Skip to main content
OpenTrials
Completed

NCT Number: NCT06015373

The Impact of Carvedilol Posology on Clinically Significant Portal Hypertension

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Clinically Significant Portal Hypertension Digestive System Diseases Hypertension, Portal Liver Diseases

Age range

18 year–77 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centro Hospitalar de Trás os Montes e Alto Douro

Vila Real, Lordelo, 5000-508, Portugal

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

supress the night dose of carvedilol

Drug

already described

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Centro Hospitalar De São João, E.P.E.

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Aug 29, 2023
Registry last updated
Aug 29, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.