Diffuse Myocardial Fibrosis in Fontan Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

18 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-08-01

Study Completion Date

2019-03-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Congenital Heart Disease Single Ventricle Myocardial Fibrosis

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Controls

Patients undergoing catheterization for other reasons who have a normal biventricular heart.

No interventions assigned to this group

Single ventricle Fontan

Patients with a single functional ventricle (excluding hypoplastic left heart syndrome) palliated with a "Fontan" type operation involving passive blood flow to the lungs.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No