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

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.

Study Overview

• Status: Completed
• Conditions: Heart Failure; Liver Fibrosis
• Intervention / Treatment: Device: FibroScan

• Study Type: Observational
• Enrollment (Actual): 125

Contacts and Locations

Study Locations

• Australia
  • Victoria
    • Melbourne, Victoria, Australia, 3004
      • Alfred Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Acute and chronic heart failure patients

Description

Inclusion Criteria:

1. Males and females.
2. Age > 18 years.
3. Confirmed written informed consent.
4. Patients/subjects are divided into 4 groups (total 100 patients/subjects).

Group 1: Chronic stable left sided HF patients who attend the Alfred Hospital. (30 patients)

• Chronic stable left sided HF cohort defined as:
• Echocardiographic evidence of systolic or diastolic heart failure (see appendix A for criteria)
• CHF patients in Class I or class II NYHA symptoms who used to have a minimum of one acute decompensated episode in the past and now their clinical is stable.

Group 2: Predominant right sided HF patients secondary to valvular heart disease, pulmonary artery hypertension (PAH), chronic obstructive pulmonary disease (COPD), or thrombotic disease and etc. (30 patients)

Group 3: Acute decompensated left sided HF patients who have volume overload and have been admitted for diuresis. (10 patients)

• Acute decompensated left sided HF cohort defined as:
• Objective evidence of left sided heart failure (of any cause/etiology) demonstrated by typical symptoms/signs combined with an imaging modality (see appendix A for criteria)
• Requirement for intravenous diuretic whilst either an inpatient or in an emergency room setting with intravenous diuretics, vasodilators or inotropes
• No ejection fraction cut-off will be required, i.e. both systolic and diastolic heart failure patients can be enrolled

Group 4: Control group: age and gender matched with no history of heart disease, no history of heavy alcoholic consumption, no known history of familial hyperlipidemia, no history of viral hepatitis and body mass index (BMI) less than 27. (30 subjects)

Exclusion Criteria:

1. Patients with a history of a psychological illness or condition such as to interfere with the patient's ability to understand the requirements of the study
2. History of alcoholism or current alcohol intake > 4 standard drinks/day
3. Known chronic liver disease of etiology other than heart failure

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
1; Chronic stable left sided HF patients	Device: FibroScan; Liver scan, similar to an ultrasound.
2; Predominant right sided HF patients secondary to valvular heart disease, pulmonary artery hypertension (PAH), chronic obstructive pulmonary disease (COPD), or thrombotic disease and etc	Device: FibroScan; Liver scan, similar to an ultrasound.
3; Acute decompensated left sided heart failure patients who have volume overload and have been admitted for diuresis	Device: FibroScan; Liver scan, similar to an ultrasound.
4; Control subjects with no evidence of heart disease.	Device: FibroScan; Liver scan, similar to an ultrasound.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Utility of FibroScan in detecting liver stiffness/fibrosis in HF patients	Once only

Collaborators and Investigators

• Sponsor: Monash University
• Collaborators: The Alfred
• Investigators: Principal Investigator: Pornwalee Porapakkham, Dr, Monash University

Study record dates

Study Major Dates

• Study Start: January 1, 2009
• Primary Completion (Actual): October 1, 2010
• Study Completion (Actual): March 1, 2011

Study Registration Dates

• First Submitted: October 21, 2008
• First Submitted That Met QC Criteria: October 21, 2008
• First Posted (Estimate): October 22, 2008

Study Record Updates

• Last Update Posted (Estimate): July 21, 2011
• Last Update Submitted That Met QC Criteria: July 20, 2011
• Last Verified: July 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Congenital Abnormalities; Liver Diseases; Heart Defects, Congenital; Cardiovascular Abnormalities; Situs Inversus; Fibrosis; Heart Failure; Liver Cirrhosis; Dextrocardia
• Other Study ID Numbers: CP-04/08