Propranolol, Carvedilol and Rosuvastatin in the Prevention of Variceal Bleeding in Cirrhotic Portal Hypertension

• Status: Recruiting
• Trial end date: 2022-12-20
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Universidade Federal do Rio de Janeiro
• Treatments: Carvedilol; Propranolol; Rosuvastatin Calcium

Criteria

Inclusion Criteria:

• Hepatic cirrhosis of any etiology

• Previous variceal bleeding

• Endoscopic variceal eradication at least 2 weeks before

Exclusion Criteria:

• Beta blocker or statin contraindications

• 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