The Impact of Carvedilol Posology on Clinically Significant Portal Hypertension

NCT06015373 | Completed DMC

• 1 other identifier: LHU-2023-001
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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).

Conditions

Clinically Significant Portal Hypertension

Keywords

portal hypertension; carvedilol; elastography

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• liver stiffness measurement (LSM)

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

Study Arms (1)

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

EXPERIMENTAL

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

Interventions

supress the night dose of carvedilol DRUG

already described

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

Eligibility Criteria

• Age: 18 Years - 77 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients with CSPH (defined as a LSM 25 kPa or SSM over 45kPa prior to introduction of carvedilol)

You may not qualify if:

• 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

Sponsors & Collaborators

• Centro Hospitalar De São João, E.P.E.: lead

Study Sites (1)

Centro Hospitalar de Trás os Montes e Alto Douro

Vila Real, Lordelo, 5000-508, Portugal

Location

MeSH Terms

Conditions

Hypertension, Portal

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Principal Investigator

Study Record Dates

• First Submitted: August 11, 2023
• First Posted: August 29, 2023
• Study Start: June 1, 2023
• Primary Completion: June 30, 2023
• Study Completion: July 31, 2023
• Last Updated: August 29, 2023

Record last verified: 2023-08

Locations

PT (1)