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The Impact of Carvedilol Posology on Clinically Significant Portal Hypertension

Primary Purpose

Clinically Significant Portal Hypertension

Status
Completed
Phase
Not Applicable
Locations
Portugal
Study Type
Interventional
Intervention
supress the night dose of carvedilol
Sponsored by
Centro Hospitalar De São João, E.P.E.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Clinically Significant Portal Hypertension focused on measuring portal hypertension, carvedilol, elastography

Eligibility Criteria

18 Years - 77 Years (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • Centro Hospitalar de Trás os Montes e Alto Douro

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

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

Arm 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).

Outcomes

Primary Outcome Measures

spleen stiffness measurement (SSM)
Change from baseline in spleen stiffness measurement (SSM) measured by transient elastography (TE) after 24 hour suspension of carvedilol treatment.

Secondary Outcome Measures

liver stiffness measurement (LSM)
Change from baseline in liver stiffness measurement (LSM) measured by transient elastography (TE) after 24 hour suspension of carvedilol treatment.

Full Information

First Posted
August 11, 2023
Last Updated
August 24, 2023
Sponsor
Centro Hospitalar De São João, E.P.E.
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1. Study Identification

Unique Protocol Identification Number
NCT06015373
Brief Title
The Impact of Carvedilol Posology on Clinically Significant Portal Hypertension
Official Title
The Impact of Carvedilol Posology on Clinically Significant Portal Hypertension: Insights From Elastography Measurements
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
June 1, 2023 (Actual)
Primary Completion Date
June 30, 2023 (Actual)
Study Completion Date
July 31, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centro Hospitalar De São João, E.P.E.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Clinically Significant Portal Hypertension
Keywords
portal hypertension, carvedilol, elastography

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patients with CSPH receiving carvedilol twice daily and supress the night dose of carvedilol
Arm Type
Experimental
Arm 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).
Intervention Type
Drug
Intervention Name(s)
supress the night dose of carvedilol
Intervention Description
already described
Primary Outcome Measure Information:
Title
spleen stiffness measurement (SSM)
Description
Change from baseline in spleen stiffness measurement (SSM) measured by transient elastography (TE) after 24 hour suspension of carvedilol treatment.
Time Frame
Baseline SSM measured up to 3 months before enrolment, and measured at 24 hours after suspending carvedilol
Secondary Outcome Measure Information:
Title
liver stiffness measurement (LSM)
Description
Change from baseline in liver stiffness measurement (LSM) measured by transient elastography (TE) after 24 hour suspension of carvedilol treatment.
Time Frame
Baseline LSM measured up to 3 months before enrolment, and measured at 24 hours after suspending carvedilol

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
77 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Centro Hospitalar de Trás os Montes e Alto Douro
City
Vila Real
State/Province
Lordelo
ZIP/Postal Code
5000-508
Country
Portugal

12. IPD Sharing Statement

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The Impact of Carvedilol Posology on Clinically Significant Portal Hypertension

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