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CTRI Number  CTRI/2025/01/079397 [Registered on: 24/01/2025] Trial Registered Prospectively
Last Modified On: 27/12/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Treatment of Cirrhotic cardiomyopathy with Carvedilol+ Simvastatin vs. Carvedilol + placebo  
Scientific Title of Study   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. 
Trial Acronym  CIRROSTAT Trial 
Secondary IDs if Any  
Secondary ID  Identifier 
NCT06431919  ClinicalTrials.gov 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Madhumita Premkumar 
Designation  Associate Professor 
Affiliation  Post Graduate Institute of Medical Education & Research, Chandigarh 
Address  Room Number 32 Ground Floor Nehru Hospital Extension PGIMER Chandigarh

Chandigarh
CHANDIGARH
160012
India 
Phone  01722754777  
Fax    
Email  drmadhumitap@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Madhumita Premkumar 
Designation  Associate Professor 
Affiliation  Post Graduate Institute of Medical Education & Research, Chandigarh 
Address  Room Number 32 Ground Floor Nehru Hospital Extension PGIMER Chandigarh

Chandigarh
CHANDIGARH
160012
India 
Phone  01722754777  
Fax    
Email  drmadhumitap@gmail.com  
 
Details of Contact Person
Public Query  
Name  Prerna Sharma 
Designation  Project Scientist - I 
Affiliation  Post Graduate Institute of Medical Education & Research, Chandigarh 
Address  Room Number 55 Ground Floor Nehru Hospital Extension PGIMER Chandigarh

Chandigarh
CHANDIGARH
160012
India 
Phone  01722754777  
Fax    
Email  perusharma96@gmail.com  
 
Source of Monetary or Material Support  
Indian Council of Medical Research New Delhi India Pin Code 110029 
 
Primary Sponsor  
Name  Indian Council of Medical Research 
Address  NEW DELHI INDIA PIN CODE 110029 
Type of Sponsor  Government funding agency 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Drm Madhumita Premkumar  PGIMER-Department of Hepatology  Sector 12 Chandigarh
Chandigarh
CHANDIGARH 		 01722754777

drmadhumitap@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K740||Hepatic fibrosis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Active Comparator: Carvedilol arm   Carvedilol: Starting dose of 3.125 mg twice daily targeted upwards q 7 days to achieve target heart rate oraly for one year Standard Medical Therapy  
Intervention  Experimental: Simvastatin + Carvedilol-arm  Simvastatin fixed dose of 20 mg per day Orally for one year Carvedilol: Starting dose of 3.125 mg twice daily targeted upwards q 7 days to achieve target heart rate Orally for one year Standard Medical Therapy  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Age range of 18 to 65 years

Compensated cirrhosis as diagnosed by histology or clinical laboratory and USG findings

CCM with EF less than 50 percent on 2D echocardiography with TDI

Written informed consent  
 
ExclusionCriteria 
Details  Age more than 65 years

Serum Creatinine more than 2 mg per dl

Patient previously treated with statin one month before the study

Contraindications to statins

Advanced Cirrhosis CTP score more than 9 or Child C will be excluded

Coronary artery disease

Sick sinus syndrome Pacemaker valvular heart disease

Cardiac rhythm disorder Peripartum cardiomyopathy

Portopulmonary hypertension hepatopulmonary syndrome

Transjugular intrahepatic porto systemic shunt TIPS insertion

Hepatocellular carcinoma

Pregnancy or lactation

Patients with HIV or retroviral therapy

Anemia Hb less than 8gm per dl in females and less than 9 gm per 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  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
The primary outcome measure is defined as a composite end point of acute decompensation event (acute variceal bleeding, new ascites or recurrence of previously controlled ascites, episode of hepatic encephalopathy or acute kidney injury), death in the participants.   At 1 year from enrolment  
 
Secondary Outcome  
Outcome  TimePoints 
Improvement in cirrhotic cardiomyopathy parameters (left ventricular diastolic function) in either arm based on Echocardiography and Cardiac Imaging.   1 YEAR 
Any episodes which warranted hospitalization of the participants.   1 YEAR 
Serum level of BNP and other cardiac and inflammatory biomarkers will be assessed and correlated clinically.  1 YEAR 
 
Target Sample Size   Total Sample Size="260"
Sample Size from India="260" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 3/ Phase 4 
Date of First Enrollment (India)   31/01/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Cirrhosis and portal hypertension are associated with 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 hyperdynamic circulation and decompensation events, including ascites, variceal bleeding, acute kidney injury, and susceptibility to infections. CCM, present in 25-30 % 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. 

 

 
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