Adults with Congenital Heart Disease Awaiting Cardiac Transplantation
PI: Arvind Hoskoppal, MD
Research Coordinator: Morgan Hindes, 412-692-6516
The purpose of this research study is to track the progress of patients with adult congenital heart disease (ACHD) who have been referred to the Heart Transplant Program at UPMC. Medical diagnosis and treatment of congenital heart disease has led to a growing population of adults with unique needs in terms of cardiac care. By focusing on an ACHD subset with heart failure who may be candidates for heart transplant, this research will help clinicians to better understand how transplant eligibility and outcomes for this group of patients differs from other candidates for heart transplant.
Eligibility Criteria
The study population comprises patients with congenital heart disease, who were 18 years of age when put on a transplant list, and who were put on a transplant list on or after Jan. 1, 2000.
Males and Females: Ages 18 and older
Requirements
There are no requirements for participants. Clinical data is taken from the medical record for review and analysis.
Visits: None required
Duration: Not applicable
Status: Enrolls from Current Patient Cases
Aortic Coarctation Treatment Comparison Study
PI: Jacqueline Kreutzer, MD, FACC, FSCAI
Research Coordinator: David Groscost, 412-864-8655
The purpose of this study is to prospectively compare the safety and efficacy of the three alternatives for treatment of coarctation of the aorta. The data collected during this study consists of clinical parameters which are routinely collected at time of clinic visit or during the procedure itself. The study will compare surgery, balloon dilation, and use of a stent to address the condition.
Eligibility Criteria
Patients meeting the following inclusion criteria will be approached for study entry: those who weigh 10 kg (about 22 pounds) or more, who are diagnosed with coarctation of the aorta requiring intervention and for whom no other cardiac surgical procedures are planned that would require surgical repair of the aortic arch narrowing at time of surgery.
Boys: All ages
Girls: All ages
Requirements
As an observational study, nothing changes in terms of the care that the patient will receive. No extra tests or extra visits are required beyond whichever procedure is used for treatment. However additional information about the patient’s specific procedure and outcome will be gathered and included in the study database.
Visits: None beyond normal care
Duration: Patient’s progress will be followed for approximately 5 years.
Status: Enrollment Closed
Atrial Switch Procedure Database Study
PI: Arvind Hoskoppal, MD
Research Coordinator: Morgan Hindes, 412-692-6516
This research program builds a multi-center database of patients who have undergone an atrial switch procedure as an infant to surgically correct a congenital heart condition in which the great arteries (aorta and pulmonary artery) are transposed. Although the atrial switch procedure is rarely done today, researchers hope to collect enough patient information to better understand late outcomes and consequences of the atrial switch as this patient group ages through adulthood.
Eligibility Criteria
The study population comprises patients ages 18 and older who had a prior atrial switch procedure.
Males and Females: Ages 18 and older
Requirements
There are no requirements for participants. Clinical data is taken from the medical record for review and analysis.
Visits: None required
Duration: Not applicable
Status: Enrolls from Current Patient Cases
Cardiac Biomarkers Generated in Children and Adolescents when Exercising
PI: Tyler Harris, MD
Research Coordinator: Cullen Wenzler, 412-692-6762
This prospective study evaluates if cardiac biomarkers, such as troponin levels, can rise to the detectable range in healthy children and adolescents after short bursts of exercise. This will provide useful information to pediatric cardiologists and emergency medicine doctors who are often confronted with a mildly positive troponin level – which can be an indicator of cardiac muscle damage – in a patient who recently exercised and is perhaps complaining of chest pain but is otherwise asymptomatic. Studies have shown that strenuous exercise in adults can lead to troponin elevations, but this has not been evaluated in less strenuous exercise in pediatric patients.
Eligibility Criteria
Subject to certain exclusion criteria, researchers are accepting healthy children and adolescents, aged 7 through 17 years, who can participate in the study exercise regimen.
Boys and Girls: Ages 7 through 17
Requirements
Researchers will conduct electrocardiograms and collect and blood samples to monitor cardiac biomarker levels from healthy pediatric patients before and after exercise.
