Clinical Report: The FUEL FALD Trial: Impact of Udenafil on Liver Stiffness
Overview
The FUEL FALD trial assessed the impact of udenafil on liver stiffness and fibrosis in patients post-Fontan surgery over a 12-month period. The study aimed to evaluate changes in liver stiffness and fibrosis biomarkers in response to udenafil treatment, involving a cohort of patients aged 12-20 years who had undergone Fontan surgery before 5 years of age.
Background
Fontan-associated liver disease (FALD) is a significant long-term complication following Fontan surgery, characterized by progressive liver fibrosis and dysfunction. As survival rates improve for patients with single ventricle congenital heart disease, the recognition and management of FALD have become increasingly important. Current treatment options are limited, with heart transplant being the only validated strategy, highlighting the need for effective therapeutic strategies.
Data Highlights
No numerical data or trial results were provided in the source material, which limits the ability to assess the impact of udenafil on liver stiffness and fibrosis.
Key Findings
Udenafil is a phosphodiesterase-5 inhibitor that may improve exercise capacity in Fontan patients.
The study utilized ultrasound shear wave elastography (SWE) and magnetic resonance elastography (MRE) to assess liver stiffness.
The Enhanced Liver Fibrosis (ELF) score was used as a serologic measure of liver fibrosis.
Chronic hepatic venous hypertension and congestion are believed to drive the development of FALD.
There are currently no validated treatment strategies for FALD other than heart transplant.
Clinical Implications
The findings from the FUEL FALD trial provide insights into the effects of udenafil on liver stiffness in Fontan patients.
Conclusion
The FUEL FALD trial provides insights into the role of udenafil in managing liver stiffness and fibrosis in patients following Fontan surgery.
by Kurt R. Schumacher, Jonathan Dillman, David J. Goldberg, Mark Cartoski, Michael DiMaria, Benjamin Frischhertz, Salil Ginde, Bryan H. Goldstein, Nagraj Kasi, Christine K. Lee, Daniel H. Leung, Chad Y. Mao, Brian W. McCrindle, Shaji Menon, Matthew O’Connor, Alexander R. Opotowsky, Joseph Palermo, Stephen M. Paridon, Daniel Penny, Rahul Rathod, Jonathan B. Wagner, Angela Yetman, Victor Zak, Mark Russell
