Carvedilol + Simvastatin vs. Carvedilol Alone for Cirrhosis and Cirrhotic Cardiomyopathy and Impact on Hepatic Decompensation and Survival

Launched by POST GRADUATE INSTITUTE OF MEDICAL EDUCATION AND RESEARCH, CHANDIGARH · May 22, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the effects of combining two medications, carvedilol and simvastatin, to see if they can help patients with cirrhotic cardiomyopathy (CCM), a condition that affects the heart and is common in people with liver cirrhosis. The goal is to find out if this combination can prevent serious complications related to cirrhosis, such as fluid buildup in the abdomen, kidney problems, and even improve overall survival rates. Participants will be monitored for changes in heart function and any related health events.

To be eligible for this trial, participants should be between 18 and 65 years old, have compensated cirrhosis, and be diagnosed with CCM based on specific heart imaging tests. They will need to provide informed consent to join the study. Those who are older than 65, have certain heart or liver conditions, or are pregnant will not be able to participate. If you join the trial, you can expect regular check-ups, heart imaging, and assessments of your overall health throughout the study. This research could offer new insights into treating heart issues in patients with liver disease.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age range of 18-65 years
• • Compensated cirrhosis, as diagnosed by histology or clinical, laboratory and USG findings,
• • CCM (with EF\>50%) on 2D echocardiography with TDI
• • Written informed consent.
• Exclusion Criteria:
• • Age \>65 years
• • Serum Creatinine\>2 mg/dl
• • Patient previously treated with statin (one month before the study)
• • Contraindications to statins
• • Advanced Cirrhosis (CTP score\>9)
• • Coronary artery disease
• • Sick sinus syndrome/ Pacemaker, valvular heart disease
• • Cardiac rhythm disorder, Peripartum cardiomyopathy
• • Portopulmonary hypertension/ hepatopulmonary syndrome
• • Transjugular intrahepatic portosystemic shunt (TIPS) insertion
• • Hepatocellular carcinoma
• • Pregnancy or lactation
• • Patients with HIV or retroviral therapy
• • Anemia Hb \< 8gm/dl in females, and \< 9 gm/dl in males
• • Acute variceal bleeding in last 6 months.
• • Need for medications, metabolized by CYP3A4(such as amlodipine, verapamil, fenofibrate azole antibiotics, protease inhibitors etc.)