Status:
UNKNOWN
Multimodality Biomarkers for Noninvasive Assessment of the Fontan Patient
Lead Sponsor:
Maria Bano
Conditions:
Single-ventricle
Myocardial Fibrosis
Eligibility:
All Genders
10-40 years
Phase:
NA
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 betw...
Detailed Description
This is a single center prospective longitudinal 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...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
January 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2025
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT03263312
Start Date
January 1 2018
End Date
June 1 2025
Last Update
September 5 2021
Active Locations (1)
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1
Children'sMCD
Irving, Texas, United States, 75063