Carvedilol + Simvastatin vs. Carvedilol Alone for Cirrhosis and Cirrhotic Cardiomyopathy and Impact on Hepatic Decompensation and Survival
Key facts
- Where
- Chandigarh, IndiaSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 65 years old?
Source: NCT06431919, who can take part
Where in India
- PGIMER, Department of HepatologyChandigarh, IndiaContact: Prerna Sharma, MScTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Post Graduate Institute of Medical Education and Research, Chandigarh
- Trial code
- NCT06431919
- Record updated
- 8 June 2025
- Original description
Cirrhosis and portal hypertension are associated with a hyperdynamic circulation and decompensation events, including development of ascites, variceal bleeding, acute kidney injury, and susceptibility to infections.Read full original descriptionShow less
Carvedilol + Simvastatin vs. Carvedilol Alone for Chronic Liver Disease and Cirrhotic Cardiomyopathy and Its Impact on Hepatic Decompensation and Survival; a Double-blind Randomized Controlled Trial
Cirrhosis and portal hypertension are associated with a hyperdynamic circulation and decompensation events, including development of ascites, variceal bleeding, acute kidney injury, and susceptibility to infections.
Rationale:
Cirrhosis and portal hypertension are associated with a hyperdynamic circulation and decompensation events, including ascites, variceal bleeding, acute kidney injury, and susceptibility to infections. CCM, present in 30-70% of patients, is characterized by structural and functional abnormalities in the heart, and is associated with progression of cirrhosis, impaired quality of life and poor survival. Statins play a crucial role in reducing proatherogenic LDL cholesterol levels, making them a cornerstone in managing diabetes and cardiovascular diseases (CVDs) with the aim of decreasing or reversing atherosclerosis. This trial aims to evaluate the impact and safety of simvastatin in cirrhotic cardiomyopathy.
Novelty: Simvastatin might be of special value in diastolic dysfunction through its hemodynamic and functional effects on LV remodeling and improve portal hemodynamics through the pleotropic effects of lipophilic statins.
Objectives:
The primary objective is to assess the combined effects of carvedilol and simvastatin in managing CCM vs carvedilol alone for a composite outcome to prevent decompensation and reduce all-cause mortality. We will comprehensively evaluate cardiac function, decompensation events and survival based on impact of simvastatin over the standard betablocker carvedilol.
Methods:
This is a double-blinded randomized placebo-controlled trial involving patients diagnosed with CCM. Clinical data, including cardiac imaging, cardiac biomarkers, and survival outcomes, will be assessed for either group.
Expected Outcome:
The investigators anticipate that the synergistic use of simvastatin and carvedilol will effectively reduce portal pressure, improve portal haemodynamic, and enhance cardiac remodelling. Successful reversal of LVDD can potentially prevent clinical events such as ascites, encephalopathy, and acute kidney injury (AKI).
Inclusion: 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: Patient previously treated with statin (one month before the study); Need for medications, metabolized by CYP3A4(such as amlodipine, verapamil, fenofibrate azole antibiotics, protease inhibitors etc.); Coronary artery disease; Sick sinus syndrome/ Pacemaker, valvular heart disease; Cardiac rhythm disorder, Peripartum cardiomyopathy; Portopulmonary hypertension/ hepatopulmonary syndrome; Patients with HIV or retroviral therapy; Acute variceal bleeding in last 6 months; Serum Creatinine>2 mg/dl; Age >65 years; Contraindications to statins; Advanced Cirrhosis (CTP score>9); Transjugular intrahepatic portosystemic shunt (TIPS) insertion; Hepatocellular carcinoma; Pregnancy or lactation; Anemia Hb < 8gm/dl in females, and < 9 gm/dl in males.