Clinical Research Directory

Development of 4D Flow MRI for Risk Stratification of Variceal Bleeding in Cirrhosis

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. End-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%. However, 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.

An Observational Study to Learn More About How Safe Rivaroxaban is And How Well it Works in Children With Congenital Heart Disease Who Had a Heart Surgery Called the Fontan Procedure

This is an observational study in which the data from children with congenital heart disease will be collected and studied. These children will include those who are prescribed rivaroxaban by their doctors after a heart surgery called the Fontan procedure. Congenital heart disease (CHD) is a heart problem that some children are born with. It sometimes requires a surgery called the Fontan procedure to improve the blood flow in the body. The Fontan procedure can increase the risk of the formation of blood clots in the blood vessels (called thrombosis), which might lead to death. The study drug, rivaroxaban, is an approved treatment for preventing the formation of blood clots. It is a type of anticoagulant that prevents the blood from clotting by blocking a protein responsible for it. Rivaroxaban can increase the risk of bleeding. A previous study suggested that the number of major bleeding episodes did not differ much while taking rivaroxaban compared to aspirin in children with CHD who had undergone the Fontan procedure. However, there is limited information available for Japanese patients. To better understand the safety and potential risks of this drug in children, more knowledge is needed about the use of rivaroxaban in the real world. The main purpose of this study is to learn more about the occurrence of major bleeding or non-major bleeding in children who were treated with rivaroxaban. Major bleeding is defined as a serious or life-threatening bleeding episode that can have an impact on a person's health and requires medical attention. Non-major bleeding is defined as a type of bleeding that may negatively impact a person's health if not treated. The data will be collected from December 2023 to June 2026. Researchers will observe each participant for up to 30 days after stopping the treatment or for a maximum of 2 years. In this study, only available data from regular health visits will be collected. No visits or tests are required as part of this study. Researchers will use the medical records or interview the children and/or their guardians during regular visits.

The iPeer2Peer Mentorship Program for Young Adults With Heart Disease

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. An 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.