Studies Enrolling Subjects

ClinicalTrials.gov provides searchable information on Clinical Trials and Human Research Studies. Click here for the Trial List for a search on “Congenital Heart Disease.”

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Research Study Notice:

What is the rationale of the study?

This study is being completed by a Ph.D. Candidate in Clinical Pediatric Neuropsychology, Ashlee Loughan.  Ashlee is the mother of a sweet 4 year old boy, who was born with Transposition of the Great Arteries.  This experience has directed her fascination in the population of children with CHD and she hopes to one day specialize in CHD Pediatric Neuropsychology. The purpose of this study is to determine the executive function profile of children with congenital heart defects (CHD) and compare those who have cyanotic CHD and acyanotic CHD against their peers with no CHD. If executive dysfunction is found among CHD populations, this may suggest the need for early intervention for the CHD children to assist in future academic and life success.

Who is eligible?

Parents of children with CHD who are between the ages 5-18 are eligible.

Specific Congenital Heart Defects that are eligible:

d-Transposition of the Great Arteries

Tetralogy of Fallot

Hypoplastic Right Heart

Hypoplastic Left Heart

Double Outlet Right Ventricle Truncus Arteriosus

Single Ventricle

Total Anomalous Pulmonary Venous Connection

Critical Coarctation

Critical Pulmonic Stenosis

Pulmonic Stenosis

Atrioventricular Septal Defect

Aortic Stenosis

Ventricular Septal Defect

Patent Ductus Arteriosus

What factors exclude eligibility?

The only factors which exclude eligibility is if the child is outside the investigated age range, they not have a CHD, or they have a CHD which is not listed above.

What are the major risks and benefits of participation?

No risks are expected during the completion of this study. The benefits include assisting to understand the executive functioning of children with CHD. If the participant decided to provide contact information (address), a one page summer of the overall study findings will be mailed to them upon study completion.

How do people interested in joining the study get involved?

The survey is available online and can be accessed via this link: https://www.surveymonkey.com/s/CHDResearch

This brief anonymous (if you choose) questionnaire will take only 15 minutes to complete.

What is the purpose of the study?
The study seeks to measure the amount of myocardial fibrosis (a stiffening of the heart muscle) using magnetic resonance imaging (MRI), an imaging test where a patient lies inside a scanner for about an hour, performed together with blood tests and an echocardiogram. Fibrosis may likely be a reason why heart function decreases over time in some patients with congenital heart disease.

Who is eligible?
Adult patients (age >18) with tetralogy of Fallot, transposition of the great arteries (with a Mustard or Senning operation), or cyanotic heart disease.

What factors exclude eligibility?
Patients who have significant kidney dysfunction (as determined by recent blood tests), pacemaker or defibrillator, or who cannot undergo MRI scanning for any other reason. Patients should expect to be able to return to Portland in one year.

What are the major risks and benefits of participation?
Patients will have an MRI, echocardiogram, blood tests, and be asked to walk in a hallway for 6 minutes on the first day of the study. Blood will be used to measure levels of specific proteins that are likely involved in fibrosis. All tests including MRI and echo will be repeated one year later. Study procedures are paid for by the research study, but there is no payment made to study participants. Risks and discomforts are kept to a minimum. Patients will have an “IV” placed in a vein in their vein. The MRI scan will involve lying flat for a time inside the scanner and may not be tolerated by some with claustrophobia or who are short of breath when lying down. The contrast agent used is not known to be harmful in individuals with normal kidney function. Patient information is kept confidential, unless shared with the patients health care providers at their request.

Some study recipients will be eligible to be in an additional side study, and be given a medication called spironolactone (or placebo), which can cause high potassium levels. Blood tests are scheduled regularly for those patients receiving the medication. There are no other major risks. Patients will not be expected to benefit personally from participating, although the blood tests and imaging tests may potentially demonstrate findings that could alter their treatment. All patients may benefit from insights gained from the study.

How do people interested in joining the study get involved?
Contact Dr. Broberg at brobergc@ohsu.edu, or by calling 503-494-8750

For more information, visit the clinicaltrials.gov page on this study by clicking here.

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Research Study Notice:

Condition being studied: An infant is diagnosed with PHACE syndrome when he or she has a large hemangioma in combination with one or more other abnormalities. The hemangioma is usually on the face or neck. “PHACE” refers to a group of abnormal medical findings. When these occur together, the diagnosis of PHACE syndrome is made.

“PHACE” stands for these symptoms:
Posterior fossa- These are brain malformations. They are usually present at birth. They do not form after the baby is born.
Hemangioma- The hemangioma is a strawberry birthmark and usually covers a large area on the skin of the head or neck. The word "segmental" is sometimes used to describe the hemangiomas.
Arterial lesions- The abnormalities of the blood vessels in the neck or head.
Cardiac defects/aortic coarctation- These are abnormalities of the heart or the blood vessels attached to the heart.
Eye abnormalities.

Criteria used to determine eligibility: Subjects with a facial hemangioma plus one additional feature may enroll in this study.

Benefits: You will not personally benefit from participating in this study. But by serving as a subject, you may contribute new information which may benefit patients in the future.

Burdens: If the results of these studies of your genetic makeup were to be released through a breach of confidentiality, this could affect your ability to get insurance or to get or keep a job. Blood drawing will cause some pain. Blood drawing carries a small risk of bleeding, bruising or infection at the puncture site. Some of the questions asked for this study may seem very personal. You may find some questions embarrassing. There will be no payment for enrolling in this study.

Time commitment: About 15 minutes for the blood draw and 15 minutes to complete the surveys. The blood draw can be done a local laboratory.

Location research being conducted:
Oregon Health & Science University
Clinical Investigator:
Dawn Siegel, MD
Assistant Professor Dermatology and Pediatrics
Oregon Health & Science University
Mail Code: CH16D
3303 SW Bond Ave.
Portland, OR 97239
Office: (503) 346-0029
siegeld@ohsu.edu

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An estimated 1,000,000 adult Americans have congenital heart defects (CHD), yet less than 10% are receiving the recommended care. How do we find those missing adults? It would help to know how they became lost to care and what could bring them back. Click here to see the results from the recent Survey Monkey survey that was posted on ACHA's website at the end of May 2007.

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The Adult Congenital Heart Association's (ACHA) purpose, when listing current research studies seeking volunteers, is solely to inform adults with congenital heart disease of the opportunities which exist. ACHA does not support, or otherwise endorse, any particular study. Adults with congenital heart disease interested in participating in a study should contact the specific research center directly. The responsibility for benefits and risks of the study are assumed totally by the researchers and properly informed test volunteers and not by the Adult Congenital Heart Association.