Diffuse Myocardial Fibrosis in Fontan Patients

NCT01929174 | Completed

• 1 other identifier: OHSUIRB00009372
• Study Type: observational
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Congenital Heart Disease; Single Ventricle; Myocardial Fibrosis

Keywords

Congenital heart disease; Myocardial fibrosis; Diastolic dysfunction

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Controls

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

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.

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with a single ventricle palliated with a Fontan procedure

Sponsors & Collaborators

• Oregon Health and Science University: lead

Study Sites (1)

Oregon Health and Science Univ.

Portland, Oregon, 97239, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples

MeSH Terms

Conditions

Heart Defects, Congenital; Univentricular Heart

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Craig Broberg

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Cardiovascular Medicine

Study Record Dates

• First Submitted: August 22, 2013
• First Posted: August 27, 2013
• Study Start: August 1, 2013
• Primary Completion: May 1, 2016
• Study Completion: March 1, 2019
• Last Updated: April 16, 2019

Record last verified: 2019-04

Locations

US (1)