The Impact of Carvedilol Posology on Clinically Significant Portal Hypertension

Centro Hospitalar De São João, E.P.E.

Status: Completed

Conditions: Clinically Significant Portal Hypertension

Treatments: Drug: supress the night dose of carvedilol

Study type: Interventional

Funder types: Other

Identifiers

NCT06015373

LHU-2023-001

Details and patient eligibility

About

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).

Enrollment: 34 patients

Sex: All

Ages: 18 to 77 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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34 participants in 1 patient group

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

Experimental group

Description:

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).

Treatment:

Drug: supress the night dose of carvedilol