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Effect if Simvastatin (Drug) in Liver Cirrhosis

To Study the Safety and Efficacy of Simvastatin in Patients With Hepatopulmonary Syndrome in Cirrhosis- A Double Blind Randomized Controlled Trial-Superiority Trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/12/038917
Enrollment
45
Registered
2021-12-24
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K746- Other and unspecified cirrhosis ofliver

Interventions

Intervention1: Simvastatin with SMT: Simvastatin 40 mg once daily orally Duration: 6 months Standard Medical Treatment Control Intervention1: Placebo with SMT: Placebo with Standard Medical Treatment

Sponsors

Institute of Liver and Biliary Sciences
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1) Diagnosed case of Hepato-pulmonary syndrome AaPO2 > 15 mm Hg on standing room air arterial blood gas (ABG). PaO2 2) Child A/B cirrhosis, Child C with CTP score of more than equals to 10 3) Patient with no liver transplant option

Exclusion criteria

Exclusion criteria: 1) Child-C cirrhosis CTP >10 2) Very Severe HPS 3) Acute-on-chronic liver failure 4) Thrombosis of splenoportal axis 5) Hepatocellular carcinoma 6) Renal dysfunction 7) Patients intolerant to beta blockers (history of hypotension or bradycardia) 8) Contraindication for beta-blockers (history of chronic obstructive pulmonary disease, atrioventricular block) 9) Pregnant females 10) Refusal to participate in the study 11) Hepatic Hydrothorax

Design outcomes

Primary

MeasureTime frame
Achievement of complete response by the end of 6 monthsTimepoint: 6 months

Secondary

MeasureTime frame
Development of serious adverse effects leading to withdrawal of the drug or death from any causeTimepoint: 2 years;Severity of Liver DiseaseTimepoint: 6 months;Transplant free survivalTimepoint: 3 and 6 months

Countries

India

Contacts

Public ContactDr Shiv Kumar Sarin

Institute of Liver and Biliary Sciences

shivsarin@gmail.com

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026