Patients with hepatic cirrhosis and previous variceal bleeding will be randomly assigned to use propranolol or carvedilol. After 8 weeks, rosuvastatin or placebo will be blindly added to nonresponders (HVPG measurement \> 12mmHg) for another 8 weeks and hemodynamic response will be assessed again. Surrogate serum markers of portal hypertension will be evaluated and correlated to HVPG values and to its variations.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
80
40mg to 320mg / day
6.25mg to 25mg / day
20mg / day
Placebo of rosuvastatin
Universidade Federal do Rio de Janeiro
Rio de Janeiro, Brazil
RECRUITINGAcute hemodynamic response
A decrease in HVPG to 12 mmHg or lower
Time frame: Two hours after a load dose of carvedilol or propranolol
Full hemodynamic response to beta blockers
A decrease in HVPG to 12 mmHg or lower
Time frame: Eight weeks of carvedilol or propranolol
Full hemodynamic response to beta blockers plus rosuvastatin or placebo
A decrease in HVPG to 12 mmHg or lower
Time frame: Eight weeks of beta blockers plus rosuvastatin or placebo
Sufficient hemodynamic response to beta blockers plus rosuvastatin or placebo
A decrease in HVPG of at least 20% from baseline
Time frame: Eight weeks of beta blockers plus rosuvastatin or placebo
Partial hemodynamic response to beta blockers plus rosuvastatin or placebo
A decrease in HVPG of at least 10% from baseline
Time frame: Eight weeks of beta blockers plus rosuvastatin or placebo
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