Liver FibrosisNCT00777725
Non-invasive Assessment of Liver Stiffness/Fibrosis by Transient Elastography (Fibroscan) in Patients With Left and/or Right Sided Heart Failure
An observational study of Liver Fibrosis and Heart Failure, run by Monash University at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Liver Fibrosis, Heart Failure
- What is being tested?
- FibroScan
- Type of treatment
- Medical device
- How many people
- 125 participants
- Where
- 1 siteAustralia
- Study dates
- Jan 2009to Mar 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Acute and chronic heart failure patients
Who may be able to join
- 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:
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- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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
- Being tested
- FibroScan
- Medical subject headings
- Liver Cirrhosis, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FibroScanDevice
Liver scan, similar to an ultrasound.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Chronic stable left sided HF patients Receives: Device: FibroScan | |
| 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 Receives: Device: FibroScan | |
| 3 | Acute decompensated left sided heart failure patients who have volume overload and have been admitted for diuresis Receives: Device: FibroScan | |
| 4 | Control subjects with no evidence of heart disease. Receives: Device: FibroScan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Utility of FibroScan in detecting liver stiffness/fibrosis in HF patients
Measured: Once only
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2008 (estimated)
- Study startJan 2009
- Primary completionOct 2010
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver FibrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- Monash University
- Sponsor type
- University, hospital or other
- Collaborators
- The Alfred
- Investigators
- Pornwalee Porapakkham, Dr, Principal investigator, Monash University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00777725
- Sponsor's protocol ID
- CP-04/08
- Status last verified
- Jul 2011
- First submitted
- 21 Oct 2008
- Last updated
- 21 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-invasive Assessment of Liver Stiffness/Fibrosis by Transient Elastography (Fibroscan) in Patients With Left and/or Right Sided Heart Failure
- ClinicalTrials.gov ID
- NCT00777725
- Acronym / sponsor ID
- CP-04/08
- Conditions
- Liver Fibrosis, Heart Failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- Monash UniversityUniversity, hospital or other
- Collaborators
- The Alfred
- Study start
- Jan 2009
- Primary completion
- Oct 2010 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 22 Oct 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Device: FibroScanChronic stable left sided HF patients |
| 2 | – | Device: FibroScanPredominant right sided HF patients secondary to valvular heart disease, pulmonary artery hypertension (PAH), chronic obstructive pulmonary disease (COPD), or thrombotic disease and etc |
| 3 | – | Device: FibroScanAcute decompensated left sided heart failure patients who have volume overload and have been admitted for diuresis |
| 4 | – | Device: FibroScanControl subjects with no evidence of heart disease. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Acute and chronic heart failure patients
Key inclusion criteria (15 listed)
- 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)
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FibroScanLiver scan, similar to an ultrasound. | Device | 1, 2, 3, 4 |
Primary outcome
Utility of FibroScan in detecting liver stiffness/fibrosis in HF patients
Time frame: Once only
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pornwalee Porapakkham, Dr principal investigator
Monash University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Fibrosis and Heart Failure, run by Monash University at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Utility of FibroScan in detecting liver stiffness/fibrosis in HF patients (time frame: Once only). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2011.