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

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

Status

Terminated

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00188045

Enrollment

Registered

2005-09-16

Start date

1995-04-30

Completion date

2003-12-31

Last updated

2017-11-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alcoholic Cirrhosis

Keywords

Portal hypertension, alcoholic cirrhosis, Hepatic venous pressure gradient, hemodynamic, spironolactone, propranolol

Brief 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.

Interventions

DRUGPropranolol - Spironolactone

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
assessment of hepatic veinous pressure gradient changes after chronic treatment by spironolactone or propranolol alone or in association.	—

Secondary

Measure	Time frame
Efficacy of spironolactone/propranolol association	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026