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

Portal Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02994485
• Other study ID #: Nadia Elwan
• Status: Completed
• Phase: Phase 4
• First received: December 13, 2016
• Last updated: March 7, 2018
• Start date: October 2016
• Est. completion date: February 2018

Study information

• Verified date: March 2018
• Source: Tanta University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: February 2018
• Est. primary completion date: February 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Hypertension, Portal
• Portal Hypertension

Intervention

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

Locations

Country	Name	City	State
Egypt	Sherief Abd-Elsalam	Tanta

Sponsors (1)

Lead Sponsor	Collaborator
Tanta University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Patients with Reduced Portal Pressure After Intervention	the number of Patients with Reduced Portal Pressure After Intervention	6 Months