Visits: 1
Duration: 5 hours
Status: Open to Enrollment
COVID-19 in Adults with Congenital Heart Disease
PI: Arvind Hoskoppal, MD
Research Coordinator: Morgan Hindes, 412-692-6516
To better understand the burden and impact of COVID-19 on adult congenital heart disease (ACHD) patients, this research maintains a multi-center database of ACHD patients who have tested positive for SARS-CoV-2 infection and are considered to have contracted COVID-19. Using the REDCap (Research Electronic Data Capture) data management platform, this research is determining the prevalence of COVID-19 among ACHD patients and helping clinicians to identify risk factors for those likely to develop more severe complications. The database also enables the sharing of health care management practices to optimize results for patients
Eligibility Criteria
The study population comprises patients ages 18 and older with congenital heart disease who undergo testing for SARS-CoV-2 at participating centers and are considered to have contracted COVID-19.
Males and Females: Ages 18 and older
Requirements
There are no requirements for participants. Clinical data is taken from the medical record for review and analysis.
Visits: None required
Duration: Not applicable
Status: Enrolls from Current Patient Cases
Kawasaki Disease/COVID-19 Research Registry
PI: Tyler Harris, MD
Research Coordinator: Cullen Wenzler, 412-692-6762
Through this multi-center study, researchers are collecting data for analysis about pediatric patients with Kawasaki disease (KD) who have pediatric multisystem inflammatory syndrome (PMIS aka MIS-C) and/or confirmed or suspected COVID-19 infection. KD is a rare childhood illness that affects the blood vessels and can harm the coronary arteries, which carry blood to the heart muscle. Through this study, researchers hope to learn more about cardiac complications, including those associated with KD, in pediatric patients with COVID-19.
Eligibility Criteria
This study will include: 1) patients with confirmed or suspected COVID-19 infection for whom there has been a request for echocardiography or pediatric cardiology consultation; 2) patients with a confirmed or suspected diagnosis of KD, or KD shock syndrome; 3) patients with confirmed or suspected PMIS assumed to be associated with COVID-19.
Males and Females: All ages
Requirements
There are no requirements for participants. Clinical data is extracted from the medical record for review and analysis.
Visits: None required
Duration: Not applicable
Status: Open to Enrollment
Neurocognitive Impact of Surgical Re-intervention for Congenital Heart Disease
PI: Bryan Goldstein, MD
Research Coordinator: Cullen Wenzler, 412-692-6762
Through this multi-center study, researchers are investigating the impact on neurocognitive function of a type of heart surgery on people with congenital heart disease who required open heart surgery as an infant.
Eligibility Criteria
Subject to certain exclusion criteria, people with congenital heart disease that required an open-heart operation before the age of 1 and who are now scheduled to undergo a right ventricular outflow tract re-intervention are eligible for this study.
Males and Females: Ages 13 to 30
Requirements
Participants will meet with a member of the research staff upon enrollment and answer a series of questionnaires related to health, quality of life, and brain function. Following surgery, the research team will review the patient’s medical record. At 3 months after surgery, participants will be asked to complete two surveys by mail. The surveys will be repeated by mail at the 1-year interval. The research team will also screen participants for signs of depression in a follow-up phone call.
Visits: 1, which can be done at the time of a regularly scheduled visit
Duration: 1 year
Status: Enrolls from Current Patient Cases
Patent Ductus Arteriosus Closure with MVP™ Plug: A Retrospective Review
PI: Sara Trucco, MD
Research Coordinator: Cullen Wenzler, 412-692-6762
This multi-center retrospective review studies outcomes of infants who weighed less than 2 kilograms (about 4.4 pounds) when their patent ductus arteriosus (PDA) condition was treated with a Medtronic MVP™ micro vascular plug. PDA is a condition that occurs when a hole in the aorta that allows blood to bypass circulation to the lungs does not close normally during fetal development. The study will review safety, efficacy, complications, and outcomes 6 months after the catheterization procedure.
Eligibility Criteria
Patients who underwent PDA closure with the MVP Microvascular Plug between Jan. 1, 2012, and Oct. 30, 2020, will be included in the study.
Males and Females: Newborns
Requirements
There are no requirements for participants. Clinical data is extracted from the medical record for review and analysis.
Visits: None required
Duration: Not applicable
Status: Enrolls from Current Patient Cases
Pediatric and Congenital Heart Disease with Heart Failure – Treatment with Advanced Cardiac Therapies: The ACTION Project
PI: Matthew Zinn, DO
Research Coordinator: Maggie Abraham, CCRC, 412-692-6601
The ACTION Learning Network consists of clinicians, researchers, parents, and patients from across a wide variety of medical institutions. The goal is to improve critical outcomes for children with heart failure by uniting providers and families, sharing data and outcomes transparently, improving education and standardizing best practices. The current focus is on improving outcomes for pediatric ventricular assist device (VAD) patients. The goal of this network learning approach is to expedite improvements across the collaborative system. Other heart failure initiatives will follow.
