NCT03119090

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
• Phase: —
• Study type: Observational
• Enrollment: 200 (actual)
• Sponsor: Boston Children's Hospital · Academic / Other
• Sex: All
• Age: 3 Years
• Healthy volunteers: Not accepted

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)?

Conditions

• Single-ventricle
• Congenital Heart Disease

Timeline

• Start date: 2015-09-01
• Primary completion: 2021-07-01
• Completion: 2021-07-01
• First posted: 2017-04-18
• Last updated: 2021-11-05

Locations

1 site across 1 country: United States