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Completed

NCT Number: NCT03119090

Fontan Imaging Biomarkers (FIB) Study

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.

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Key information

Conditions

Single-ventricle Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital Heart Disease Congenital, Hereditary, and Neonatal Diseases and Abnormalities Heart Defects, Congenital Heart Diseases Univentricular Heart

Age range

3 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

About this study

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)?

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. Biomarkers

    Time frame: Through study completion, an average of 3 years

    Correlation of biomarkers and imaging parameters of ventricular mechanics

Secondary outcomes

  1. Diastolic function

    Time frame: Through study completion, an average of 3 years

    Reproducibility of parameters of systolic function

  2. Systolic function

    Time frame: Through study completion, an average of 3 years

    Reproducibility of parameters of systolic function

Sponsors and collaborators

Lead sponsor

Boston Children's Hospital

Other

Collaborators

  • Evan's Heart Fund
  • Matthew Hearts of Hope Foundation
  • Mend a Heart Foundation

Registry information

Official study title

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

Acronym: FIB

Important dates

Study start
2015
Primary completion
2021
Study completion
2021
First posted
Apr 18, 2017
Registry last updated
Nov 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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