Eligibility Criteria
Subject to certain exclusion criteria, this study is enrolling patients implanted with either a durable or temporary ventricular assist device (VAD) or a total artificial heart, and patients admitted to the hospital with heart failure or being followed on an outpatient basis with heart failure, regardless of cause.
Males and Females: All Ages
Requirements
There are no requirements for participants at this time. Clinical data is extracted from the medical record for review and analysis.
Visits: Not applicable
Duration: Not applicable
Status: Enrolls from Current Patient Cases
Pediatric Heart Transplant Database
PI: Brian Feingold, MD
Research Coordinators: Maggie Abraham, CCRC, 412-692-6061
The Pediatric Heart Transplant Study (PHTS) database is a large, ongoing multi-center study about heart transplant patients to review outcomes and help learn more about heart transplants. Information collected for this study will be sent to a central data collection center at the University of Alabama at Birmingham. More than 50 pediatric centers are participating in the PHTS.
Eligibility Criteria
All pediatric heart transplant candidates or recipients cared for at Children’s Hospital of Pittsburgh of UPMC will be approached for enrollment in this study. Patients over 18 years of age at the time of listing for transplant will not be enrolled.
Boys: Newborn to 17 years
Girls: Newborn to17 years
Requirements
With the consent of parents/guardians, medical information routinely collected for a child’s clinical care will be submitted to the PHTS database from the time the child is listed, with additional data added yearly prior to transplant and every 3 months after transplant. No extra testing or visits are required. The data is submitted in anonymous fashion.
Visits: None outside of standard clinical care
Duration: Until patient is no longer followed at Children’s Hospital of Pittsburgh
Status: Enrolls Only from Current Patient Cases
Pediatric Heart Transplant Immunosuppressive Therapy Comparing Two Regimens: The TEAMMATE Study – Phase III
PI: Brian Feingold, MD
Research Coordinators: Maggie Abraham, CCRC, 412-692-6061
The purpose of this multi-center study is to learn more about which anti-rejection medications best protect infants, children, adolescents, and young adults after they have had a heart transplant. Researchers hope to learn which medications are best at preventing rejection, and also which medications are best at preventing long-term problems after heart transplant, including kidney disease, infection, coronary artery disease, and post-transplant lymphoproliferative disease. Researchers will be comparing effectiveness of the current standard of care for pediatric heart transplant immunosuppression, a combination of the drugs tacrolimus (TAC) and mycophenalate mofetil (MMF), to another regimen using low-dose tacrolimus (LDTAC) and everolimus (EVL).
Study Level: Phase III
Eligibility Criteria
The study is enrolling people who were younger than 21 at the time of their heart transplant, providing that they show no sign of rejection at their 6-month post-surgery evaluation.
Males and Females: Patients who had a heart transplant at an age less than 21
Requirements
Following screening participants will be randomly segmented into groups that will either take TAC plus MMF or LDTAC plus EVL. Participants will be seen by the study team for testing and evaluations every 3 months for 4 visits and again every 6 months thereafter for the final 3 visits.
Visits: 8 including screening
Duration: 30 months
Status: Enrolls from Current Patient Cases
Pregnancy and Congenital Heart Disease
PI: Anita Saraf, MD
Research Coordinator: Morgan Hindes, 412-692-6516
This study collects medical record information about adult congenital heart disease (ACHD) patients who are pregnant with an aim of creating a health care blueprint for pregnant women with ACHD. It will include pregnant women from disparate backgrounds and will stratify their cardiovascular disease burden with a risk algorithm
Eligibility Criteria
The study population comprises female patients ages 18 and older with congenital heart disease who are pregnant.
Females: Ages 18 and older
Requirements
There are no requirements for participants. Clinical data is taken from the medical record for review and analysis.
