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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02994485
Other study ID # Nadia Elwan
Secondary ID
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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