Congenital heart malformation

This study tests whether the Butantan-Dengue vaccine is safe and works well in people aged 12–59 with autoimmune rheumatic diseases (like rheumatoid arthritis or lupus) who are stable on low or no immune-suppressing drugs. Participants receive one vaccine dose and are monitored f…

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 compares two ways to place stents in the left main coronary artery when there is a blockage at the opening of a branch. One method places a stent only in the blocked branch, while the other extends a stent from the main artery into the branch. Researchers will track 10…

This phase 3 trial is testing whether atorvastatin, a common cholesterol drug, is safe and can reduce inflammation in children with Kawasaki disease who also have coronary artery abnormalities. The study will enroll 9 children and give them different doses of atorvastatin for 6 w…

This study tests two types of branch endografts (Zenith t-Branch and Terumo Arch Branch) to treat aortic aneurysms in the chest and abdomen. The devices are placed inside the aorta to reinforce the weakened vessel wall and keep blood flowing to vital organs. Researchers will trac…

This study tests whether giving two steroids (hydrocortisone and fludrocortisone) to high-risk patients before heart surgery can lower the chance of serious complications like kidney injury and lung problems. The trial will include 196 adults with a EuroSCORE II above 4% who are …

This small pilot study is testing whether giving a second treatment with the Nectero EAST system is safe and helpful for people with abdominal aortic aneurysms (a bulging blood vessel in the belly). Ten adults who already had one treatment will get a repeat procedure. The goal is…

This study tests whether a high-calorie formula called Fortini helps babies born with a serious heart condition (single ventricle) grow better after their first heart surgery. About 100 infants will be randomly assigned to receive either Fortini or standard high-calorie formula a…

This study tests whether dapagliflozin, a drug used for diabetes and heart failure, can lower vein pressure in adults with a failing Fontan circulation. About 27 participants will take the drug or a placebo for 3 months. The goal is to see if it helps the heart pump blood more ea…

This study is testing a device called a valved graft, which replaces both the aortic valve and the ascending aorta in one surgery. It includes 260 people with aortic valve disease, an enlarged aorta, or aortic dissection. The goal is to see how safe and effective the device is by…

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 study looks at whether people with Takayasu arteritis, a rare blood vessel disease, can safely stop taking biologic medications after being in remission for a long time. About 40 participants who have been on biologics for at least 3 years and have no active disease will slo…

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 is testing a less invasive treatment for a serious tear in the main artery near the heart, specifically for people who are too high-risk for open-heart surgery. About 149 participants will receive a stent placed through a blood vessel to repair the tear. Researchers 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 two drugs—bosentan and dapagliflozin—can improve blood vessel function in people with large vessel vasculitis, a condition that damages arteries and raises the risk of heart attacks and strokes. Sixty adults with stable disease will take both drugs for 6 …

This early-stage trial tests whether the beta-blocker propranolol can stimulate heart muscle cell growth in infants born with Tetralogy of Fallot, a serious heart defect. Forty infants under 60 days old will receive propranolol, and researchers will measure new heart muscle cells…

This study tests whether the drug udenafil can improve exercise ability in adolescents aged 12-18 who have had the Fontan procedure for single ventricle heart disease. Participants will take udenafil or a placebo daily for 26 weeks, and their exercise capacity will be measured. T…

This study is for babies, infants, and small children who have narrowed arteries in or near the heart. Doctors will use a special tiny stent to open the blockage and improve blood flow. The goal is to see how well the stent works and to track any side effects in everyday medical …

This study tests a new surgical technique called B-SAFER for people with complex aortic disease affecting multiple segments of the aorta. The procedure combines open surgery with a modified stent graft to repair the aortic arch and descending aorta in one operation. Researchers a…

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 looks at patients with an ascending aorta that is enlarged (5.0 to 5.4 cm) but not yet at the traditional surgery threshold. Half will have early surgery to replace the aorta, and half will be closely monitored. Researchers will compare death rates and dangerous aortic…

This study compares two surgical timings for babies born with Tetralogy of Fallot, a serious heart defect. One group gets corrective surgery within 28 days of birth, the other at the usual 3-6 months. Researchers will track deaths, reoperations, and recovery to see if earlier sur…

This study aims to improve how doctors diagnose a rare heart condition where a coronary artery starts in the wrong place (AAOCA), which can cause sudden cardiac death in young athletes. Researchers will use artificial intelligence and 3D computer models to analyze CT scans and pr…

This early-phase study tests whether placing amiodarone directly into the sac around the heart during open-chest surgery can prevent a common and serious irregular heartbeat called atrial fibrillation. About 63 adults aged 20-85 having bypass or valve surgery will receive this tr…

This study tests whether wearing compression garments on the legs can increase the amount of blood the heart pumps during exercise in adults with Fontan circulation. Twenty participants will undergo exercise tests with and without the garments, and a subset will wear them for two…

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 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 tests whether a cardiac rehabilitation program can help adults with Fontan failure walk more each day and improve their exercise ability, frailty, and quality of life. Researchers will compare the rehab group to those receiving usual care. The trial aims to enroll 50 p…

This study tests whether a gentle brain stimulation technique called tACS, used at home for 5 days a week over 4 weeks, can improve memory and thinking in 40 young people aged 14-25 with 22q11.2 deletion syndrome. The stimulation is personalized based on each participant's MRI an…