Visits: None required
Duration: Not applicable
Status: Enrolls from Current Patient Cases
Pulmonary Arteriovenous Malformation Causes Study
PI: Sara Trucco, MD
Research Coordinator: Morgan Hindes, 412-692-6516
The purpose of this research is to better understand the development of pulmonary arteriovenous malformations (AVMs) in children following vascular surgery addressing problems caused by some congenital heart conditions. AVMs can lower blood oxygen levels, creating new risks for the patient. Researchers theorize that certain proteins made in the liver and heart that may help prevent development of AVMs may not be reaching the lungs following surgery. The research will compare levels of two proteins, bone morphogenetic proteins 9 and 10 (BMP9 and BMP10), in blood taken from different parts of the heart.
Eligibility Criteria
The study is enrolling people ages 2 months through 17 years, with or without structural heart disease, who are scheduled for a clinically indicated cardiac catheterization.
Males and Females: Ages 2 months through 17 years
Requirements
During the patient’s heart catheterization blood will be drawn from 5 locations, as per routine care, and will be analyzed to determine the amount of BMP9 and BMP10 present to determine if there are higher levels entering the lungs than exiting.
Visits: None beyond those required for treating the given condition
Duration: Not applicable
Status: Enrollment Pending
Pulmonary Atresia Treatment in Neonates via Pulmonary Valve Perforation: A Retrospective Review
PI: Sara Trucco, MD
Research Coordinator: Cullen Wenzler, 412-692-6762
This retrospective review examines outcomes of using radio frequency (RF) or chronic total occlusion (CTO) devices to open the pulmonary valves of patients who had pulmonary atresia with an intact ventricular septum (PA/IVS) between 2007 and 2019. Pulmonary atresia is a rare condition in which the pulmonary valve that controls blood flow to the lungs, is blocked. RF perforation and CTO device perforation of the valve are techniques done via minimally invasive heart catheterization.
Eligibility Criteria
Patients with a diagnosis of PA/IVS who were referred to the Cardiac Catheterization Laboratory at UPMC Children’s Hospital of Pittsburgh for treatment from 2007 through 2019 for attempted perforation of their atretic pulmonary valve will be included in the review.
Males and Females: Neonates
Requirements
There are no requirements for participants. Clinical data is extracted from the medical record for review and analysis.
Visits: None required
Duration: Not applicable
Status: Enrolls from Current Patient Cases
Pulmonary Blood Flow Treatment with Stent versus Shunt
PI: Sara Trucco, MD
Research Coordinator: Cullen Wenzler, 412-692-6762
This is a prospective chart review of infants treated with either of two interventional strategies to correct pulmonary blood flow problem caused by a congenital heart defect. Researchers will compare outcomes of the standard surgical strategy using a surgical shunt with a newer intervention using ductal stenting to determine the optimal therapeutic approach.
Eligibility Criteria
The study will evaluate cases where interventions were done for babies less than 60 days old who had a congenital heart condition with ductal dependent blood flow, such as patent ductus arteriosus, causing low oxygen saturation.
Males and Females: Less than 60 days old at time of surgery
Requirements
There are no requirements for participants. Clinical data is extracted from the medical record for review and analysis.
Visits: None required
Duration: Not applicable
Status: Enrolls from Current Patient Cases
Pulmonary Valve Stenosis Identification Before Birth
PI: Jennifer Johnson, DO
Research Coordinator: David Groscost, MSHA, RN, 412-864-8655
The purpose of this multi-center retrospective chart review study is to determine how fetal pulmonary valve stenosis, as determined by echocardiogram, compares to newborn pulmonary valve stenosis, with a goal of improving post-delivery management and care. Pulmonary valve stenosis, a condition where the heart valve that helps blood flow to the lungs is impaired, accounts for about 85 to 12% of congenital heart disease in children.
Eligibility Criteria
The study will evaluate cases where mothers, ages 18 and older, delivered babies who had a fetal diagnosis of pulmonary valve stenosis, a post-delivery transthoracic echocardiogram, and pulmonary balloon valvuloplasty procedure.
Males and Females: Newborns
Requirements
There are no requirements for participants. Clinical data is taken from the medical record for review and analysis.
Visits: None required
Duration: Not applicable
Status: Enrolls from Current Patient Cases
Pulmonary Vein Stenosis Study
PI: Sara Trucco, MD
Research Coordinator: Cullen Wenzler, 412-692-6762
This is a prospective chart review of patients diagnosed with pulmonary vein stenosis, a rare blockage in the vessels that return blood from the lungs to the heart. The objective is to better understand disease mechanisms and outcomes for these patients so that clinicians can plan better intervention strategies and improve clinical results.
