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

Cirrhosis Clinical Trial

— Betastatin  

Official title:

Propranolol, Carvedilol and Rosuvastatin in the Prevention of Recurrent Variceal Haemorrhage in Patients With Cirrhotic Portal Hypertension

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03720067
• Other study ID #: 83211318.1.0000.5257
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: January 25, 2019
• Est. completion date: December 20, 2022

Study information

• Verified date: May 2019
• Source: Universidade Federal do Rio de Janeiro
• Contact: Guilherme FM Rezende, MD, PhD
• Phone: (5521)999976292
• Email: guimottarezende[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 20, 2022
• Est. primary completion date: December 20, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cirrhosis
• Hemorrhage
• Hypertension
• Hypertension, Portal
• Portal Hypertension
• Variceal Hemorrhage

Intervention

Drug:
• Propranolol
40mg to 320mg / day
• Carvedilol
6.25mg to 25mg / day
• Rosuvastatin
20mg / day
• Placebo
Placebo of rosuvastatin

Locations

Country	Name	City	State
Brazil	Universidade Federal do Rio de Janeiro	Rio de Janeiro

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Federal do Rio de Janeiro

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acute hemodynamic response	A decrease in HVPG to 12 mmHg or lower	Two hours after a load dose of carvedilol or propranolol
Primary	Full hemodynamic response to beta blockers	A decrease in HVPG to 12 mmHg or lower	Eight weeks of carvedilol or propranolol
Primary	Full hemodynamic response to beta blockers plus rosuvastatin or placebo	A decrease in HVPG to 12 mmHg or lower	Eight weeks of beta blockers plus rosuvastatin or placebo
Secondary	Sufficient hemodynamic response to beta blockers plus rosuvastatin or placebo	A decrease in HVPG of at least 20% from baseline	Eight weeks of beta blockers plus rosuvastatin or placebo
Secondary	Partial hemodynamic response to beta blockers plus rosuvastatin or placebo	A decrease in HVPG of at least 10% from baseline	Eight weeks of beta blockers plus rosuvastatin or placebo