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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-31

Study Completion Date

2018-02-28

Brief Summary

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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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Detailed Description

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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.

Conditions

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Portal Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Simvastatin

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

Group Type ACTIVE_COMPARATOR

Simvastatin

Intervention Type DRUG

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

no treatment

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Simvastatin

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

Intervention Type DRUG

Other Intervention Names

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Corvast

Eligibility Criteria

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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

Eligible Sex

ALL

Accepts Healthy Volunteers

No