Fontan Imaging Biomarkers (FIB) Study (FIB)
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|ClinicalTrials.gov Identifier: NCT03119090|
Recruitment Status : Recruiting
First Posted : April 18, 2017
Last Update Posted : July 7, 2020
|Condition or disease|
|Single-ventricle Congenital Heart Disease|
This study has the following research questions:
- What is the reproducibility of ventricular systolic function measurements (including ventricular strain) in Fontan patients using echocardiography (Echo) and cardiac magnetic resonance imaging (CMR)?
- What is the reproducibility of ventricular diastolic function measurements (including tissue Doppler and strain rate) in Fontan patients using Echo and CMR?
- Is there a correlation between ventricular function measurements and circulating biomarkers (including galectin-3 levels, NT-proBNP, ST2, and MELD-XI score)?
|Study Type :||Observational|
|Estimated Enrollment :||200 participants|
|Official Title:||Cross-sectional Analysis of Non-invasive Measures of Ventricular Systolic and Diastolic Function and Biomarkers in the Fontan Circulation|
|Study Start Date :||September 2015|
|Estimated Primary Completion Date :||July 2021|
|Estimated Study Completion Date :||July 2022|
- Biomarkers [ Time Frame: Through study completion, an average of 3 years ]Correlation of biomarkers and imaging parameters of ventricular mechanics
- Diastolic function [ Time Frame: Through study completion, an average of 3 years ]Reproducibility of parameters of systolic function
- Systolic function [ Time Frame: Through study completion, an average of 3 years ]Reproducibility of parameters of systolic function
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03119090
|Contact: Rahul H Rathod, MDfirstname.lastname@example.org|
|Contact: Sunil J Ghelani, MD||617-355-4890||Sunil.Ghelani@cardio.chboston.org|
|United States, Massachusetts|
|Boston Children's Hospital||Recruiting|
|Boston, Massachusetts, United States, 02115|
|Contact: Rahul H Rathod, MD 617-355-4890 email@example.com|
|Principal Investigator:||Rahul H Rathod, MD||Boston Children's Hospital|