Diffuse Myocardial Fibrosis in Fontan Patients

Completed

• Conditions: Congenital Heart Disease; Single Ventricle; Myocardial Fibrosis

• Registration Number: NCT01929174
• Lead Sponsor: Oregon Health and Science University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-08-01
• Study First Submitted: 2013-08-22
• Study First Submitted QC: 2013-08-26
• Study First Posted: 2013-08-27
• Primary Completion: 2016-05-01
• Study Completion: 2019-03-01
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-13
• Last Update Posted: 2019-04-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Myocardial fibrosis measured by the extracellular volume fraction	1 day of single observation	All patients will have measurements of pressure and volume before and after IV fluid administration, as well as computation of their extracellular volume fraction.

Trial Locations

Locations (1)

Oregon Health and Science Univ.; 🇺🇸 Portland, Oregon, United States