Congenital heart disease

This study tests a special stent designed to keep a small heart vessel open in babies under 6 months old who have a congenital heart defect. The goal is to improve blood flow to the lungs and delay or avoid open-heart surgery. About 35 infants will receive the stent and be monito…

This international study is evaluating a minimally invasive procedure to close a type of heart defect called a perimembranous ventricular septal defect (PmVSD) — a hole between the heart's lower chambers. The procedure uses a small device inserted through a catheter to plug the h…

Some people are born with only one working lower heart chamber, a condition often managed with a Fontan operation. Over time, that single ventricle can weaken, leading to Fontan circulatory failure, where the heart struggles to pump enough oxygen-rich blood. This trial tests whet…

This trial asks whether clamping the umbilical cord at 120 seconds after birth is better than clamping at 30 seconds for babies born with congenital heart disease. About 500 infants with a prenatal heart defect diagnosis will be randomly assigned to one of the two timings. Resear…

This study tests a special heart valve that can be adjusted to fit children as they grow. It involves 36 kids aged 1.5 to 16 years with congenital heart disease who need a new pulmonary valve. The valve is placed during surgery and can later be expanded without another operation.

This study tests a compact heart-lung machine called Cardiohelp in 50 children with severe heart failure. The device supports the heart for up to 30 days while kids recover or await a transplant. The trial also compares two blood thinners to see which causes fewer bleeding or clo…

This trial tests a new model of care called PEN-Plus, which brings specialized treatment for severe chronic diseases like diabetes, heart conditions, and sickle cell disease to first-level hospitals in Zambia. The goal is to train local health workers and set up clinics to manage…

This study is testing a device called the Occlutech mVSD Occluder to close a type of hole in the heart (muscular ventricular septal defect) without open surgery. The device is inserted through a blood vessel in the leg and guided to the heart. Researchers will follow 50 patients …

This study tests whether dapagliflozin, a drug already approved for diabetes and heart failure, can improve exercise ability and heart function in people who have had the Fontan procedure. About 30 participants aged 12 and older will take the drug daily for 3 months. The goal is …

This study is testing a new heart valve (SAPIEN 3) in 108 people who have a dysfunctional right ventricle outflow tract (RVOT) due to a congenital heart defect or a previous valve replacement. The goal is to see if the valve is safe and effective at improving blood flow and reduc…

This study looks at 200 infants under 1 year old who had heart surgery for congenital heart disease. After their breathing tube is removed, they will get one of two standard breathing supports: High Flow Nasal Cannula or Non-Invasive Positive Pressure Ventilation. The goal is to …

This trial tests a 12-week neurocardiac rehabilitation program for children, adolescents, and young adults with moderate to complex congenital heart disease. The program combines home-based physical exercise, telehealth psychoeducation for parents and children, and computerized c…

This study tests a program to help young adults with congenital heart disease transition from pediatric to adult care. The program includes a nurse check-in, a diagnosis summary, an education day, and a handover video call. Researchers will track whether this reduces hospital vis…

This study tests whether a home monitoring program can reduce complications and deaths in infants who had heart surgery. Parents will measure their child's heart rate, oxygen levels, and weight at home and send the data daily via a secure app. The program includes alerts for worr…

This study tests a lifestyle program designed to help teens and young adults (ages 15-25) with congenital heart disease become more physically active. Participants will receive a Fitbit, a personalized exercise plan, and education on healthy living. The goal is to see if the prog…

This study tests whether a high-energy diet helps infants with congenital heart disease grow and develop their brains better after heart surgery. Researchers will compare high-energy versus standard nutrition in 160 babies aged 0-6 months. The goal is to see if the special diet i…

This study tests whether a 12-week home-based cardiac rehabilitation program can improve heart function and quality of life in children aged 8 to 18 with complex congenital heart disease. Participants will be randomly assigned to either the remote rehab program or standard care. …

