Hemodynamic Effects of Chronic Administration of Spironolactone and/or Propranolol in Alcoholic Cirrhotic Patients

Alcoholic Cirrhosis Clinical Trial

Official title:

Hemodynamic Effects of Chronic Administration of Spironolactone, Propranolol and Their Association in Alcoholic Cirrhotic Patients

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00188045
• Other study ID #: PHRC 01-13
• Status: Terminated
• Phase: Phase 4
• First received: September 12, 2005
• Last updated: October 30, 2017
• Start date: April 1995
• Est. completion date: December 2003

Study information

• Verified date: December 2001
• Source: University Hospital, Angers
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study was assesment of splanchnic and systemic hemodynamic effects of chronic administration (2 month) of spironolactone or propranolol, alone or in association in alcoholic cirrhotic patients. The patients were randomized in 4 groups (aldactone 150 mg/day, propranolol 160 mg/day, aldactone 150 mg/day + propranolol 160 mg/day, placebo). Systemic and splanchnic hemodynamic effect were evaluated by hepatic venous pressure gradient measurements before and after 2 month of treatment.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 54
• Est. completion date: December 2003
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Indication of transjugular hepatic biopsy

• alcoholic cirrhosis

• presence of oesophageal varices = stade 2

Exclusion Criteria:

• renal insufficiency

• natremia = 135 mmol/l

• vasoactive treatment in the last month before inclusion

• hepatocellular carcinoma

• positive HIV and HCV patients

• paracentesis in the last week before inclusion

• digestive bleeding in one last week

• oesophageal varices stade 3 or 2 with red signs

Related Conditions & MeSH terms

• Alcoholic Cirrhosis
• Fibrosis
• Liver Cirrhosis, Alcoholic

Intervention

Drug:
• Propranolol - Spironolactone

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Angers

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	assessment of hepatic veinous pressure gradient changes after chronic treatment by spironolactone or propranolol alone or in association.
Secondary	Efficacy of spironolactone/propranolol association