Utilization of FibroScan in Fontan Associated Liver Disease prior to and after heart transplant or placement of single ventricle ventricular assist device

Enrolling By Invitation
17 years or below
All
Phase N/A
20 participants needed

Brief description of study

What is the purpose of this study?

In this study, we propose to assess: 1) the role of FibroScan in patients with FALD prior to and after heart transplant or placement of single ventricle ventricular assist device (SVAD); 2) the association between liver stiffness measurement (LSM) from FibroScan and cardiac events, all-cause mortality, and worse post-operative outcome after heart transplant and SVAD; and 3) long term FALD after heart transplant and SVAD.

THIS STUDY IS ENROLLING BY INVITATION ONLY - Potential participants with single ventricle who have previously undergone Fontan procedure and are on the heart transplant list or will undergo an SVAD implant will be identified by pediatric cardiology. Study team will confirm eligibility and meet with family in private clinic room to discuss participation. Alternatively, study team may call the potential participants prior to their appointment to discuss study with them.

Detailed description of study

What will happen during the study?

In this study, we propose to assess: 1) the role of FibroScan in patients with FALD prior to and after heart transplant; 2) the association between liver stiffness measurement (LSM) from FibroScan and cardiac events, all-cause mortality, and worse post-operative outcome after heart transplant; and 3) long term FALD after heart transplant.

OBJECTIVES 1) Characterize the change in LSM after heart transplant. 2) Determine the association of LSM and cardiac events in patients with FALD after heart transplant. 3) Characterize progression of FALD after heart transplant. 4) Determine if SVAD implant as a final or intermediate step impacts FALD.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Fontan-Associated Liver Disease, FALD
  • Age: 17 years or below
  • Gender: All

Inclusion Criteria:

  1. Patients with single ventricle who have previously undergone Fontan procedure and are on the heart transplant list or will undergo an SVAD implant.

Exclusion Criteria: . 

  1. Study clinical information absent from electronic medical record.
    Patients with other causes of chronic liver disease or liver transplant.

Updated on 25 Nov 2024. Study ID: PGI-IIR-FALDHEARTTX, PGI-IIR-FIBROSCAN, 24584
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