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

NCT ID: NCT00777725

Last Updated: 2011-07-21

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 125 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2009-01-31
• Study Completion Date: 2011-03-31

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.

Conditions

Liver Fibrosis; Heart Failure

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

1

Chronic stable left sided HF patients

FibroScan

Intervention Type: DEVICE

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

FibroScan

Intervention Type: DEVICE

Liver scan, similar to an ultrasound.

3

Acute decompensated left sided heart failure patients who have volume overload and have been admitted for diuresis

FibroScan

Intervention Type: DEVICE

Liver scan, similar to an ultrasound.

4

Control subjects with no evidence of heart disease.

FibroScan

Intervention Type: DEVICE

Liver scan, similar to an ultrasound.

Interventions

FibroScan

Liver scan, similar to an ultrasound.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

The Alfred

OTHER

Sponsor Role: collaborator

Monash University

OTHER

Sponsor Role: lead

Responsible Party

Monash University

Principal Investigators

Pornwalee Porapakkham, Dr

Role: PRINCIPAL_INVESTIGATOR

Monash University

Locations

Alfred Hospital

Melbourne, Victoria, Australia

Countries

Australia

Other Identifiers

CP-04/08

Identifier Type: -

Identifier Source: org_study_id