Status:
COMPLETED
Non-invasive Assessment of Liver Stiffness/Fibrosis by Transient Elastography (Fibroscan) in Patients With Left and/or Right Sided Heart Failure
Lead Sponsor:
Monash University
Collaborating Sponsors:
The Alfred
Conditions:
Liver Fibrosis
Heart Failure
Eligibility:
All Genders
18+ years
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 t...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 1 2011
Estimated Enrollment :
125 Patients enrolled
Trial Details
Trial ID
NCT00777725
Start Date
January 1 2009
End Date
March 1 2011
Last Update
July 21 2011
Active Locations (1)
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1
Alfred Hospital
Melbourne, Victoria, Australia, 3004