The Impact of Carvedilol Posology on Clinically Significant Portal Hypertension
- Conditions
- Clinically Significant Portal Hypertension
- Interventions
- Drug: supress the night dose of carvedilol
- Registration Number
- NCT06015373
- Lead Sponsor
- Centro Hospitalar De São João, E.P.E.
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 34
- patients with CSPH (defined as a LSM 25 kPa or SSM over 45kPa prior to introduction of carvedilol)
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Patients with CSPH receiving carvedilol twice daily and supress the night dose of carvedilol 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).
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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.
Trial Locations
- Locations (1)
Centro Hospitalar de Trás os Montes e Alto Douro
🇵🇹Vila Real, Lordelo, Portugal
Centro Hospitalar de Trás os Montes e Alto Douro🇵🇹Vila Real, Lordelo, Portugal