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

T

Tanta University

Status and phase

Completed
Phase 4

Conditions

Portal Hypertension

Treatments

Drug: Simvastatin

Study type

Interventional

Funder types

Other

Identifiers

NCT02994485
Nadia Elwan

Details and patient eligibility

About

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.

Full 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.

Enrollment

40 patients

Sex

All

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

40 participants in 2 patient groups

Simvastatin
Active Comparator group
Description:
Simvastatin 20 mg/day for two weeks (increased to 40 mg/day at day 15) for another two weeks
Treatment:
Drug: Simvastatin
no treatment
No Intervention group
Description:
no treatment

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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