Health Condition 1: K740- Hepatic fibrosis
Conditions
Interventions
Intervention1: Carvedilol tablets (oral): Starting: 6.25 mg once daily, Titration to 6.25 mg twice daily if tolerated Follow up of 12 months per participant
Control Intervention1: Placebo Oral: 6.25
Sponsors
Dr. Manoranjan Swain
Eligibility
Inclusion criteria
Inclusion criteria: Age 18 75 years Compensated cirrhosis diagnosed by clinical, biochemical, imaging/elastography No prior decompensation (ascites, variceal bleed, jaundice, encephalopathy ) No esophageal varices on baseline endoscopy (within 4 weeks) SBP greater or equal to 90 mmHg, HR greater or equal to 60 bpm Written informed consent
Exclusion criteria
Exclusion criteria: Current decompensation Varices on baseline endoscopy Use of beta-blockers or nitrates Severe bradycardia or hypotension Asthma or COPD CKD stage greater or equal to 3, creatinine greater or equal to 1.5 mg/dL Child-Pugh score greater than8 Pregnancy or lactation Known hypersensitivity to carvedilol HCC or portal vein thrombosis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of newly developed esophageal varices confirmed on upper GI endoscopy at 12 monthsTimepoint: Endoscopy at 0, 6 and 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to development of esophageal varices (months) Change in liver disease severity (clinical, biochemical, imaging) Occurrence of portal hypertension-related events (ascites, GI bleed, SBP) Safety and tolerability of carvedilol (adverse events, discontinuation) All-cause mortality during follow-upTimepoint: follow-up visits at 2 weeks and 4 weeks and at 3, 6, and 12 months | — |
Countries
India
Contacts
Public ContactDr Tryambak Samanta
Medical College, Kolkata
Outcome results
None listed