This study tests whether a home-based digital exercise program can increase physical activity and fitness in children aged 10-17 with Fontan circulation, a heart condition. Participants will wear an activity tracker for 12 months and complete fitness tests. The goal is to see if …

This early-stage trial tests whether heart cells grown from a patient's own stem cells are safe to inject into people with severe congenital heart disease. About 50 participants will receive the cells or be in a control group. The main goal is to check for serious side effects wi…

This study compares performing heart surgery on newborns with complex congenital heart disease either before or after 7 days of age. Researchers will track which timing leads to fewer deaths and better recovery. The trial involves 738 babies across multiple hospitals in China.

This study tests whether a cardiometabolic clinic can help obese adults with heart disease lose weight and improve health. Sixty participants will receive care from the clinic and be followed for 12 months. Researchers will measure weight loss, body mass index, and fat distributi…

This study tests whether the drug Entresto (sacubitril-valsartan) can improve heart structure and function in adults with congenital heart disease. 45 participants will take either Entresto or a placebo for 52 weeks. Researchers will measure heart changes, blood markers, and qual…

This study tests whether injecting a child's own heart stem cells (JRM-001) after reconstructive surgery can improve heart function in children with single ventricle heart defects. About 40 children scheduled for Glenn or Fontan surgery will receive either the stem cells or a pla…

This study tests a new type of heart valve made from a patient's own tissue to treat a leaky pulmonary valve. Seven adults will receive the valve to see if it is safe and works well in the short term. The valve is designed to grow with the patient, potentially reducing the need f…

This trial is developing an AI-powered device that listens to children's heart, breath, and bowel sounds to identify signs of common diseases like congenital heart disease, bronchopneumonia, and abdominal issues. It will involve 30,000 children aged 0-18, some with these conditio…

This study tests whether a machine learning algorithm can better detect critical congenital heart disease (CCHD) in newborns by combining standard oxygen saturation measurements with perfusion index data. Researchers will enroll up to 320 infants, including those with suspected o…

This study is developing a computer program that can analyze heart sounds recorded with a digital stethoscope to tell if a newborn's heart is healthy or not. Researchers will record heart sounds from 1,000 babies under 30 days old and use those recordings to train and test the pr…

This study is testing a new non-invasive vest that uses 128 electrodes to map the heart's electrical activity in people with congenital heart disease. The goal is to see if this method can accurately identify areas causing abnormal heart rhythms without needing invasive procedure…

About 13 in 1,000 children are born with heart disease, but current tools struggle to measure how well the heart fills with blood. This study tests a new, ultrafast ultrasound technique that captures images at a very high rate to measure heart stiffness and blood flow. Researcher…

This trial tests whether adding nitric oxide gas to the heart-lung machine during surgery can prevent acute kidney injury in newborns with congenital heart defects. Up to 60% of these babies experience kidney damage after surgery, which can lead to serious complications. The stud…

This study tests whether giving a single dose of an antihistamine (chlorpheniramine) right after heart-lung machine use can prevent sudden low blood pressure caused by blood transfusions in children having heart surgery. Forty children with congenital heart defects will be random…

Researchers are testing whether warming the wrist with a forced-air warmer helps doctors place arterial catheters on the first try in babies and toddlers having heart surgery. The trial includes 126 children aged 2 years or younger. Half receive local warming before the procedure…

This study tests a virtual psychological support program called HeartGPS for mothers whose babies are diagnosed with congenital heart disease before birth. About 210 mothers and their infants will take part, with some receiving the program plus usual care and others only usual ca…

Children having corrective heart surgery through a chest incision often need strong pain medicine. This trial compares two ultrasound-guided nerve blocks, a parasternal intercostal plane block and an erector spinae plane block, both using a mix of bupivacaine and lidocaine. All c…

This study tests whether playing soft music or using a musical mobile can reduce pain and stress in infants when chest tubes are removed after heart surgery. Fifty-four babies aged 2 to 12 months will be randomly assigned to hear music, see a musical mobile, or receive standard c…

