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NCT03119090 Clinical Trial

Fontan Imaging Biomarkers (FIB) Study

Congenital Heart Disease Clinical Trial

— FIB  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03119090
Other study ID # IRB-P00017430
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 2015
Est. completion date July 2021

Study information
Verified date November 2021
Source Boston Children's Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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 information / eligibility
Status Completed
Enrollment 200
Est. completion date July 2021
Est. primary completion date July 2021
Accepts healthy volunteers No
Gender All
Age group 3 Years and older
Eligibility 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)

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States Boston Children's Hospital Boston Massachusetts

Sponsors (4)
Lead Sponsor Collaborator
Boston Children's Hospital Evan's Heart Fund, Matthew Hearts of Hope Foundation, Mend a Heart Foundation

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Biomarkers Correlation of biomarkers and imaging parameters of ventricular mechanics Through study completion, an average of 3 years
Secondary Diastolic function Reproducibility of parameters of systolic function Through study completion, an average of 3 years
Secondary Systolic function Reproducibility of parameters of systolic function Through study completion, an average of 3 years
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