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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| supress the night dose of carvedilol | Drug | already described |
|
| Measure | Description | Time Frame |
|---|---|---|
| spleen stiffness measurement (SSM) | Change from baseline in spleen stiffness measurement (SSM) measured by transient elastography (TE) after 24 hour suspension of carvedilol treatment. | Baseline SSM measured up to 3 months before enrolment, and measured at 24 hours after suspending carvedilol |
| Measure | Description | Time Frame |
|---|---|---|
| liver stiffness measurement (LSM) | Change from baseline in liver stiffness measurement (LSM) measured by transient elastography (TE) after 24 hour suspension of carvedilol treatment. | Baseline LSM measured up to 3 months before enrolment, and measured at 24 hours after suspending carvedilol |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centro Hospitalar de TrĂ¡s os Montes e Alto Douro | Vila Real | Lordelo | 5000-508 | Portugal |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 31, 2023 | Aug 24, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 31, 2023 | Aug 24, 2023 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D006975 | Hypertension, Portal |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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