Fontan Imaging Biomarkers (FIB) Study
- Conditions
- Congenital Heart DiseaseSingle-ventricle
- Registration Number
- NCT03119090
- Lead Sponsor
- Boston Children's Hospital
- 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)?
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 200
- All patients with Fontan circulation undergoing clinically indicated CMR at Boston Children's Hospital will be considered for the study
- 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)
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Biomarkers Through study completion, an average of 3 years Correlation of biomarkers and imaging parameters of ventricular mechanics
- Secondary Outcome Measures
Name Time Method Systolic function Through study completion, an average of 3 years Reproducibility of parameters of systolic function
Diastolic function Through study completion, an average of 3 years Reproducibility of parameters of systolic function
Trial Locations
- Locations (1)
Boston Children's Hospital
🇺🇸Boston, Massachusetts, United States