Clinical Trial: Non-invasive Assessment of Liver Stiffness/Fibrosis by Transient Elastography (Fibroscan) in Patients With Left and/or Right Sided Heart Failure

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Non-invasive Assessment of Liver Stiffness/Fibrosis by Transient Elastography (Fibroscan) in Patients With Left and/or Right Sided Heart Failure

Brief Summary:

This study will involve 70 patients who attend the Alfred Hospital with acute or chronic heart failure as well as 30 age and gender matched control subjects. All participants will have their history taking and a physical examination to detect symptoms and signs of heart failure.

The main objectives are for determining the benefit and usefulness of Fibroscan (Liver scan) in detecting liver stiffness (a condition caused by excess fluid build up in the liver which has a negative impact on the livers ability to function properly) in heart failure patients and for characterizing the incidence and severity of liver stiffness in this group of patients.

After informed consent, a blood sample will be taken from all patients to assess their full blood examination, glucose, lipid profiles, renal function and so on.

Then 24-48 hours after enrollment, the liver doctors will do the liver scan (Fibroscan) by transient elastography. All the data are recorded and further analysis will be assessed.

In a small group of acute patients the blood tests and liver scan will be repeated just prior to their discharge.

Optional Sub-study: For participants who consent to the optional sub-study another 20 ml of blood for serum liver fibrotic markers will be collected.

Detailed Summary:
Sponsor: Monash University

Current Primary Outcome: Utility of FibroScan in detecting liver stiffness/fibrosis in HF patients [ Time Frame: Once only ]

Original Primary Outcome: Utility of FibroScan in detecting liver stiffness/fibrosis in HF patients [ Time Frame: On one occassion for each participant except acute patients who will also be assessed at hospital discharge. ]

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Monash University

Dates:
Date Received: October 21, 2008
Date Started: January 2009
Date Completion:
Last Updated: July 20, 2011
Last Verified: July 2011