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

Last updated: May 12, 2019
Sponsor: Universidade Federal do Rio de Janeiro
Overall Status: Active - Recruiting

Phase

2/3

Condition

Diabetes And Hypertension

Hemorrhage

Liver Disorders

Treatment

N/A

Clinical Study ID

NCT03720067
83211318.1.0000.5257
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Hepatic cirrhosis of any etiology

  • Previous variceal bleeding

  • Endoscopic variceal eradication at least 2 weeks before

Exclusion

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

Study Design

Total Participants: 80
Study Start date:
January 25, 2019
Estimated Completion Date:
December 20, 2022

Connect with a study center

  • Universidade Federal do Rio de Janeiro

    Rio de Janeiro,
    Brazil

    Active - Recruiting

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