The Impact of Carvedilol Posology on Clinically Significant Portal Hypertension

August 24, 2023 updated by: Bruno Besteiro, Centro Hospitalar De São João, E.P.E.

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

34

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Portugal
    • Lordelo
      • Vila Real, Lordelo, Portugal, 5000-508
        • Centro Hospitalar de Trás os Montes e Alto Douro

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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).
Drug: supress the night dose of carvedilol
already described

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
spleen stiffness measurement (SSM)
Time Frame: Baseline SSM measured up to 3 months before enrolment, and measured at 24 hours after suspending carvedilol
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
liver stiffness measurement (LSM)
Time Frame: Baseline LSM measured up to 3 months before enrolment, and measured at 24 hours after suspending carvedilol
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centro Hospitalar De São João, E.P.E.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2023

Primary Completion (Actual)

June 30, 2023

Study Completion (Actual)

July 31, 2023

Study Registration Dates

First Submitted

August 11, 2023

First Submitted That Met QC Criteria

August 24, 2023

First Posted (Actual)

August 29, 2023

Study Record Updates

Last Update Posted (Actual)

August 29, 2023

Last Update Submitted That Met QC Criteria

August 24, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LHU-2023-001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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