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.

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Key information

Conditions

Liver Fibrosis Cardiovascular Diseases Digestive System Diseases Fibrosis Heart Diseases Heart Failure Liver Cirrhosis Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Alfred Hospital

Melbourne, Victoria, 3004, Australia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Males and females.
Age > 18 years.
Confirmed written informed consent.
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

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
History of alcoholism or current alcohol intake > 4 standard drinks/day
Known chronic liver disease of etiology other than heart failure

Treatment and study plan

FibroScan

Device

Liver scan, similar to an ultrasound.

Primary outcomes

Utility of FibroScan in detecting liver stiffness/fibrosis in HF patients

Time frame: Once only

Sponsors and collaborators

Lead sponsor

Monash University

Other

Collaborators

The Alfred

Registry information

Important dates

Study start: 2009
Primary completion: 2010
Study completion: 2011
First posted: Oct 22, 2008
Registry last updated: Jul 21, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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