Health Condition 1: K740- Hepatic fibrosis
Conditions
Interventions
Intervention1: carvedilol + atorvastatin: asfasfa
Intervention2: carvedilol and atorvastatin: patients will receive both carvedilol and atorvastatin for a total of 6 months
Control Intervention1: carv
Sponsors
PGIMER CHANDIGARH
Eligibility
Inclusion criteria
Inclusion criteria: Age 18 to 75 years Compensated cirrhosis Child Pugh class A with CSPH diagnosed invasively by presence of varices or ruled in non-invasively as defined by Baveno VII Patients should have stable liver disease Patients with chronic hepatitis C should have attained sustained virologic response Patients with chronic hepatitis B should be on antivirals with documented virological suppression defined as HBV DNA less than lower limit of detection. Patients with alcohol related cirrhosis with alcohol abstinence for at least 3 months Patients with autoimmune hepatitis should be on immunosuppression, on stable dose, with transaminases less than 1.5 times ULN with no episode of biochemical flare in last 6 months Patients fit to give informed consent
Exclusion criteria
Exclusion criteria: Patients with decompensated cirrhosis Child Pugh B or C Patients with presence of portal vein thrombosis Patients with hepatocellular carcinoma , or any other malignancy Patients with end-stage renal disease Patients with active alcohol intake greater than 20 gm per day for women, greater than 30 g per day for men or a history of alcohol consumption in the last 3 months Patients with Hepatitis B or C with viral load detectable Patients with uncontrolled diabetes mellitus or hypertension Patients with any known contraindication to carvedilol or atorvastatin such as bradycardia less than 55 bpm, hypotension systolic bp less than 90 mm hg, myopathy, or prior statin intolerance Patients receiving current or recent statin therapy or NSBB within 3 months Pregnant or lactating women Patients with severe systemic illness that could confound outcome assessment Those unable or unwilling to provide consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of hemodynamic responders, defined as patients achieving either: a greater than or equal to 20% reduction in SSM from baseline, and/or disappearance of esophageal varices at 6 months of follow-up. Timepoint: 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in SSM and LSM from baseline to 6 months. Change in status of esophageal varices at 6 months compared to baseline. To assess for change in liver function parameters (serum bilirubin, AST, ALT, ALP, albumin) and platelet count from baseline to 6 months. Incidence of upper gastrointestinal bleeding and/or other hepatic decompensation events during the study period. Incidence and severity of adverse effects Timepoint: 6 months | — |
Countries
India
Contacts
Public ContactNaveen Bhagat
PGIMER CHANDIGARH
Outcome results
None listed