NCT05767229Completed
Acute Hemodynamic Response to Carvedilol in Children With Clinically Significant Portal Hypertension.
Source: ClinicalTrials.gov · Last updated 8 Jan 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 40 (actual)
- First submitted
- 15 Feb 2023
- Start date
- 13 Mar 2023
- Primary completion date
- 2 Nov 2024
- Lead sponsor
- Institute of Liver and Biliary Sciences, India
- Diseases
- High blood pressure
- NCT number
- NCT05767229
What you commit to
- Study type: Interventional
- Participants enrolled: 40
- From 13 Mar 2023 to the primary completion date, 2 Nov 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients who received beta-blockers in last 7 days
- Patients who received Octreotide infusion or bolus in last 7 days
Other illness
- Uncorrected heart defects (except small ASD)
- Cardiac conduction defects - arrythmias or heart block
- Severe hepatic impairment with MELD or PELD score \>14
- Hyper-reactive airway disease
- Acute congestive heart failure
Other
- Interrupted inferior vena cava
- Situs inversus
- Variceal bleed in last 48 hours
- Shock or active sepsis
- Grade 2 /grade 3 ascites
- Acute kidney injury (any grade)
- Hepatic encephalopathy (any grade)
- Known contraindications to propranolol in children:
- Hypertrophic cardiomyopathy
Who the study is looking for
- All children 2-18 years of age with CLD defined as presence of either of the following histological evidence of advanced fibrosis more than F2 on METAVIR staging or radiological imaging suggestive (heterogeneous hepatic echotexture, irregular nodular liver and/or caudate hypertrophy). .
- Splenomegaly and/or platelets \</= 100 (X10\^3/mm3)
- Coming for upper gastrointestinal endoscopy for variceal screening
- Informed consent for HVPG and UGIE
Age in the registry: 2 years to 18 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Institute of Liver & Biliary Sciences Coordinator of this site? Confirm its status | New Delhi | India | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.