This study follows up to 4,000 people with vasculitis (a group of diseases that cause blood vessel inflammation) and healthy volunteers over many years. Researchers collect blood, urine, imaging, and genetic samples to learn how the disease develops and changes. The goal is to fi…

This study is creating a decision aid for people with a rare heart condition called right anomalous aortic origin of a coronary artery (R-AAOCA). The condition raises the risk of sudden cardiac death, but the best management—surgery or careful observation—isn't clear. The aid wil…

This study looks back at medical records of 105 people who had a minimally invasive surgery called BEVAR to treat complex aortic aneurysms. Researchers want to see if two types of stent grafts (TUVA BX and iCover) are safe and work well. No new treatments are given; the study jus…

This pilot study tests whether a special MRI technique can measure wall shear stress—the force of blood against vein walls—in the pulmonary veins of infants. These veins carry blood from the lungs to the heart, and narrowing them (pulmonary vein stenosis) is a life-threatening co…

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…

This study looks at how inflammation and energy use in the aorta differ between people with a bicuspid versus tricuspid aortic valve who have an ascending aortic aneurysm. Researchers will analyze blood and discarded surgical tissue to find molecular markers that could lead to be…

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 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 aims to measure how well infants' hearts can make new muscle cells, especially in those with a heart condition called Tetralogy of Fallot. Researchers will use a special imaging technique on heart tissue that is normally removed and thrown away during surgery. The goal…

This study aims to learn how well heart scans (MRI, ultrasound, PET) can detect and predict outcomes in people with suspected or known inflammatory heart diseases. Researchers will follow 5,000 adults for one year to see how often heart involvement is confirmed and how it affects…

This study tests a handheld camera that looks at tiny blood vessels in children undergoing heart surgery for certain birth defects. Standard monitors only check large vessels, but this camera may reveal hidden problems. About 40 children will participate to see if the camera help…

This study compares using ultrasound versus an age-based formula to choose the correct breathing tube size for children aged 3 months to 8 years with single ventricle heart conditions. The goal is to see which method leads to fewer breathing tube placement attempts and less post-…

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 global registry is collecting information from 1,000 people with Takayasu's arteritis, a rare disease that inflames and narrows large arteries. Researchers will analyze patients' symptoms, lab results, imaging, and treatments to see how the disease behaves and is managed aro…

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 is re-examining 1,400 adults in Stockholm to find early signs and risk factors for heart, lung, and liver diseases. Participants will get advanced scans, blood tests, and questionnaires. The goal is to better understand how these diseases develop and how to predict the…

This study follows 200 adults who have had or will have a procedure to fix a leaky or narrowed valve in the right side of the heart. Researchers track survival, unplanned hospital stays, and heart function using blood tests and ultrasound. The goal is to learn which treatments wo…

This study looks at tissue removed from patients with enlarged aortas (aneurysms) during surgery. Researchers want to measure how strong the tissue is and see if that relates to the size or thickness of the aorta. The goal is to better understand what makes an aneurysm likely to …

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 observational study aims to better understand the mechanical properties of the aortic wall in patients with aortic aneurysms or dissection. Researchers will measure tissue strength from samples taken during surgery and compare them to samples from patients without aortic dis…

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 compares two surgical techniques for repairing a chronic ascending aortic aneurysm: the traditional full sternotomy (cutting through the breastbone completely) and a less invasive J-shaped mini-sternotomy (a smaller cut). Researchers will track early and late outcomes …

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 tracks the pregnancy experiences of women with vasculitis, a group of rare diseases causing blood vessel inflammation. Researchers will use online surveys to understand how vasculitis affects pregnancy and what outcomes occur. The goal is to gather information to help …

This study collects tissue samples from 1,000 people with various forms of vasculitis, a group of rare inflammatory blood vessel diseases. Researchers will analyze the samples alongside clinical data to identify genes that increase risk and to spark new ideas for diagnosis and tr…

This study uses two online questionnaires to learn about the experiences of people with Takayasu arteritis and how doctors manage the condition. About 50 patients and an unspecified number of physicians in the UK will share their views on symptoms, treatment priorities, and unmet…

This study collects DNA samples and medical information from 1,000 people with various forms of vasculitis (blood vessel inflammation). Researchers will analyze the data to identify genes that increase the risk of developing these severe diseases. The goal is to better understand…

This study is looking at 200 people who need surgery for an ascending aortic aneurysm. Researchers will use MRI scans before surgery and test the removed tissue in the lab to learn more about the aorta's strength and flexibility. The goal is to better understand when surgery is n…

This study looks at how two rare diseases that cause blood vessel inflammation—Takayasu arteritis and Behçet's disease—affect physical strength, breathing, daily function, and emotional well-being. Researchers will compare 30 participants (patients and healthy volunteers) using s…

This study is testing a device called Electrical Impedance Tomography (EIT) that uses electrodes to create images of the lungs without radiation. Researchers want to see if it can provide useful information about lung function in children with chronic respiratory diseases, includ…

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 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 follows 150 people with Takayasu's arteritis that also affects the lung arteries. Researchers will track their health over time, including how far they can walk in six minutes and their risk of death. The goal is to better understand the disease and its long-term outlo…

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 observational study is measuring arterial stiffness in 250 people with genetic conditions that cause aortic aneurysms. Researchers want to see if stiffness can help predict who is at higher risk. Participants undergo a simple, non-invasive test of blood pressure and artery s…