Back to resultsEvaluation Of The Portal Pressure By Doppler Ultrasound In Cirrhotic Patients Before And After Simvastatin
Primary Purpose
Portal Hypertension
Status
Completed
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Simvastatin
Sponsored by
About this trial
This is an interventional treatment trial for Portal Hypertension
Eligibility Criteria
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
Sites / Locations
- Sherief Abd-Elsalam
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Simvastatin
no treatment
Arm Description
Simvastatin 20 mg/day for two weeks (increased to 40 mg/day at day 15) for another two weeks
no treatment
Outcomes
Primary Outcome Measures
Number of Patients with Reduced Portal Pressure After Intervention
the number of Patients with Reduced Portal Pressure After Intervention
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02994485
Brief Title
Evaluation Of The Portal Pressure By Doppler Ultrasound In Cirrhotic Patients Before And After Simvastatin
Official Title
Evaluation Of The Portal Pressure By Doppler Ultrasound In Cirrhotic Patients Before And After Simvastatin
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
October 2016 (undefined)
Primary Completion Date
February 2018 (Actual)
Study Completion Date
February 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tanta University
4. Oversight
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Portal Hypertension
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Simvastatin
Arm Type
Active Comparator
Arm Description
Simvastatin 20 mg/day for two weeks (increased to 40 mg/day at day 15) for another two weeks
Arm Title
no treatment
Arm Type
No Intervention
Arm Description
no treatment
Intervention Type
Drug
Intervention Name(s)
Simvastatin
Other Intervention Name(s)
Corvast
Intervention Description
Simvastatin 20 mg/day for two weeks (increased to 40 mg/day at day 15) for another two weeks plus the routine treatment
Primary Outcome Measure Information:
Title
Number of Patients with Reduced Portal Pressure After Intervention
Description
the number of Patients with Reduced Portal Pressure After Intervention
Time Frame
6 Months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
NADIA ELWAN, PROFESSOR
Organizational Affiliation
Tanta university hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
RAAFAT SALAH, PROFESSOR
Organizational Affiliation
Tanta university hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
MANAL HAMISA, Ass Prof
Organizational Affiliation
Tanta university hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
EBTESAM A SHADY, BACHELOR
Organizational Affiliation
Tanta University hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Sherief Abd-Elsalam
City
Tanta
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
29707200
Citation
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.
Results Reference
derived
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Evaluation Of The Portal Pressure By Doppler Ultrasound In Cirrhotic Patients Before And After Simvastatin
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