Multimodality Biomarkers for Noninvasive Assessment of the Fontan Patient
1 other identifier
interventional
50
1 country
1
Brief Summary
This is a single center prospective longitudinal exercise training study and will enroll approximately 50 Fontan patients and 20 controls of a similar age, gender, BMI and physical activity level between the ages of 10-40 years. Participants will undergo an MRI of the Fontan circulation. This will include imaging of the heart, lung and liver. This will include specific imaging for tissue characterization and assessment of myocardial fibrosis, liver fibrosis and disproportionate pulmonary blood flow. The investigators will then draw blood (approximately 10 ml) for assessment of serum biomarkers and circulating microRNAs of interest. The participants will undergo exercise testing and will then start a 3-6 month long cardiac rehabilitation program. After the 3-6 month study period the participants will return back for a follow up and repeat all the testing completed at enrollement.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2018
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 24, 2017
CompletedFirst Posted
Study publicly available on registry
August 28, 2017
CompletedStudy Start
First participant enrolled
January 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2025
CompletedSeptember 5, 2021
September 1, 2021
7.4 years
August 24, 2017
September 2, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Peak VO2
Improvement in Peak VO2 with 6 months of exercise training
6 months
Study Arms (1)
Fontan Patients
EXPERIMENTALAll Fontan patients included in this study will be part of an exercise intervention 2-6 times/week for 3-6 months.
Interventions
Eligibility Criteria
You may qualify if:
- Presence of a congenital heart defect that leads to single ventricle physiology
- Previously performed TCPA surgery
- Current age 10 years to 40 years
- Informed consent
You may not qualify if:
- History of exercise intolerance (peak VO2\<12ml/kg/min)
- Unstable arrhythmia at the time of screening
- Listed or being evaluated for heart transplantation
- Pregnancy or breast feeding
- Patient with pacemaker, AV block other than 1st degree block, sick sinus syndrome or other arrhythmia that may influence ability to perform exercise test or magnetic resonance imaging
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Maria Banolead
Study Sites (1)
Children'sMCD
Irving, Texas, 75063, United States
Related Publications (1)
Bano M, Hussain T, Samels MR, Butts RJ, Kirk R, Levine BD. Cardiovascular remodelling in response to exercise training in patients after the Fontan procedure: a pilot study. Cardiol Young. 2024 Mar;34(3):604-613. doi: 10.1017/S1047951123003153. Epub 2023 Sep 4.
PMID: 37664999DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
August 24, 2017
First Posted
August 28, 2017
Study Start
January 1, 2018
Primary Completion
June 1, 2025
Study Completion
June 1, 2025
Last Updated
September 5, 2021
Record last verified: 2021-09
Data Sharing
- IPD Sharing
- Will not share