NCT04908657

Sildenafil for Liver Fibrosis in Adolescents and Adults After Fontan Operation

Status unknown Phase 4 Last updated 8 June 2022

What this trial tests

Phase 4 trial testing Sildenafil 20 MG in Liver Fibrosis in 40 participants. Status unknown.

Timeline

3 July 2017

Primary endpoint
1 July 2023

31 December 2023

Quick facts

Lead sponsor	National Taiwan University Hospital
Phase	Phase 4
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	40
Start date	3 July 2017
Primary completion	1 July 2023
Estimated completion	31 December 2023
Sites	1 location across Taiwan

Drugs / interventions tested

• Sildenafil 20 MG — full drug profile →

Conditions studied

• Liver Fibrosis — all drugs for Liver Fibrosis →

Sponsor

National Taiwan University Hospital

Who can join

12 and older, any sex, with Liver Fibrosis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Fontan operation is currently the most common procedure performed in patients with single-ventricle physiology. This surgery allows for passive caval blood flow to the pulmonary arteries in the absence of a subpulmonary pump and therefore separating the pulmonary circulation from systemic circulation. However, late hepatic complications such as liver fibrosis, cirrhosis, or even hepatocellular carcinoma are increasingly described in patients with Fontan circulation. The Fontan associated liver disease (FALD) is related to the decreased cardiac output and elevated central venous pressure after Fontan operation. Although the prevalence of FALD is higher than 90% in patients with Fontan circulation. There are no specific medications can reverse the liver fibrosis or prevent the progression of FALD at present. Sildenafil had been used in patients after Fontan operation not only to decrease their pulmonary vascular resistance and central venous pressure, increased systemic cardiac output. Comparing with other oral pulmonary vasodilators, sildenafil is with less possibility of liver toxicity. Therefore, we will conduct a prospective, open-labeled, randomized-controlled study in at least 90 Fontan patients with age \> 12 years receiving follow -up at our institute. These patients will be in accordance with the ratio of 1: 1 distribution randomized into two groups, group 1 will receive sildenafil 20 mg three times daily for 3 years and the group will not receive any pulmonary vasodilator as a control. Patients in both group will receive the examinations of liver fibrosis markers, transient ultrasound elastography (FibroScan), diffusion-weighted magnetic resonance imaging (DW-MRI) and cardiopulmonary function test at baseline, 1 year, 2 years and 3 years after initiating treatment. Comparing the results of two groups, we may further clarify the treatment effect of sildenafil on FALD in patients after Fontan procedure.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Treatment of liver fibrosis: Past, current, and future.
   Zhang CY, Liu S, Yang M. · · 2023 · cited 49× · PMID 37397931 · DOI 10.4254/wjh.v15.i6.755