Diffuse Myocardial Fibrosis in Fontan Patients

Congenital Heart Disease Clinical Trial

Official title:

Heart Failure and Fibrosis in Adult Congenital Heart Patients With a Single Ventricle and Prior Fontan Operation.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01929174
• Other study ID #: OHSUIRB00009372
• Status: Completed
• Start date: August 1, 2013
• Est. completion date: March 1, 2019

Study information

• Verified date: April 2019
• Source: Oregon Health and Science University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: March 1, 2019
• Est. primary completion date: May 1, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Congenital Heart Disease
• Fibrosis
• Heart Defects, Congenital
• Heart Diseases
• Myocardial Fibrosis
• Single Ventricle

Locations

Country	Name	City	State
United States	Oregon Health and Science Univ.	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Oregon Health and Science University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Myocardial fibrosis measured by the extracellular volume fraction	All patients will have measurements of pressure and volume before and after IV fluid administration, as well as computation of their extracellular volume fraction.	1 day of single observation