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

Sponsor

Tanta University (Other)

Overall Status

Completed

CT.gov ID

NCT02994485

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

2.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Portal Hypertension	Drug: Simvastatin	Phase 4

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 Design

Study Type:

Interventional

Actual Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Oct 1, 2016

Actual Primary Completion Date :

Feb 1, 2018

Actual Study Completion Date :

Feb 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Simvastatin Simvastatin 20 mg/day for two weeks (increased to 40 mg/day at day 15) for another two weeks	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 Other Names: Corvast
No Intervention: no treatment no treatment

Arm

Intervention/Treatment

Active Comparator: Simvastatin

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

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

Other Names:

Corvast

No Intervention: no treatment

no treatment

Outcome Measures

Primary Outcome Measures

Number of Patients with Reduced Portal Pressure After Intervention [6 Months]
the number of Patients with Reduced Portal Pressure After Intervention

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sherief Abd-Elsalam	Tanta		Egypt

Sponsors and Collaborators

Tanta University

Investigators

Principal Investigator: NADIA ELWAN, PROFESSOR, Tanta university hospital
Study Chair: RAAFAT SALAH, PROFESSOR, Tanta university hospital
Study Chair: MANAL HAMISA, Ass Prof, Tanta university hospital
Study Chair: EBTESAM A SHADY, BACHELOR, Tanta University hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Sherief Abd-Elsalam, Principle investigator, Tanta University

ClinicalTrials.gov Identifier:

NCT02994485

Other Study ID Numbers:

Nadia Elwan

First Posted:

Dec 15, 2016

Last Update Posted:

Mar 8, 2018

Last Verified:

Mar 1, 2018

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Additional relevant MeSH terms:

Hypertension, Portal

Simvastatin

Study Results

No Results Posted as of Mar 8, 2018