FibroScan for Heart Failure

Not yet recruiting at 6 trial locations

Overseen By CAROLE MEILLEROUX, PharmD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Echosens

Disqualifiers: Chronic liver disease, BMI >40, Heart transplantation, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests FibroScan, a non-invasive tool, to determine if it can safely and accurately assess heart failure without requiring risky procedures like cardiac catheterization, which examines the heart's blood vessels. It targets individuals who have been diagnosed with or are suspected of having heart failure and are scheduled for a right-sided cardiac catheterization. This trial may suit those experiencing heart failure symptoms and whose doctor has scheduled an invasive heart test. As an unphased study, it offers an opportunity to contribute to research that could make heart failure assessments safer and less invasive for future patients.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this device is safe for heart failure patients?

Research has shown that FibroScan is a safe tool for assessing liver stiffness. It has been used safely in individuals with heart problems without causing major issues. However, caution is advised for those with devices like pacemakers or defibrillators, as some studies suggest it might not be suitable.

For most people, FibroScan is easy to handle and avoids the risks associated with more invasive methods. Being non-invasive, it doesn't involve surgery, reducing the chance of complications. Always consult a doctor to determine if it's the right option. ^{1 2 3 4 5}

Why are researchers excited about this trial?

FibroScan is unique because it offers a non-invasive way to assess heart failure by measuring liver stiffness, which is linked to heart health. Unlike traditional methods that rely on symptom management and imaging techniques, FibroScan uses ultrasound technology to provide real-time insights into liver condition, potentially reflecting heart function. Researchers are excited about this method because it could lead to earlier detection and more personalized treatment strategies for heart failure patients, improving outcomes and reducing the need for more invasive procedures.

What evidence suggests that FibroScan is effective for heart failure?

Studies have shown that FibroScan, a non-invasive tool, effectively measures liver stiffness. This is important because heart failure often affects liver function. One study found that measuring liver stiffness can help predict heart failure outcomes, with higher stiffness linked to worse results. Another study showed that patients with higher stiffness faced a much higher risk of serious health issues. These findings suggest that FibroScan, which participants in this trial will use, might help assess heart failure risk, offering a safer option compared to invasive procedures. ^{4 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for individuals with various types of heart failure who are seeking a non-invasive method to assess their heart's function. Participants should be eligible for the standard invasive procedures, but looking for safer alternatives.

Inclusion Criteria

Have read, understood, and signed the informed consent form (ICF)

I am 18 years old or older.

I am suspected or have been diagnosed with heart failure and will have a right-sided heart catheterization.

Exclusion Criteria

Fontan-type circulation

Pregnancy, breastfeeding, or intent to become pregnant during the study

Intent to donate/bank or retrieve eggs (ova, oocytes) or donate sperm during the study

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Baseline measurements of liver stiffness and echocardiographic parameters are taken

1 day

1 visit (in-person)

Evaluation

Participants undergo liver stiffness measurement using FibroScan to evaluate elevated CVP

1 day

1 visit (in-person)

Follow-up

Participants are monitored for any adverse events and the correlation of LSM with clinical parameters

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• FibroScan

Trial Overview

The study tests if FibroScan, along with echocardiography and blood tests, can replace right-sided heart catheterization to measure central venous pressure (CVP) in patients with heart failure.

How Is the Trial Designed?

Group I: Full Cohort Experimental Treatment 4 Interventions

This population will be defined by patients fulfilling all inclusion and exclusion criteria.

Who Is Running the Clinical Trial?

Echosens

Lead Sponsor

Trials

18

Recruited

14,600+

Syneos Health

Collaborator

Trials

181

Recruited

69,600+

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9715860/

Use of liver stiffness measurements in acute decompensated ...

Taniguchi et al. evaluated discharge FibroScan LSM to assess for outcomes, separating the patients into tertiles, with cut‐offs at 4.6 and 6.9 ...

2.

journal-of-cardiology.com

journal-of-cardiology.com/article/S0914-5087(18)30234-X/fulltext

Role of liver stiffness in prediction of adverse outcomes ...

HF results in structural and functional dysfunction leading to impaired filling and ejection of heart chambers.

3.

sciencedirect.com

sciencedirect.com/science/article/pii/S1542356525003325

Effectiveness of Six International Guidelines Using Fibrosis ...

Effectiveness of Six International Guidelines Using Fibrosis-4 and FibroScan for Risk Stratification of Metabolic Dysfunction-associated ...

4.

onlinelibrary.wiley.com

onlinelibrary.wiley.com/doi/10.1111/liv.15801

Liver stiffness as a cornerstone in heart disease risk ...

In a similar setup with 53 hospitalized patients with HF and a follow-up of 24 months, an HR of 4.81 (95% CI: 1.69–13.7) was found for the ...

5.

mdpi.com

mdpi.com/1422-0067/24/21/15665

The Liver in Heart Failure: From Biomarkers to Clinical Risk

This article focuses on the mutual relationship between the heart and liver in HF patients. Any cause of right heart failure can cause hepatic congestion, with ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC5350419/

Safety Profile of Liver FibroScan in Patients with Cardiac ...

The FibroScan is currently contraindicated in patients with cardiac pacemakers (PM) or implantable cardioverter-defibrillators (ICD).

7.

journals.lww.com

journals.lww.com/ajg/fulltext/2015/10001/safety_profile_of_liver_fibroscan__in_patients.2136.aspx

Safety Profile of Liver FibroScan ® in Patients With Cardiac ...

TE with FibroScan can be safely used in patients with a PM or ICD. Preliminary results suggest the prevalence of significant liver fibrosis and steatosis is ...

8.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/28349045/

Safety Profile of Liver FibroScan in Patients with Cardiac ...

The FibroScan is currently contraindicated in patients with cardiac pacemakers (PM) or implantable cardioverter-defibrillators (ICD).

9.

clinicaltrials.gov

clinicaltrials.gov/study/NCT00777725

Non-invasive Assessment of Liver Stiffness/Fibrosis by ...

The main objectives are for determining the benefit and usefulness of Fibroscan (Liver scan) in detecting liver stiffness (a condition caused by ...