This study looks at two ways of giving the pain medicine ketorolac to children after heart surgery: as a steady drip or as shots every few hours. The goal is to see if the steady drip reduces the need for stronger opioid pain medicines. About 166 children aged 3 months to 5 years…

This study tests a methadone-based recovery plan to improve pain control and reduce opioid use in children after heart surgery. About 500 children aged 3 to 18 will be randomly assigned to either the new methadone plan or standard care. The goal is to see if the new approach lowe…

This study tests a 5-week online program called WE BEAT that teaches teens with congenital heart disease skills to handle stress and bounce back from tough times. About 390 teens aged 12-17 will be randomly assigned to the program or usual care, and researchers will measure chang…

This study is testing a smartphone app called MedlyPeds that lets children with heart disease send their weight, blood pressure, and heart rate to their doctors from home. The app also asks about symptoms and sends personalized tips. The goal is to see if the app is easy to use a…

This study looks at two simple breathing exercises—coughing exercises and incentive spirometry (using a plastic device)—to see which helps children aged 6 to 18 recover better after heart surgery. About 99 children will be randomly assigned to one of three groups: coughing exerci…

This study tests a clinical decision support system (CDSS) that helps doctors decide when to remove breathing tubes from children after heart surgery. About 330 children under 12 who have been on a ventilator for at least 48 hours after surgery will take part. The system gives tw…

This study tests whether live, group exercise sessions delivered via video chat can improve fitness in teens (ages 12-19) with certain types of congenital heart disease. 74 participants will either join the remote exercise program or receive standard exercise handouts. The main g…

This study tests an online program called I-InTERACT-North that helps parents of children aged 3-9 with congenital heart disease improve their parenting skills and manage child behavior. About 382 families from SickKids in Ontario will take part. The goal is to see if the program…

This trial tests a home-based exercise bike linked to a video game, designed for kids aged 10-18 with repaired congenital heart disease. Participants will do high intensity interval training three times a week for 12 weeks. The goal is to see if this fun, telemedicine-supported p…

This study tests whether a nerve block called a parasternal plane block can better control pain during heart surgery in children aged 6 months to 7 years. The block is given after anesthesia and uses a numbing medicine (bupivacaine). Researchers will measure pain using a special …

This study tests a program called H-HOPE for babies born with birth defects who need surgery soon after birth. The program includes special care and support to help with feeding, growth, and brain development, while also improving parents' mental health. About 40 babies and their…

This study tests whether a 12-week home-based high intensity interval training program can improve exercise capacity in people aged 12 to 45 with a congenital heart defect that required a surgical connection between the right ventricle and pulmonary artery. Participants are rando…

This study is for children under 6 years old who need heart surgery. It tests a pain medicine called EXPAREL to see if it works well and is safe compared to a standard painkiller. The medicine is given near the surgery area to help with pain after the operation. About 48 children…

This study tests whether a Parent Navigator Program (PNP) helps Latino/x families of babies with congenital heart disease get connected to developmental follow-up services. Forty families will be randomly assigned to either receive support from a parent with lived experience or s…

People born with single-ventricle heart disease often have the Fontan operation, which reroutes blood flow but leaves them with reduced exercise capacity. Researchers at Hacettepe University are measuring lung function and breathing muscle strength alongside treadmill exercise te…

This study aims to develop and test new MRI methods for imaging the heart and blood vessels to improve diagnosis and management of heart disease. It will enroll up to 3,400 adults, including both patients with heart conditions and healthy volunteers. Participants will undergo MRI…

This study tests a special breastfeeding guideline for infants born with congenital heart disease (CHD). Researchers want to see if the guideline helps more mothers breastfeed directly and reduces stress. About 266 mother-infant pairs will take part across multiple hospitals, wit…