Eligibility Criteria
Patients ranging from premature infants to teens up to 18 years of age with a clinical diagnosis of pulmonary vein stenosis will be included in this study.
Males and Females: Ages newborn to 18 years
Requirements
There are no requirements for participants. Clinical data is extracted from the medical record for review and analysis.
Visits: None required
Duration: Not applicable
Status: Enrolls from Current Patient Cases
Renal Fitness in Young Adults with Congenital Heart Disease
PI: Dana Fuhrman, DO, MS
Research Coordinator: Morgan Hindes, 412-692-6516
The purpose of this research study is to evaluate ways to find kidney disease early in adult congenital heart disease (ACHD) patients. A healthy kidney should be able to increase its filtration fraction in response to a stimulator such as a high dose of protein. This ability is called “kidney reserve.” A lack of renal fitness may indicate a poor ability of the kidney to respond to external stressors. Researchers hope to determine if ACHD patients have kidney reserve and, if so, the levels of urine proteins can be used to predict future kidney injury.
Eligibility Criteria
The study is enrolling males and females, ages 18 to 40, with a history of congenital heart disease and plans for surgery in the near future.
Males and Females: Ages 18 to 40
Requirements
For Part 1 of the study, participants will visit the Pediatric Clinical and Translational Research Center of UPMC Children’s Hospital of Pittsburgh in advance of their surgery for an examination and to provide blood and urine samples. Part 2 occurs when participants are admitted to the hospital for surgery, at which time researchers will monitor blood creatinine levels and urine production until the patient leaves.
Visits: 1 to 3
Duration: Dependent on surgery scheduling and ends with Part 2
Status: Open to Enrollment
Supraventricular Tachycardia Management – A Treatment Comparison Study
PI: Gaurav Arora, MD
Research Coordinator: David Groscost, MSHA, RN, 412-864-8655
This study seeks to compare the known efficacy and adverse effects of calcium channel blocker therapy as compared to beta blocker therapy when used for the chronic treatment of non-preexcited supraventricular tachycardia (SVT) in patients without hemodynamically significant heart disease.
Eligibility Criteria
The study will evaluate the medical records of patients who were age 1 to 21 at the time of their diagnosis of SVT.
Males and Females: Ages 1 through age 21
Requirements
There are no requirements for participants. Clinical data is taken from the medical record for review and analysis.
Visits: None required
Duration: Not applicable
Status: Enrolls from Current Patient Cases
Transplant EBV Disease Study
PI: Diana M. Metes, MD
Research Coordinator: Maggie Abraham, CCRC, 412-692-6061
The goal of this Epstein-Barr virus (EBV) study is to better understand the nature of EBV infection after organ transplantation and determine why different amounts of this virus stay in the bodies of children who have received transplants. It will also explore why some of these children tolerate the virus well with no symptoms, while others experience serious disease due to EBV. Study researchers hope to better understand infections caused by EBV and develop better methods of treating illness caused by EBV.
Eligibility Criteria
Children and young adults under the age of 21 who have undergone heart, lung or heart/lung transplant at the UPMC Children’s Hospital of Pittsburgh are eligible to participate in this study.
Boys: Newborn through 20 years
Girls: Newborn through 20 years
Requirements
The study team will obtain small blood draws during the course of the patient’s normal examinations at regular intervals and for up to 5 years following the participant’s transplant.
Visits: No visits beyond regular patient examinations
Duration: Up to 5 years
Status: Closed to Enrollment
Wolff-Parkinson-White Syndrome in Children Database
PI: Gaurav Arora, MD
Research Coordinator: Maggie Abraham, 412-692-6061
The purpose of this 10-year observational multi-center database study is to provide information about the outcomes of children with symptomatic and asymptomatic Wolff-Parkinson-White syndrome and to improve risk assessment using clinical and invasive electrophysiologic study data. Wolff-Parkinson-White syndrome is a rare condition in which an extra electrical pathway in the heart can cause rapid heartbeat.
Eligibility Criteria
The study will evaluate cases where of patients with a diagnosis of Wolff-Parkinson-White syndrome who are being followed at UPMC Children’s Hospital of Pittsburgh.
Males and Females: Birth through age 21
Requirements
There are no requirements for participants. Clinical data is taken from the medical record for review and analysis.
Visits: None required
Duration: Not applicable
Status: Enrolls from Current Patient Cases
