Single-ventricleFIBNCT03119090
Fontan Imaging Biomarkers (FIB) Study
An observational study of Single-ventricle and Congenital Heart Disease, run by Boston Children's Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 years and older
- Conditions the study is for
- Single-ventricle, Congenital Heart Disease
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2015to Jul 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients after the Fontan operation
Who may be able to join
- All patients with Fontan circulation undergoing clinically indicated CMR at Boston Children's Hospital will be considered for the study
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Boston Children's Hospital
Boston, Massachusetts, 02115
About this study
Official title: Cross-sectional Analysis of Non-invasive Measures of Ventricular Systolic and Diastolic Function and Biomarkers in the Fontan Circulation
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.
Read the detailed description
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)?
- Conditions
- Single-ventricle, Congenital Heart Disease
- Keywords
- biomarkers, Fontan operation, Single ventricle, congenital heart disease
- Medical subject headings
- Univentricular Heart, Heart Defects, Congenital
What is being measured
The primary outcome is the main question the study is designed to answer.
Biomarkers
Correlation of biomarkers and imaging parameters of ventricular mechanics
Measured: Through study completion, an average of 3 years
Secondary outcomes (2)
Diastolic function
Reproducibility of parameters of systolic function
Measured: Through study completion, an average of 3 years
Systolic function
Reproducibility of parameters of systolic function
Measured: Through study completion, an average of 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2017
- Study startSep 2015
- Primary completionJul 2021
- Study completionJul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Single-ventricleStudies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Evan's Heart Fund, Mend a Heart Foundation, Matthew Hearts of Hope Foundation
- Responsible party
- Principal investigator, Rahul Rathod, Boston Children's Hospital
- Investigators
- Rahul H Rathod, MD, Principal investigator, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03119090
- Sponsor's protocol ID
- IRB-P00017430
- Acronym
- FIB
- Status last verified
- Nov 2021
- First submitted
- 10 Apr 2017
- Last updated
- 5 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cross-sectional Analysis of Non-invasive Measures of Ventricular Systolic and Diastolic Function and Biomarkers in the Fontan Circulation
- ClinicalTrials.gov ID
- NCT03119090
- Acronym / sponsor ID
- FIB / IRB-P00017430
- Conditions
- Single-ventricle, Congenital Heart Disease
- Keywords
- biomarkers, Fontan operation, Single ventricle, congenital heart disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Collaborators
- Evan's Heart Fund, Mend a Heart Foundation, Matthew Hearts of Hope Foundation
- Study start
- Sep 2015
- Primary completion
- Jul 2021 (actual)
- Study completion
- Jul 2021 (actual)
- First posted
- 18 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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)?
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 3 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients after the Fontan operation
Key inclusion criteria (1 listed)
- All patients with Fontan circulation undergoing clinically indicated CMR at Boston Children's Hospital will be considered for the study
Key exclusion criteria (2 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Biomarkers
Time frame: Through study completion, an average of 3 years
Correlation of biomarkers and imaging parameters of ventricular mechanics
2 secondary outcomes
Diastolic function
Time frame: Through study completion, an average of 3 years
Systolic function
Time frame: Through study completion, an average of 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rahul H Rathod, MD principal investigator
Boston Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Single-ventricle and Congenital Heart Disease, run by Boston Children's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biomarkers (time frame: Through study completion, an average of 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2021.