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Clinical Trials/NCT01929174
NCT01929174
Completed
Not Applicable

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

Oregon Health and Science University1 site in 1 country18 target enrollmentAugust 1, 2013

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Congenital Heart Disease
Sponsor
Oregon Health and Science University
Enrollment
18
Locations
1
Primary Endpoint
Myocardial fibrosis measured by the extracellular volume fraction
Status
Completed
Last Updated
7 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 1, 2013
End Date
March 1, 2019
Last Updated
7 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Craig Broberg

Associate Professor, Cardiovascular Medicine

Oregon Health and Science University

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Myocardial fibrosis measured by the extracellular volume fraction

Time Frame: 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.

Study Sites (1)

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