NCT03119090

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2015

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

April 10, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 18, 2017

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2021

Completed
Last Updated

November 5, 2021

Status Verified

November 1, 2021

Enrollment Period

5.8 years

First QC Date

April 10, 2017

Last Update Submit

November 4, 2021

Conditions

Single-ventricleCongenital Heart Disease

Keywords

biomarkersFontan operationSingle ventriclecongenital heart disease

Outcome Measures

Primary Outcomes (1)

  • Biomarkers

    Correlation of biomarkers and imaging parameters of ventricular mechanics

    Through study completion, an average of 3 years

Secondary Outcomes (2)

  • Diastolic function

    Through study completion, an average of 3 years

  • Systolic function

    Through study completion, an average of 3 years

Eligibility Criteria

Age3 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients after the Fontan operation

You may qualify if:

  • All patients with Fontan circulation undergoing clinically indicated CMR at Boston Children's Hospital will be considered for the study

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood and urine samples are biobanked for current and future study.

MeSH Terms

Conditions

Univentricular HeartHeart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Rahul H Rathod, MD

    Boston Children's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Cardiologist

Study Record Dates

First Submitted

April 10, 2017

First Posted

April 18, 2017

Study Start

September 1, 2015

Primary Completion

July 1, 2021

Study Completion

July 1, 2021

Last Updated

November 5, 2021

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)