Evaluation Of The Portal Pressure By Doppler Ultrasound In Cirrhotic Patients Before And After Simvastatin
1 other identifier
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Oct 2016
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2016
CompletedFirst Submitted
Initial submission to the registry
December 13, 2016
CompletedFirst Posted
Study publicly available on registry
December 15, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2018
CompletedMarch 8, 2018
March 1, 2018
1.3 years
December 13, 2016
March 7, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Number of Patients with Reduced Portal Pressure After Intervention
the number of Patients with Reduced Portal Pressure After Intervention
6 Months
Study Arms (2)
Simvastatin
ACTIVE COMPARATORSimvastatin 20 mg/day for two weeks (increased to 40 mg/day at day 15) for another two weeks
no treatment
NO INTERVENTIONno treatment
Interventions
Simvastatin 20 mg/day for two weeks (increased to 40 mg/day at day 15) for another two weeks plus the routine treatment
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Tanta Universitylead
Study Sites (1)
Sherief Abd-Elsalam
Tanta, Egypt
Related Publications (1)
Elwan N, Salah R, Hamisa M, Shady E, Hawash N, Abd-Elsalam S. Evaluation of portal pressure by doppler ultrasound in patients with cirrhosis before and after simvastatin administration - a randomized controlled trial. F1000Res. 2018 Mar 1;7:256. doi: 10.12688/f1000research.13915.1. eCollection 2018.
PMID: 29707200DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- 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 Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principle investigator
Study Record Dates
First Submitted
December 13, 2016
First Posted
December 15, 2016
Study Start
October 1, 2016
Primary Completion
February 1, 2018
Study Completion
February 1, 2018
Last Updated
March 8, 2018
Record last verified: 2018-03