This study aims to develop better MRI methods for imaging the heart and brain, and to describe heart diseases using these new techniques. It will also investigate whether gadolinium, a common MRI contrast agent, stays in the body long after use. Up to 5,000 healthy volunteers and…

This study looks at why some adults who had the Fontan procedure as children develop serious liver scarring. Researchers will use blood tests, imaging, and liver biopsies to track changes and find early markers of disease. The goal is to better understand the process and pave the…

This study aims to create a network of biobanks across Italy that collect and store biological samples and health data from people with rare diseases and their families. The goal is to standardize how samples are collected and shared, so researchers can access high-quality materi…

This study aims to create an artificial intelligence (AI) model that can predict complications in children who have a common heart defect called a ventricular septal defect (VSD) repaired with a catheter-based procedure. Researchers will analyze data from over 5,000 children's me…

This study will test new MRI methods to find early signs of heart disease in 1000 adults. Researchers want to see if these scans can detect tiny changes in heart muscle before standard tests do. Participants will have MRI scans and blood work, but no treatment is given. The goal …

This study looks at 174 mothers whose babies were diagnosed with serious heart defects before birth. Researchers will track the mothers' mental health from the third trimester until the baby is one year old, and then test the babies' brain development. The goal is to understand i…

22q11.2 deletion syndrome can cause heart defects, facial differences, and learning challenges, but its severity differs widely from person to person. This study analyzes DNA from 1,000 people with the deletion to identify genetic variations that might influence how the disorder …

This study tests whether a wireless sensor placed on the forehead can accurately measure oxygen levels in the brains of infants in the neonatal intensive care unit (NICU). The wireless device is compared side-by-side with the standard wired monitor in 20 newborns with conditions …

This study screens children and adolescents aged 5 to 18 who have chronic conditions like congenital heart disease, inflammatory bowel disease, celiac disease, or rheumatic diseases for lipid metabolism disorders. Participants provide a blood sample and complete a questionnaire a…

This study tests a new pulse oximeter worn on the abdomen, designed to measure oxygen levels in infants with congenital heart disease. Researchers compare its accuracy against standard fingertip monitors and direct blood measurements. The device also includes features to reduce e…

This registry tracks 2,000 adults with congenital heart disease who are on the waiting list for a heart or heart-lung transplant. The goal is to understand why some patients get worse or die while waiting, while others improve enough to be removed from the list. By collecting dat…

This study follows 450 babies born with serious heart defects to find early signs of developmental delays by 6 months of age. Researchers want to understand why over half of these children face learning, thinking, or behavior challenges later in life. The goal is to identify risk…

This study aims to collect DNA samples and medical information from 2,000 people with heterotaxy (a condition where organs are arranged abnormally) and related heart defects, along with their family members. Researchers hope to identify the genetic causes of these conditions, whi…

This study looks at oxygen levels in the kidneys of premature babies born before 32 weeks who have a heart condition called patent ductus arteriosus (PDA). Researchers want to see how kidney oxygen relates to the severity of the heart condition and whether it can predict kidney i…

This study will use a new type of cardiac MRI to look at the heart's microscopic structure in 1,000 people—both healthy volunteers and those with various heart conditions. The goal is to see if this advanced imaging can detect early signs of heart damage better than standard test…

This registry is following 5,000 adults in Switzerland who were born with heart defects. The goal is to collect data on their long-term health, including complications and treatments. By tracking these patients over time, researchers hope to better understand the challenges they …

This study follows 845 people who previously received a Melody valve implant to treat congenital heart disease. Researchers will track serious events like death, repeat surgery, or infection over many years. The goal is to understand how well the valve performs long-term after it…

This study at Mayo Clinic enrolls 50 healthy adults to provide comparison data for the Adult Congenital Heart Disease Registry. Participants undergo an MRI and a test measuring blood pressure in the lungs during exercise. The goal is to better understand heart and lung function i…

