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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00777725




Registration number
NCT00777725
Ethics application status
Date submitted
21/10/2008
Date registered
22/10/2008
Date last updated
21/07/2011

Titles & IDs
Public title
Non-invasive Assessment of Liver Stiffness/Fibrosis by Transient Elastography (Fibroscan) in Patients With Left and/or Right Sided Heart Failure
Scientific title
Non-invasive Assessment of Liver Stiffness/Fibrosis by Transient Elastography (Fibroscan) in Patients With Left and/or Right Sided Heart Failure
Secondary ID [1] 0 0
CP-04/08
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Liver Fibrosis 0 0
Heart Failure 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases
Human Genetics and Inherited Disorders 0 0 0 0
Other human genetics and inherited disorders
Inflammatory and Immune System 0 0 0 0
Connective tissue diseases
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Devices - FibroScan

1 - Chronic stable left sided HF patients

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

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

4 - Control subjects with no evidence of heart disease.


Treatment: Devices: FibroScan
Liver scan, similar to an ultrasound.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Utility of FibroScan in detecting liver stiffness/fibrosis in HF patients
Timepoint [1] 0 0
Once only

Eligibility
Key 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)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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 design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/01/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/03/2011
Sample size
Target
Accrual to date
Final
125
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Alfred Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
Monash University
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
The Alfred
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT00777725
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Pornwalee Porapakkham, Dr
Address 0 0
Monash University
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00777725