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Diffuse Myocardial Fibrosis in Fontan Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01929174
Recruitment Status : Completed
First Posted : August 27, 2013
Last Update Posted : April 16, 2019
Sponsor:
Information provided by (Responsible Party):
Craig Broberg, 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.

Condition or disease
Congenital Heart Disease Single Ventricle Myocardial Fibrosis

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Study Type : Observational
Actual Enrollment : 18 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Heart Failure and Fibrosis in Adult Congenital Heart Patients With a Single Ventricle and Prior Fontan Operation.
Actual Study Start Date : August 1, 2013
Actual Primary Completion Date : May 1, 2016
Actual Study Completion Date : March 1, 2019

Resource links provided by the National Library of Medicine


Group/Cohort
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.



Primary Outcome Measures :
  1. 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.


Biospecimen Retention:   Samples Without DNA
Blood samples


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with a single ventricle palliated with a Fontan procedure
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01929174


Locations
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United States, Oregon
Oregon Health and Science Univ.
Portland, Oregon, United States, 97239
Sponsors and Collaborators
Oregon Health and Science University
Investigators
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Principal Investigator: Craig Broberg Oregon Health and Science University
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Responsible Party: Craig Broberg, Associate Professor, Cardiovascular Medicine, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT01929174    
Other Study ID Numbers: OHSUIRB00009372
First Posted: August 27, 2013    Key Record Dates
Last Update Posted: April 16, 2019
Last Verified: April 2019
Keywords provided by Craig Broberg, Oregon Health and Science University:
Congenital heart disease
Myocardial fibrosis
Diastolic dysfunction
Additional relevant MeSH terms:
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Heart Diseases
Fibrosis
Pathologic Processes
Cardiovascular Diseases