Mentee inclusion criteria: (a) heart disease patients, (b) between the ages of 18-25 years old, (c) able to speak and read English, and (d) access to a device (e.g., smart phone, tablet, computer) capable of using free WhatsApp software.\n\nHeart disease patients include:\n\n* Patients with any past or present heart failure\n* Patients with cardiomyopathy seen at least 2 times a year\n* Patients who have undergone a Fontan procedure\n* Patients who have undergone a heart transplant\n\nExclusion Criteria:\n\n* Mentor and mentee exclusion criteria include: (a) Significant cognitive impairments as assessed by a qualified healthcare provider (HCP), (b) have a diagnosis of an active psychological disorder (e.g.: Major Depressive Disorder, etc.; determined through chart review by a qualified HCP) likely to influence assessment of health-related quality of life and\u002For interfere with their ability to manage their heart disease care regimen, and (c) are participating in other peer support or self-management interventions.","35 Years",{"count":49,"type":20},80,"INTERVENTIONAL",[52],"NA","Young adults with heart failure, including those who have undergone a heart transplant, experience considerable psychosocial stressors associated with living with a chronic illness, including heightened levels of anxiety and depression, and poor health-related quality of life compared to 'healthy' peers. Psychosocial challenges during young adulthood are especially concerning as this life stage represents a unique transitional period for fostering self-identity, friendships, mastery, and decision-making competencies. As young people with heart failure transition into adult healthcare systems, they take on greater personal responsibility due to their increasing independence and involvement in care decisions, and require more support and resources to live longer, healthier lives. Peer support provided by a person with a similar experience has been found to improve disease self-management and psychosocial health outcomes in pediatric healthcare.\n\nAn established, online mentorship program, iPeer2Peer (iP2P), will be employed through a pilot feasibility waitlist randomized controlled trial with repeated measures across five sites. Sixty mentees will be recruited and randomized into intervention and control groups. Thirty mentees in the intervention group will be matched 1:1 with 20 trained mentors. These pairings will connect over 12 weeks through video calls and text messaging to provide peer support to improve self-management and psychosocial health outcomes.",[55,56,57,58,59,60,61,26],"Heart Failure","Mentorship","Peer Support","Peer Support and Chronic Disease","Young Adults","Cardiomyopathies","Heart Transplant Recipient",[63,64,65,66,67],"heart failure","mentorship","peer support","young adult","heart disease","NOT_YET_RECRUITING","2025-08-05",{"date":71,"type":31},"2025-08-13",{"date":73,"type":20},"2025-09",{"date":75,"type":20},"2027-12",{"name":77,"class":38},"Samantha Anthony"]