This study uses small pieces of heart tissue removed during necessary surgery in children with congenital heart disease. Researchers want to understand how calcium controls heart cell contraction and how infant heart cells differ from adult ones. They also aim to improve lab-grow…

This study looks at ways to help teenagers and young adults with congenital heart disease (CHD) switch from pediatric to adult doctors. Researchers will compare education led by nurses versus doctors to see which works better. About 450 people with CHD, their supporters, and prov…

This study aims to find genes that make some people with congenital heart defects develop a serious lung condition called pulmonary arterial hypertension (PAH). Researchers will analyze DNA from blood samples of 21 patients with heart defects who also have PAH. The goal is to ide…

This study looks at whether brain wave tests (EEG) done before and after heart surgery in babies under 1 year old can predict later learning or behavior problems, such as autism or ADHD. About 50 infants will be followed to age 2. The goal is to find early warning signs so that c…

This study tests a new, lightweight ultrasound device called NeoDoppler that can be gently placed on a newborn's soft spot (fontanelle) to continuously measure blood flow in the brain. Researchers will enroll 180 preterm and full-term infants, including those with conditions like…

This study follows 52 children with cyanotic congenital heart disease and a single working heart chamber (univentricular heart) who undergo a series of surgeries ending with the Fontan procedure. Researchers will compare outcomes like survival, complications, and quality of life …

This study looks at infants having heart surgery, where the thymus gland is often fully removed to access the heart. The thymus helps build the immune system early in life. Researchers want to see if removing only part of the thymus keeps the immune system stronger and reduces in…

This observational study will analyze data from 3,000 people with complex congenital heart disease who have had or will have heart surgery in China. Researchers aim to identify key risk factors affecting recovery and build a quality control system to improve surgical care. Partic…

This study tests whether a personalized lung volume optimization maneuver can improve heart and lung function in children on ventilators. It includes two groups: children recovering from heart surgery and those with severe respiratory failure. Researchers will adjust ventilator p…

This study follows 10,000 children with congenital heart disease who need surgery for non-heart issues. Researchers want to learn what complications occur and how hospitals use resources. The goal is to create better risk predictions and improve care for these patients.

This study aims to find the genetic causes of congenital heart disease, the most common birth defect. Researchers will collect blood samples from 5,000 people with the condition and their family members. By analyzing their DNA, they hope to discover new genes that contribute to h…

This study will follow over 1,200 children aged 3 to 11 who were born with critical heart defects and had heart surgery in their first three months. Researchers want to find out how many of these children develop learning, attention, or behavioral problems, and why. They will use…

This study looks at how growing up with a heart condition might increase the risk of post-traumatic stress disorder (PTSD). Researchers will survey 1,000 adults with congenital heart disease to find out which experiences—like past surgeries or bullying—are linked to PTSD. They wi…

This study is building a large collection of blood samples and health information from 5,000 adults with congenital heart disease and related conditions. Researchers will use this data to better understand how these diseases work and what affects patient health. No treatments or …

This study uses special MRI scans to look at how the heart and muscles work together during exercise in children with heart disease or those who have had a heart transplant. Researchers want to learn more about what affects fitness in these kids. About 20 children aged 10 to 18 w…

This study examines whether special pacemakers can effectively treat a common type of fast heart rhythm (atrial tachycardia) in people born with heart defects. Researchers will review medical records from up to 300 patients over 10 years to see if the pacemaker reduces the need f…

This study looks at whether a structured physical activity program can improve thinking and learning in children who had heart surgery. Researchers will compare these children to those having other surgeries and healthy kids. The goal is to see if exercise helps with memory, atte…

This study is testing a new, non-invasive monitor (fetal magnetocardiography) to detect hidden heart problems in high-risk pregnancies that might lead to fetal death. Researchers will study 30 pregnant women with conditions like congenital heart disease or twin pregnancy. The goa…

