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

Phase 4

Completed

• Conditions: Portal Hypertension
• Interventions: Drug: Simvastatin

• Registration Number: NCT02994485
• Lead Sponsor: Tanta University

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2016-10
• Study First Submitted: 2016-12-13
• Study First Submitted QC: 2016-12-14
• Study First Posted: 2016-12-15
• Primary Completion: 2018-02
• Study Completion: 2018-02
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-07
• Last Update Posted: 2018-03-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Number of Patients with Reduced Portal Pressure After Intervention	6 Months	the number of Patients with Reduced Portal Pressure After Intervention

Trial Locations

Locations (1)

Sherief Abd-Elsalam; 🇪🇬 Tanta, Egypt