Fontan Imaging Biomarkers (FIB) Study

Cross-sectional Analysis of Non-invasive Measures of Ventricular Systolic and Diastolic Function and Biomarkers in the Fontan Circulation

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03119090

Acronym

FIB

Enrollment

200

Registered

2017-04-18

Start date

2015-09-30

Completion date

2021-07-31

Last updated

2021-11-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Congenital Heart Disease, Single-ventricle

Keywords

biomarkers, Fontan operation, Single ventricle, congenital heart disease

Brief summary

The goal of the Fontan Imaging Biomarkers (FIB) study is to identify the associations of blood and urine biomarkers to imaging parameters of ventricular mechanics.

Detailed description

This study has the following research questions: 1. What is the reproducibility of ventricular systolic function measurements (including ventricular strain) in Fontan patients using echocardiography (Echo) and cardiac magnetic resonance imaging (CMR)? 2. What is the reproducibility of ventricular diastolic function measurements (including tissue Doppler and strain rate) in Fontan patients using Echo and CMR? 3. Is there a correlation between ventricular function measurements and circulating biomarkers (including galectin-3 levels, NT-proBNP, ST2, and MELD-XI score)?

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

3 Years to No maximum

Healthy volunteers

Inclusion criteria

* All patients with Fontan circulation undergoing clinically indicated CMR at Boston Children's Hospital will be considered for the study

Exclusion criteria

* Inadequate imaging quality to perform proposed analysis * Patients \<15 kg will be excluded to simplify compliance with BCH minimal risk research blood draw volume guidelines (minimal risk is defined as \< 5% total blood volume)

Design outcomes

Primary

Measure	Time frame	Description
Biomarkers	Through study completion, an average of 3 years	Correlation of biomarkers and imaging parameters of ventricular mechanics

Secondary

Measure	Time frame	Description
Diastolic function	Through study completion, an average of 3 years	Reproducibility of parameters of systolic function
Systolic function	Through study completion, an average of 3 years	Reproducibility of parameters of systolic function

Countries

United States

Outcome results