The Impact of Carvedilol Posology on Clinically Significant Portal Hypertension

Clinically Significant Portal Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06015373
• Other study ID #: LHU-2023-001
• Status: Completed
• Phase: N/A
• Start date: June 1, 2023
• Est. completion date: July 31, 2023

Study information

• Verified date: August 2023
• Source: Centro Hospitalar De São João, E.P.E.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: July 31, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 77 Years

Eligibility

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 ß-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

Related Conditions & MeSH terms

• Clinically Significant Portal Hypertension
• Hypertension
• Hypertension, Portal

Intervention

Drug:
• supress the night dose of carvedilol
already described

Locations

Country	Name	City	State
Portugal	Centro Hospitalar de Trás os Montes e Alto Douro	Vila Real	Lordelo

Sponsors (1)

Lead Sponsor	Collaborator
Centro Hospitalar De São João, E.P.E.

Country where clinical trial is conducted

Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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