Clinically Significant Portal HypertensionNCT06015373
The Impact of Carvedilol Posology on Clinically Significant Portal Hypertension
A study testing supress the night dose of carvedilol in people with Clinically Significant Portal Hypertension, run by Centro Hospitalar De São João, E.P.E. at 1 site in Portugal.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 77 yearsHealthy volunteers can take part
- Conditions the study is for
- Clinically Significant Portal Hypertension
- What is being tested?
- supress the night dose of carvedilol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 sitePortugal
- Study dates
- 1 Jun 2023to 31 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 77 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- patients with CSPH (defined as a LSM 25 kPa or SSM over 45kPa prior to introduction of carvedilol)
Who cannot join
- 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
Show all 9Show fewer
- Portal venous thrombosis
- Refusal to participate in the study
- Failure to comply to the study regimen
Trial locations and contacts
1 site in 1 country.
Portugal1 site
Centro Hospitalar de Trás os Montes e Alto Douro
Vila Real, Lordelo, 5000-508
About this study
Official title: The Impact of Carvedilol Posology on Clinically Significant Portal Hypertension: Insights From Elastography Measurements
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).
- Being tested
- supress the night dose of carvedilol
- Keywords
- portal hypertension, carvedilol, elastography
- Medical subject headings
- Hypertension, Portal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
supress the night dose of carvedilolDrug
already described
| Study group | Role | What they receive |
|---|---|---|
| Patients with CSPH receiving carvedilol twice daily and supress the night dose of carvedilol | Experimental | 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). Receives: Drug: supress the night dose of carvedilol |
What is being measured
The primary outcome is the main question the study is designed to answer.
spleen stiffness measurement (SSM)
Change from baseline in spleen stiffness measurement (SSM) measured by transient elastography (TE) after 24 hour suspension of carvedilol treatment.
Measured: Baseline SSM measured up to 3 months before enrolment, and measured at 24 hours after suspending carvedilol
Secondary outcomes (1)
liver stiffness measurement (LSM)
Change from baseline in liver stiffness measurement (LSM) measured by transient elastography (TE) after 24 hour suspension of carvedilol treatment.
Measured: Baseline LSM measured up to 3 months before enrolment, and measured at 24 hours after suspending carvedilol
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2023
- Study start1 Jun 2023
- Primary completion30 Jun 2023
- Study completion31 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clinically Significant Portal HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centro Hospitalar De São João, E.P.E.
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bruno Besteiro, Centro Hospitalar De São João, E.P.E.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06015373
- Sponsor's protocol ID
- LHU-2023-001
- Status last verified
- Aug 2023
- First submitted
- 11 Aug 2023
- Last updated
- 29 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Carvedilol Posology on Clinically Significant Portal Hypertension: Insights From Elastography Measurements
- ClinicalTrials.gov ID
- NCT06015373
- Acronym / sponsor ID
- LHU-2023-001
- Keywords
- portal hypertension, carvedilol, elastography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Centro Hospitalar De São João, E.P.E.University, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 31 Jul 2023 (actual)
- First posted
- 29 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with CSPH receiving carvedilol twice daily and supress the night dose of carvedilol | Experimental | Drug: supress the night dose of carvedilolIn 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). |
Who may qualify
- Ages
- 18 to 77 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients with CSPH (defined as a LSM 25 kPa or SSM over 45kPa prior to introduction of carvedilol)
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| supress the night dose of carvedilolalready described | Drug | Patients with CSPH receiving carvedilol twice daily and supress the night dose of carvedilol |
Primary outcome
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.
1 secondary outcome
liver stiffness measurement (LSM)
Time frame: Baseline LSM measured up to 3 months before enrolment, and measured at 24 hours after suspending carvedilol
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing supress the night dose of carvedilol in people with Clinically Significant Portal Hypertension, run by Centro Hospitalar De São João, E.P.E. at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
spleen stiffness measurement (SSM) (time frame: Baseline SSM measured up to 3 months before enrolment, and measured at 24 hours after suspending carvedilol). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2023.