The Impact of Carvedilol Posology on Clinically Significant Portal Hypertension

Study Overview
=================
Brief Summary
-----------------
Carvedilol has emerged as the preferred non-selective β-blocker (NSBB) for treating portal hypertension. However, there is still a debate in dosing regimen, specially regarding dose interval, with a potential lower bioavalability in once daily regimens. The aim of this study is to assess the acute effects of carvedilol posology in patients with clinically significant portal hypertension (CSPH), as a surrogate marker of bioavailability. In this experimental study, patients with CSPH receiving carvedilol twice daily were asked to supress the night dose of carvedilol, in order to have a dose interval of approximately 24 hours. Spleen stiffness measurement (SSM) by transient elastography (TE) was performed and compared with SSM prior or under treatment. Same procedure was applied to liver stiffness measurement (LSM).

Official Title
-----------------
The Impact of Carvedilol Posology on Clinically Significant Portal Hypertension: Insights From Elastography Measurements

Conditions
-----------------
Clinically Significant Portal Hypertension

Intervention / Treatment
-----------------
* Drug: supress the night dose of carvedilol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with CSPH (defined as a LSM 25 kPa or SSM over 45kPa prior to introduction of carvedilol) Exclusion Criteria: Non-responders to non-selective β-blockers (NSBB) NSBB other than carvedilol Dosing regimen other than twice daily No SSM or LSM within 3 months prior to the beginning of the study Body mass index (BMI) > 30 m/kg2 Contraindications to NSBB use Portal venous thrombosis Refusal to participate in the study Failure to comply to the study regimen

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 77 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients with CSPH receiving carvedilol twice daily and supress the night dose of carvedilol<br>In this experimental study, 34 patients with CSPH receiving carvedilol twice daily were asked to supress the night dose of carvedilol, in order to have a dose interval of approximately 24 hours. Spleen stiffness measurement (SSM) by transient elastography (TE) was performed and compared with SSM prior or under treatment. Same procedure was applied to liver stiffness measurement (LSM). | Drug: supress the night dose of carvedilol<br>* already described<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| spleen stiffness measurement (SSM) | Change from baseline in spleen stiffness measurement (SSM) measured by transient elastography (TE) after 24 hour suspension of carvedilol treatment. | Baseline SSM measured up to 3 months before enrolment, and measured at 24 hours after suspending carvedilol | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| liver stiffness measurement (LSM) | Change from baseline in liver stiffness measurement (LSM) measured by transient elastography (TE) after 24 hour suspension of carvedilol treatment. | Baseline LSM measured up to 3 months before enrolment, and measured at 24 hours after suspending carvedilol | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
portal hypertension, elastography, carvedilol