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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
Sponsor:
Collaborators:
Evan's Heart Fund
Mend a Heart Foundation
Matthew Hearts of Hope Foundation
Information provided by (Responsible Party):
Rahul Rathod, 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.

Condition or disease
Single-ventricle Congenital Heart Disease

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)?

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
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





Primary Outcome Measures :
  1. Biomarkers [ Time Frame: Through study completion, an average of 3 years ]
    Correlation of biomarkers and imaging parameters of ventricular mechanics


Secondary Outcome Measures :
  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


Biospecimen Retention:   Samples Without DNA
Blood and urine samples are biobanked for current and future study.


Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients after the Fontan operation
Criteria

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)

Information from the National Library of Medicine

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


Contacts
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Contact: Rahul H Rathod, MD 617-355-4890 rahul.rathod@childrens.harvard.edu
Contact: Sunil J Ghelani, MD 617-355-4890 Sunil.Ghelani@cardio.chboston.org

Locations
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United States, Massachusetts
Boston Children's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Rahul H Rathod, MD    617-355-4890    rahul.rathod@childrens.harvard.edu   
Sponsors and Collaborators
Boston Children's Hospital
Evan's Heart Fund
Mend a Heart Foundation
Matthew Hearts of Hope Foundation
Investigators
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Principal Investigator: Rahul H Rathod, MD Boston Children's Hospital
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Responsible Party: Rahul Rathod, Cardiologist, Boston Children's Hospital
ClinicalTrials.gov Identifier: NCT03119090    
Other Study ID Numbers: IRB-P00017430
First Posted: April 18, 2017    Key Record Dates
Last Update Posted: July 7, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Rahul Rathod, Boston Children's Hospital:
biomarkers
Fontan operation
Single ventricle
congenital heart disease
Additional relevant MeSH terms:
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Heart Diseases
Cardiovascular Diseases