Pentoxifylline Plus Carvedilol vs Carvedilol Monotherapy in Preventing New Decompensation in Stable Cirrhotic Patients With Prior Decompensation

• Status: Not yet recruiting
• Trial end date: 2024-08-31
• Target enrollment: 0
• Participant gender: All

Summary

Cirrhotics with decompensation have increased risk of morbidity and mortality. There is increased portal pressure leading to decompensation. Carvedilol is a standard therapy given to cirrhotic patient with clinically significant portal hypertension to reduce portal pressure. Pentoxifylline is a nonspecific phosphodiesterase inhibitor with anti-inflammatory properties. It reduces portal hypertension, decreases lipopolysaccharide-induced liver injury, improves nonalcoholic steatohepatitis, prevents development of HRS in ascites and SAH, prevents hepatopulmonary syndrome. Investigator want to study whether addition of pentoxifylline to carvediolol vs carvedilol monotherapy reduces the risk of mortality and further decompensation in cirrhotics with prior decompensation.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Institute of Liver and Biliary Sciences, India
• Treatments: Carvedilol; Pentoxifylline

Criteria

Inclusion Criteria:

1. Age 18-70 years

2. Cirrhosis with prior clinical decompensation (ascites, Hepatic encephalopathy, Portal Hypertension related bleed)

3. No current clinical decompensation (for at least 3 months)

Exclusion Criteria:

1. Post TIPS/ BRTO/ SAE patients

2. Post renal or liver transplantation

3. History of CAD, ischemic cardiomyopathy, PVD, ventricular arrythmia

4. Presence of clinical ascites, HE, Jaundice

5. Last clinical decompensation within 3 months.

6. Ongoing significant alcohol use

7. Active HCV/HBV infection (Detectable HCV RNA/ HBV DNA)

8. Prior Intolerance to carvedilol and hypersensitivity to Pentoxyfylline

9. Use of Pentoxifylline within last 1 month

10. AIH/PBC

11. Lack of informed consent

12. Hepatocellular carcinoma / Portal vein thrombosis/ Budd Chiari Syndrome

13. Non-cirrhotic portal hypertension

14. Ongoing CAM/Hepatotoxic drug intake

15. Known HIV infection

16. Pregnant women

17. HepatoPulmonary Syndrome