The Impact of Carvedilol Posology on Clinically Significant Portal Hypertension

Sponsor

Centro Hospitalar De São João, E.P.E. (Other)

Overall Status

Completed

CT.gov ID

NCT06015373

Collaborator

(none)

Enrollment

Location

Arm

Actual Duration (Months)

17.2

Patients Per Site Per Month

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Clinically Significant Portal Hypertension	Drug: supress the night dose of carvedilol	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

34 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jun 1, 2023

Actual Primary Completion Date :

Jun 30, 2023

Actual Study Completion Date :

Jul 31, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

spleen stiffness measurement (SSM) [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.

Secondary Outcome Measures

liver stiffness measurement (LSM) [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 77 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Centro Hospitalar de Trás os Montes e Alto Douro	Vila Real	Lordelo	Portugal	5000-508

Sponsors and Collaborators

Centro Hospitalar De São João, E.P.E.

Investigators

None specified.

Study Documents (Full-Text)

More Information

Publications

None provided.

Responsible Party:

Bruno Besteiro, MD, Principal Investigator, Centro Hospitalar De São João, E.P.E.

ClinicalTrials.gov Identifier:

NCT06015373

Other Study ID Numbers:

LHU-2023-001

First Posted:

Aug 29, 2023

Last Update Posted:

Aug 29, 2023

Last Verified:

Aug 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Bruno Besteiro, MD, Principal Investigator, Centro Hospitalar De São João, E.P.E.

portal hypertension

carvedilol

elastography

Additional relevant MeSH terms:

Hypertension, Portal

Hypertension

Carvedilol

Study Results

No Results Posted as of Aug 29, 2023