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Fontan Imaging Biomarkers (FIB) Study

NCT ID: NCT03119090

Last Updated: 2021-11-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-09-30

Study Completion Date

2021-07-31

Brief Summary

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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

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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

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Single-ventricle Congenital Heart Disease

Keywords

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biomarkers Fontan operation Single ventricle congenital heart disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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)
Minimum Eligible Age

3 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Evan's Heart Fund

UNKNOWN

Sponsor Role collaborator

Mend a Heart Foundation

UNKNOWN

Sponsor Role collaborator

Matthew Hearts of Hope Foundation

UNKNOWN

Sponsor Role collaborator

Boston Children's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Rahul Rathod

Cardiologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rahul H Rathod, MD

Role: PRINCIPAL_INVESTIGATOR

Boston Children's Hospital

Locations

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Boston Children's Hospital

Boston, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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IRB-P00017430

Identifier Type: -

Identifier Source: org_study_id