An observational study in Fontan Procedure, Hypoplastic Left Heart Syndrome and Tricuspid Atresia, sponsored by University of California, San Francisco. Terminated at 1 site in United States. Open to participants aged 10 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-01-21.
Sponsored by University of California, San Francisco · Observational
The investigators are beginning a clinical research study here at UCSF to learn more about how hearts with single ventricles work. The investigators hypothesize that myocardial strain , as measured by cardiac MRI,in patients with single ventricles differs from normal hearts. This abnormality is associated with depressed cardiac power output and impaired exercise capacity. The study will utilize cardiac magnetic resonance imaging, exercise testing, and lung function testing to study how the single ventricle heart works so that in the future the investigators can improve how the investigators care for patients with this type of congenital heart disease.
The research protocol involves: Cardiac magnetic resonance imaging (MRI of the heart), exercise tests, and lung function tests. Some of these tests are routinely used to follow patients with single ventricles. Some of these tests are part of the research protocol. If you agree to participate in this study, these tests will be performed at UCSF. The results of the routine tests will be shared with your doctor.
Participation will require approximately 30 additional minutes to the cardiac MRI procedure to collect the research data. The exercise tests, and lung function tests time commitment will take about two hours.
65 studies on the registry are indexed under Hypoplastic Left Heart Syndrome; 12 are open to participants now.
This study's enrollment of 13 is below the median of 71 across 23 observational studies indexed under Hypoplastic Left Heart Syndrome.
Browse Hypoplastic Left Heart Syndrome studies →University of California, San Francisco is the lead sponsor of 2,164 studies on the registry; 368 are open to participants now.
Of its 267 completed or terminated interventional studies of FDA-regulated products, 199 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Study subjects: Patients with univentricular hearts who have undergone a Fontan procedure will be recruited for participation in the study.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Global and regional myocardial strain (radial, longitudinal and circumferential) as measured by cardiac MRI.
Time frame: 1 day
This study is terminated, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.
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Hypoplastic Left Heart Syndrome →
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