Multimodality Biomarkers for Noninvasive Assessment of the Fontan Patient
Status unconfirmed · Not applicable
Conditions studied: Single-ventricle, Myocardial Fibrosis
In brief
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.
Key facts
- Study ID
- NCT03263312
- Run by
- Maria Bano
- People needed
- 50
- Starts
- 2018-01-01
- Expected to finish
- 2025-06-01
- Last updated by the study team
- 2021-09-05
Who can join
Age: 10 and older, up to 40. Sex: any. Healthy volunteers: accepted.
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
Where it is running
- Children'sMCD — Irving, Texas, United States
Full record on ClinicalTrials.gov
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