Actively Recruiting
Carvedilol and Simvastatin for Chronic Liver Disease and Cirrhotic Cardiomyopathy Impacting Hepatic Decompensation and Survival in a Randomized Controlled Trial
Led by Post Graduate Institute of Medical Education and Research, Chandigarh · Updated on 2025-06-08
260
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
P
Post Graduate Institute of Medical Education and Research, Chandigarh
Lead Sponsor
I
Indian Council of Medical Research
Collaborating Sponsor
AI-Summary
What this Trial Is About
Cirrhosis and portal hypertension often lead to complications like ascites, variceal bleeding, acute kidney injury, and infections. Cirrhotic cardiomyopathy (CCM), affecting 30-70% of these patients, involves structural and functional heart changes and is linked to worsening cirrhosis, lower quality of life, and higher mortality. This trial studies the effects and safety of simvastatin, in combination with carvedilol, compared to carvedilol alone, on CCM and related complications in a controlled, randomized setting. Participants receive either simvastatin 20 mg daily plus carvedilol starting at 3.125 mg twice daily (adjusted weekly to reach a target heart rate) along with standard medical therapy, or carvedilol with standard therapy alone. The study is double-blinded and placebo-controlled, assessing the combined effects of these drugs on cardiac remodeling, portal blood flow, and prevention of liver decompensation events. Treatment and monitoring occur over a one-year period. During the study, participants undergo comprehensive cardiac evaluations including imaging and biomarker tests, along with clinical monitoring for liver-related complications and survival outcomes. The primary measure is time to acute decompensation within one year, with secondary outcomes including all-cause mortality, hospitalization episodes, cardiac function improvement, and inflammatory markers. This process will provide detailed data on how simvastatin may impact CCM and liver disease progression over the study duration.
CONDITIONS
Brief Title
Carvedilol + Simvastatin vs. Carvedilol Alone for Cirrhosis and Cirrhotic Cardiomyopathy and Impact on Hepatic Decompensation and Survival
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age range of 18-65 years
- Diagnosed compensated cirrhosis by histology or clinical, lab, and ultrasound findings
- Cirrhotic cardiomyopathy with ejection fraction greater than 50% confirmed by 2D echocardiography with tissue Doppler imaging
- Provided written informed consent
You will not qualify if you...
- Age over 65 years
- Serum creatinine greater than 2 mg/dl
- Prior statin treatment within one month before the study
- Contraindications to statin use
- Advanced cirrhosis with Child-Pugh score over 9
- Presence of coronary artery disease
- Sick sinus syndrome, pacemaker, or valvular heart disease
- Cardiac rhythm disorders or peripartum cardiomyopathy
- Portopulmonary hypertension or hepatopulmonary syndrome
- History of transjugular intrahepatic portosystemic shunt (TIPS) insertion
- Hepatocellular carcinoma
- Pregnancy or breastfeeding
- HIV infection or receiving retroviral therapy
- Anemia with hemoglobin less than 8 gm/dl in females or less than 9 gm/dl in males
- Acute variceal bleeding within the last 6 months
- Use of medications metabolized by CYP3A4 such as amlodipine, verapamil, fenofibrate, azole antibiotics, or protease inhibitors
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 1 year
Participants receive either Simvastatin combined with Carvedilol or Carvedilol alone to manage cirrhotic cardiomyopathy and reduce hepatic decompensation and mortality risk.
Regular visits during treatment to adjust medication doses and monitor health
Duration - Up to 1 year from enrollment
Participants are monitored for survival, decompensation events, cardiac function, and biomarker levels after treatment.
Periodic assessments during follow-up
Trial Site Locations
Total: 1 location
1
PGIMER, Department of Hepatology
Chandigarh, India, 160012
Actively Recruiting
Research Team
D
Dr Madhumita Premkumar, DM
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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