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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
India
PGIMER, Department of Hepatology
RECRUITING
Chandigarh
Contact Information
Primary
Dr Madhumita Premkumar, DM
drmadhumitap@gmail.com
7087003409
Time Frame
Start Date: 2025-06-10
Estimated Completion Date: 2028-02
Participants
Target number of participants: 260
Treatments
Experimental: Experimental: Simvastatin + Carvedilol-arm
* Simvastatin fixed dose of 20 mg per day~* Carvedilol: Starting dose of 3.125 mg twice daily targeted upwards q 7 days to achieve target heart rate~* Standard Medical Therapy
Active_comparator: Active Comparator: Carvedilol arm
* Carvedilol: Starting dose of 3.125 mg twice daily targeted upwards q 7 days to achieve target heart rate~* Standard Medical Therapy
Sponsors
Collaborators: Indian Council of Medical Research
Leads: Post Graduate Institute of Medical Education and Research, Chandigarh

This content was sourced from clinicaltrials.gov