This study looks at how well the heart works during exercise compared to at rest in people with congenital heart disease. Researchers will use a special test during a routine heart catheterization to measure blood flow and pressures. The goal is to find out if exercise can uncove…

This study will collect leftover blood samples from 10 newborns with severe heart defects who have surgery at Boston Children's Hospital. Researchers want to understand why these babies are more likely to develop dangerous blood clots after surgery. They will look at tiny molecul…

This study uses a safe, radiation-free device called electrical impedance tomography (EIT) to take pictures of the lungs in infants, children, and young adults up to age 25. Researchers will compare images from patients with chronic lung or heart conditions to healthy controls to…

This study looks at how changes in preoperative care affect anxiety in 100 children with congenital heart disease who need surgery or catheterization. Researchers will measure stress levels using questionnaires and scales, and also get feedback from parents and care teams. The go…

This international registry is tracking 400 adults with congenital heart disease who are taking SGLT2 inhibitors, a type of diabetes medication that also benefits the heart. Researchers want to see how these drugs are being prescribed, how well they are tolerated, and whether the…

This study looks at whether pulse oximeters—the clips placed on fingers to measure oxygen levels—work equally well for children with different skin tones who have congenital heart disease. Researchers will enroll 92 children under 18 undergoing heart surgery and compare the oxime…

This study tests whether a wrist-worn device can help monitor pregnant women with congenital heart disease. Researchers will track heart rhythms and other data from 50 participants to see if the wearable can detect early signs of trouble. The goal is to improve care and reduce th…

This study aims to understand why people with tetralogy of Fallot and other congenital heart diseases experience shortness of breath, palpitations, and changes in heart structure. Researchers will use remote heart rhythm monitors and imaging to track 300 participants over two yea…

This study tests a digital app called Empower My Congenital Health (EmpowerMyCH) designed to help adults with congenital heart disease navigate the healthcare system. Researchers will enroll 1,000 participants to see if the app is easy to use, acceptable, and helps patients feel …

This study looks at leftover blood samples from 100 patients having heart surgery to see how certain immune cells (monocytes) change during the procedure. The goal is to understand links between inflammation and blood clotting risks. No new treatments are being tested; it is pure…

This study is looking at a new blood marker called sST2 to see if it can better detect heart failure in children after congenital heart surgery. Researchers will measure sST2 levels in 225 children under 18 during and after surgery, and at a follow-up 9-12 months later. They will…

This study tests a new 3D ultrasound technique (Ventripoint) to see if it can accurately measure heart size and function in children and young adults born with a single ventricle. Researchers will compare the 3D ultrasound to standard echocardiograms and cardiac MRIs. The goal is…

This study looks at whether using a 3D-printed model of a child's heart helps surgeons plan a procedure to place a mechanical pump (VAD) in children with congenital heart disease and heart failure. About 36 children weighing over 3 kilograms will take part. The goal is to see if …

This study creates a registry for 500 people with congenital heart disease (CHD) and their caregivers. Participants share their medical history to help researchers understand the disease better and design future clinical trials. Unlike a typical registry, members will actively gu…

This study explores whether an advanced practice nurse can effectively screen for neurodevelopmental disorders (like learning or behavior problems) in children aged 1 to 5 who have congenital heart disease. Researchers will compare the nurse's screening results with a full assess…

This study aims to see if an online screening tool can help find mental health problems in children aged 5-17 who were born with heart defects. Researchers will ask parents and children to complete questionnaires and check if they meet criteria for psychiatric diagnoses. The goal…

This study follows 150 fetuses diagnosed with a rare heart condition called pulmonary atresia with intact ventricular septum. Researchers will track their health before and after birth to develop a model that predicts which babies will need simpler versus more complex surgeries. …

This study is checking if pulse oximeters—the clip-on devices that measure oxygen levels—are equally accurate in children with different skin colors. Researchers will compare readings from the device to a precise blood test in 650 children undergoing heart procedures. The goal is…