Acute Hemodynamic Response to Carvedilol in Children With Clinically Significant Portal Hypertension.
Status:
Not yet recruiting
Trial end date:
2025-02-14
Target enrollment:
Participant gender:
Summary
Clinically significant portal hypertension (CSPH) is defined as Hepatic Venous Pressure
gradient (HVPG) >10 mmHg. Patients with CSPH are at risk of developing esophageal varices and
clinical decompensation (variceal bleeding, ascites, jaundice, encephalopathy), which mark
the transition from compensated stage to a stage of the disease (decompensated) associated
with higher mortality. HVPG is calculated by subtracting the free hepatic venous pressure
(FHVP), a measure of systemic pressure, from the wedged hepatic venous pressure (WHVP), a
measure of hepatic sinusoidal pressure. HVPG is surrogate marker in many clinical
applications such as gold standard test to evaluate presence and severity of portal
hypertension (PHT) diagnosis, risk stratification, monitoring of the patients on beta
blockers. Non-selective beta-blockers like propranolol and carvedilol are indicated in adults
for primary and secondary prophylaxis of variceal hemorrhage. Acute hemodynamic response to
intravenous propranolol with HVPG values coming down to < 12 mm Hg or reduction to >20% from
baseline have been shown to be associated with reduced long-term risk of variceal bleed.
Portal Hypertension in biliary atresia (BA) occurs early and is due to recurrent cholangitis
and portal sclerosis. HVPG in children is feasible and safe in children according to previous
studies, however, there are no recommendations to suggest beta-blockers based on HVPG
reduction in children. Hence, we are planning the current work to study the acute hemodynamic
response to carvedilol in children with CSPH, and to compare the HVPG values in children with
chronic liver disease.