Propranolol, Carvedilol and Rosuvastatin in the Prevention of Variceal Bleeding in Cirrhotic Portal Hypertension
NCT ID: NCT03720067
Last Updated: 2019-05-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2/PHASE3
80 participants
INTERVENTIONAL
2019-01-25
2022-12-20
Brief Summary
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Surrogate serum markers of portal hypertension will be evaluated and correlated to HVPG values and to its variations.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Phase 1: Propranolol (PPL)
Hepatic venous pressure gradient (HVPG) will be measured before and after 120 minutes of a loading dose of Propranolol (PPL) 80 mg PO. Thereafter, patients will receive maintenance therapy with Propranolol (40 to 320 mg / day) adjusted according to blood pressure and heart rate. After 28 days of reaching the maximum tolerated dose, a new HVPG measurement will be performed.
Propranolol
40mg to 320mg / day
Phase 1: Carvedilol (CVD)
HVPG will be measured before and after 120 minutes of a loading dose of Carvedilol (CVD) 12.5 mg PO. Thereafter, patients will receive maintenance therapy with Carvedilol (6.25 - 25 mg / day) adjusted according to blood pressure. After 28 days of reaching the maximum tolerated dose, a new HVPG measurement will be performed.
Carvedilol
6.25mg to 25mg / day
Phase 2: PPL non-responders/rosuvastatin
Patients treated with PROPRANOLOL (PPL) who do not reach HVPG fall below 12 mmHg will be randomized to receive the addition of ROSUVASTATIN 20 mg /day PO. HVPG will be measured again after 56 days.
Propranolol
40mg to 320mg / day
Rosuvastatin
20mg / day
Phase 2: PPL non-responders/placebo
Patients treated with PROPRANOLOL (PPL) who do not reach HVPG fall below 12 mmHg will be randomized to receive the addition of PLACEBO 1 tablet PO. HVPG will be measured again after 56 days.
Propranolol
40mg to 320mg / day
Placebo
Placebo of rosuvastatin
Phase 2: CVD non-responders/rosuvastatin
Patients treated with CARVEDILOL (CVD) who do not reach HVPG fall below 12 mmHg will be randomized to receive the addition of ROSUVASTATIN 20 mg /day PO. HVPG will be measured again after 56 days.
Carvedilol
6.25mg to 25mg / day
Rosuvastatin
20mg / day
Phase 2: CVD non-responders/placebo
Patients treated with CARVEDILOL (CVD) who do not reach HVPG fall below 12 mmHg will be randomized to receive the addition of PLACEBO 1 tablet PO. HVPG will be measured again after 56 days.
Carvedilol
6.25mg to 25mg / day
Placebo
Placebo of rosuvastatin
Interventions
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Propranolol
40mg to 320mg / day
Carvedilol
6.25mg to 25mg / day
Rosuvastatin
20mg / day
Placebo
Placebo of rosuvastatin
Eligibility Criteria
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Inclusion Criteria
* Previous variceal bleeding
* Endoscopic variceal eradication at least 2 weeks before
Exclusion Criteria
* Model for End-Stage Liver Disease (MELD) score \> 25
* Child-Pugh score \> 13
* HVPG ≤ 12 mmHg
* Creatinine clearance \< 50 mL/min
* Refractory ascites
* Hepatic encephalopathy stages 3 or 4
* Alcohol use in the last 6 months
* Hepatitis C treatment in the last 6 months
* Changing or initiating a new hepatitis B treatment in the last 6 months
* Malignant neoplasms from any origin except basal cell carcinoma
* HIV infection
* Pregnancy
* Anticoagulation
* Recent or complete portal vein thrombosis
18 Years
ALL
No
Sponsors
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Universidade Federal do Rio de Janeiro
OTHER
Responsible Party
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Guilherme Rezende
Associated Professor
Locations
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Universidade Federal do Rio de Janeiro
Rio de Janeiro, , Brazil
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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83211318.1.0000.5257
Identifier Type: -
Identifier Source: org_study_id
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