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

This study has been completed.
Sponsor:
Collaborator:
The Alfred
Information provided by:
Monash University
ClinicalTrials.gov Identifier:
NCT00777725
First received: October 21, 2008
Last updated: July 20, 2011
Last verified: July 2011
  Purpose

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.


Condition Intervention
Liver Fibrosis
Heart Failure
Device: FibroScan

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Non-invasive Assessment of Liver Stiffness/Fibrosis by Transient Elastography (Fibroscan) in Patients With Left and/or Right Sided Heart Failure

Resource links provided by NLM:


Further study details as provided by Monash University:

Primary Outcome Measures:
  • Utility of FibroScan in detecting liver stiffness/fibrosis in HF patients [ Time Frame: Once only ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Blood samples for fibrotic biomarkers.


Enrollment: 125
Study Start Date: January 2009
Study Completion Date: March 2011
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1
Chronic stable left sided HF patients
Device: FibroScan
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
Device: FibroScan
Liver scan, similar to an ultrasound.
3
Acute decompensated left sided heart failure patients who have volume overload and have been admitted for diuresis
Device: FibroScan
Liver scan, similar to an ultrasound.
4
Control subjects with no evidence of heart disease.
Device: FibroScan
Liver scan, similar to an ultrasound.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Acute and chronic heart failure patients

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00777725

Locations
Australia, Victoria
Alfred Hospital
Melbourne, Victoria, Australia, 3004
Sponsors and Collaborators
Monash University
The Alfred
Investigators
Principal Investigator: Pornwalee Porapakkham, Dr Monash University
  More Information

No publications provided

Responsible Party: Dr Pornwalee Porapakkham, Monash University
ClinicalTrials.gov Identifier: NCT00777725     History of Changes
Other Study ID Numbers: CP-04/08
Study First Received: October 21, 2008
Last Updated: July 20, 2011
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

Additional relevant MeSH terms:
Dextrocardia
Fibrosis
Heart Failure
Liver Cirrhosis
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities
Situs Inversus
Pathologic Processes
Liver Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on August 28, 2014