Evaluation Of The Portal Pressure By Doppler Ultrasound In Cirrhotic Patients Before And After Simvastatin

Portal hypertension is not a disease in itself. Rather, it is an indication of an illness, caused mostly by chronic lesions of the liver because of distinct causes, such as viral infection, chronic alcoholism, or metabolic disorders. Other reasons include splanchnic vascular diseases (for example, obstruction of the portal or the hepatic veins). Portal hypertension is defined as a pressure in the portal vein exceeding the vena cava pressure by more than 5 mm Hg.

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Key information

Conditions

Portal Hypertension Digestive System Diseases Hypertension, Portal Liver Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Sherief Abd-Elsalam

Tanta, Egypt

About this study

Indeed, use of simvastatin might attenuate liver fibrosis in patients with chronic C infection, it may also reduce hepatic vascular resistance and portal pressure by improving liver generation of nitric oxide and hepatic endothelial dysfunction in patients with cirrhosis, so it could be an effective therapy for portal hypertension. It might even improve survival of patients with cirrhosis after variceal bleeding.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Positive diagnosis of cirrhosis by US (coarse echogenic pattern, bulky caudate lobe, attenuated hepatic veins)
Clinical manifestations of portal hypertension (as esophageal varices ,splenomegaly, ascites and encephalopathy grade I-II)

Exclusion criteria

Pregnancy
Hepatic encephalopathy grade III-IV
Hepatocellular carcinoma
Treatment with statins in the previous 3 months
Hypersensitivity to statins
Previous surgical shunt or TIPS
Treatment with calcium channel blockers

Treatment and study plan

simvastatin

Drug

Simvastatin 20 mg/day for two weeks (increased to 40 mg/day at day 15) for another two weeks plus the routine treatment

Other names: Corvast

Primary outcomes

Number of Patients with Reduced Portal Pressure After Intervention

Time frame: 6 Months

the number of Patients with Reduced Portal Pressure After Intervention

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Important dates

Study start: 2016
Primary completion: 2018
Study completion: 2018
First posted: Dec 15, 2016
Registry last updated: Mar 8, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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