The Impact of Carvedilol Posology on Clinically Significant Portal Hypertension

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-01

Study Completion Date

2023-07-31

Brief Summary

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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).

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Detailed Description

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Conditions

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Clinically Significant Portal Hypertension

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Patients with CSPH receiving carvedilol twice daily and supress the night dose of carvedilol

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).

Group Type EXPERIMENTAL

supress the night dose of carvedilol

Intervention Type DRUG

already described

Interventions

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supress the night dose of carvedilol

already described

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

77 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes