Diffuse Myocardial Fibrosis in Fontan Patients
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Peripheral Vascular Disease, Cardiology, Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - 90 |
| Updated: | 9/21/2018 |
| Start Date: | August 1, 2013 |
| End Date: | March 1, 2019 |
Heart Failure and Fibrosis in Adult Congenital Heart Patients With a Single Ventricle and Prior Fontan Operation.
The purpose of this protocol is to measure the relaxation of the heart in subjects with
single ventricles who have undergone the surgical Fontan procedure. We will do this by
measuring relaxation with MRI, echocardiography, and cardiac catheterization and compare to
blood levels that measure heart scarring. We will also measure relaxation before and after
boluses of intravenous (IV) fluids to see if the relaxation changes when there is more fluid
in the heart. Measurements of heart relaxation will be obtained from the MRI, echocardiogram,
and cardiac catheterization for each patient and compared to blood markers of heart scarring.
We aim to compare all of these measurements to see if we can accurately identify heart
scarring and, if present, how much it correlates with impaired heart relaxation.
single ventricles who have undergone the surgical Fontan procedure. We will do this by
measuring relaxation with MRI, echocardiography, and cardiac catheterization and compare to
blood levels that measure heart scarring. We will also measure relaxation before and after
boluses of intravenous (IV) fluids to see if the relaxation changes when there is more fluid
in the heart. Measurements of heart relaxation will be obtained from the MRI, echocardiogram,
and cardiac catheterization for each patient and compared to blood markers of heart scarring.
We aim to compare all of these measurements to see if we can accurately identify heart
scarring and, if present, how much it correlates with impaired heart relaxation.
Inclusion criteria: adult patients (age ≥18) with a previous Fontan procedure (including
all variants) referred for catheterization. This includes individuals with tricuspid
atresia, double inlet left ventricle, unbalanced atrioventricular septal defect, and
pulmonary atresia with intact septum. Control subjects will be selected from individuals
referred to the lab for evaluation/closure of a patent foramen ovale (PFO). All subjects
must be willing to participate in all portions of the study and provide written informed
consent.
Exclusion criteria: contraindications to MRI such as ferromagnetic objects in the chest,
claustrophobia, or contraindication to gadolinium contrast (estimated creatinine clearance
< 30 ml/min/1.73m2). Fontan patients with a morphologic right ventricle (namely hypoplastic
left heart after a Norwood palliation) will be excluded, because of the disproportionate
risk of systolic dysfunction in the morphologic right ventricle.33 Control patients with
hypertension, diabetes, coronary disease, or reduced systolic function will be excluded.
We found this trial at
1
site
3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
Portland, Oregon 97239
503 494-8311
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
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