Carvedilol plus simvastatin versus carvedilol alone for cirrhosis-related heart dysfunction

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized interventional comparison of carvedilol alone versus carvedilol plus simvastatin 20 mg in adults 18–65 with compensated cirrhosis and cirrhotic cardiomyopathy (EF >50%) conducted at PGIMER Chandigarh. Participants receive carvedilol (3.125 mg) with or without simvastatin and are followed for hepatic decompensation events, cardiac function, renal outcomes, adverse effects, and survival. Major exclusions include advanced cirrhosis (Child-Pugh >9), significant renal dysfunction, recent statin use, coronary artery disease, and other contraindications to statins. The trial emphasizes clinical endpoints (decompensation and survival) and safety monitoring of statin therapy in chronic liver disease.

Why it matters

Who can join: the full rules

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.)

Where it's running

• PGIMER, Department of Hepatology
  Chandigarh, India Recruiting

Study contacts

• Principal investigator: Dr Madhumita Premkumar, DM — Post Graduate Institute of Medical Education and Research, Chandigarh
• Study coordinator: Dr Madhumita Premkumar, DM
• Email: drmadhumitap@gmail.com
• Phone: 7087003409

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.