The Impact of Carvedilol Posology on Clinically Significant Portal Hypertension

Centro Hospitalar De São João, E.P.E.34 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Clinically Significant Portal Hypertension

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 77 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

spleen stiffness measurement (SSM)

Change from baseline in spleen stiffness measurement (SSM) measured by transient elastography (TE) after 24 hour suspension of carvedilol treatment.

Time frame: Baseline SSM measured up to 3 months before enrolment, and measured at 24 hours after suspending carvedilol

Secondary Outcomes

liver stiffness measurement (LSM)

Change from baseline in liver stiffness measurement (LSM) measured by transient elastography (TE) after 24 hour suspension of carvedilol treatment.

Time frame: Baseline LSM measured up to 3 months before enrolment, and measured at 24 hours after suspending carvedilol