Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Fontan Imaging Biomarkers (FIB) Study (FIB)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03119090
Recruitment Status : Recruiting
First Posted : April 18, 2017
Last Update Posted : July 28, 2021
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

Tracking Information
First Submitted Date April 10, 2017
First Posted Date April 18, 2017
Last Update Posted Date July 28, 2021
Study Start Date September 2015
Estimated Primary Completion Date July 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 13, 2017)
Biomarkers [ Time Frame: Through study completion, an average of 3 years ]
Correlation of biomarkers and imaging parameters of ventricular mechanics
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: April 13, 2017)
  • 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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Fontan Imaging Biomarkers (FIB) Study
Official Title Cross-sectional Analysis of Non-invasive Measures of Ventricular Systolic and Diastolic Function and Biomarkers in the Fontan Circulation
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.
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)?
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
Blood and urine samples are biobanked for current and future study.
Sampling Method Non-Probability Sample
Study Population Patients after the Fontan operation
Condition
  • Single-ventricle
  • Congenital Heart Disease
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: April 13, 2017)
200
Original Estimated Enrollment Same as current
Estimated Study Completion Date July 2022
Estimated Primary Completion Date July 2021   (Final data collection date for primary outcome measure)
Eligibility 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)
Sex/Gender
Sexes Eligible for Study: All
Ages 3 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
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
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03119090
Other Study ID Numbers IRB-P00017430
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Rahul Rathod, Boston Children's Hospital
Study Sponsor Boston Children's Hospital
Collaborators
  • Evan's Heart Fund
  • Mend a Heart Foundation
  • Matthew Hearts of Hope Foundation
Investigators
Principal Investigator: Rahul H Rathod, MD Boston Children's Hospital
PRS Account Boston Children's Hospital
Verification Date July 2021