Clinically Significant Portal Hypertension
Conditions
Keywords
portal hypertension, carvedilol, elastography
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).
Interventions
DRUGsupress the night dose of carvedilol
already described
Sponsors
Centro Hospitalar De São João, E.P.E.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 77 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Portugal
Outcome results
None listed