[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"congenital-heart-disease\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:congenital-heart-disease":28},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,99,0,25,[9,48,76,108,134,160,193,222,246,278,302,330,356,386,405,431,457,475,501,536,567,589,619,639,664],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100053335","interoceptive-intervention-for-congenital-heart-disease-100053335",false,"NCT07697755","Interoceptive Intervention for Congenital Heart Disease","A Randomised Controlled Feasibility Trial Exploring an Interoceptive-Based Intervention in Patients With Congenital Heart Disease","Inclusion Criteria:\n\n* Participants must be aged 18 years or older\n* Under the care of the Scottish Adult Congenital Cardiac Service (SACCS) at the Golden Jubilee University National Hospital (GJUNH)\n* Be able to understand and communicate in English\n* Provide informed consent\n* Access and use a device compatible with Microsoft Teams\n* Be able to commit to the duration of the group programme\n\nExclusion Criteria:\n\n* Individuals with current suicidal ideation\n* Individuals with comorbid alcohol or substance use disorders\n* Individuals with a diagnosed learning disability\n* Individuals with a severe and enduring mental health condition (e.g., personality disorder or psychosis)\n* Individuals with hearing, visual and cognitive difficulties preventing safe online group participation\n* Individuals who are currently on a surgical or transplant waiting list\n* Individuals who are receiving intensive psychological treatment (e.g., trauma processing or crisis support)","ALL","18 Years",{"count":20,"type":21},32,"ESTIMATED","INTERVENTIONAL",[24],"NA","Adults living with congenital heart disease (CHD) commonly experience physical symptoms alongside emotional and social challenges, which can affect wellbeing and health-related quality of life. Access to psychological services varies, and evidence to guide the development and delivery of psychological interventions for this population is still emerging.\n\nInteroceptive-based approaches focus on increasing awareness of and responding adaptively to internal bodily sensations, such as breathing, heart rate and fatigue. These approaches have shown benefits in other long-term health conditions but have not yet been studied in adults with CHD. This study will evaluate the feasibility, acceptability, and preliminary effects of a newly adapted online, skills-based group programme for adults with CHD.\n\nThirty-two participants will be recruited through the Scottish Adult Congenital Cardiac Service and randomly allocated to one of two cohorts: Cohort 1 (Immediate Intervention) and Cohort 2 (Delayed\u002FWaitlist Intervention). The group programme will consist of eight online sessions delivered by a Principal Clinical Psychologist and a Trainee Clinical Psychologist. Weekly sessions will explore the relationship between interoception and key areas relevant to living with CHD, including emotions, behaviours, and physical symptoms. Group discussions and exercises will focus on increasing awareness and understanding of internal bodily sensations, developing strategies for responding to interoceptive cues and using bodily information to guide behaviours and everyday activities.\n\nParticipants will complete online questionnaires before and after the intervention assessing interoception, anxiety, depression and health-related quality of life. Participants will also provide feedback regarding the acceptability and perceived usefulness of the programme. Participation is voluntary, and participants may withdraw at any time without affecting their clinical care. Appropriate emotional support will be available should participants experience distress related to the group materials or discussions.\n\nFindings from this feasibility randomised controlled trial will inform further refinement of the group programme, assess the acceptability and feasibility of study procedures, provide estimates of recruitment, retention and outcome variability, and support the design and sample size calculation of a future definitive trial. The findings may also contribute to the enhancement of psychological support for adults with CHD and be disseminated through scientific publications and conference presentations.",[27,28],"Interoception","Congenital Heart Disease",[30,27,31,32,33,34],"Adult Congenital Heart Disease","Psychological Intervention","Group Intervention","Pilot Study","Feasibility Randomised Controlled Trial","NOT_YET_RECRUITING","2026-07-08",{"date":38,"type":39},"2026-07-13","ACTUAL",{"date":41,"type":21},"2026-07",{"date":43,"type":21},"2026-12",{"name":45,"class":46},"University of Glasgow","OTHER",1,{"id":49,"slug":50,"hasResults":12,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":54,"eligibilityCriteria":55,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":56,"targetDuration":58,"studyType":59,"phases":4,"briefSummary":60,"conditions":61,"keywords":4,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":47},"100427656","the-patients-presenting-with-congenital-heart-disease-register-artoria-r-100427656","NCT04848844","The PAtients pResenTing With COngenital HeaRt DIseAse Register (ARTORIA-R)","The PAtients pResenTing With COngenital HeaRt DIseAse Register (ARTORIA-R): A Global Register to Investigate Factors Associated With Morbidity and Mortality in Adult Patients With Congenital Heart Disease (ACHD) on the Waiting List for Heart or Heart\u002FLung Transplantation","ARTORIA-R","Inclusion Criteria:\n\n1. The patient has to be listed as an adult transplant candidate in the country the data is obtained with an age ≥18 years\n2. The patient has to have a congenital heart defect or an inherited cardiomyopathy (specific; hypertrophic cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy or non-compaction cardiomyopathy) which is often included into the category ACHD\n3. Data is obtained from the first evaluation for listing or listing for heart-only or heart-combined organ transplantation\n4. Transfer of anonymised data\n5. The institution\u002Forganization agrees to the memorandum how data is managed, and scientific cooperation is planned between all institutions\n\nExclusion Criteria:\n\na. The patient is listed for a second heart transplantation (retransplantation)",{"count":57,"type":21},2000,"30 Years","OBSERVATIONAL","Advances in surgical and medical care have led to improved outcomes in patients with congenital heart disease (CHD). As a consequence, the majority of patients nowadays survives to adulthood (adults with CHD, that is, adult CHD \\[ACHD\\]) with good quality of life. Despite the surgical success, the morbidity and mortality of ACHD is higher than in the general population and is linked to the development of heart failure (HF) in adulthood.\n\nHF occurs in approximately 25% of patients with ACHD, even in those patients in whom the congenital mal-formation has been corrected successfully in childhood. The time course and presentation are heterogeneous owing to variable congenital malformation and limitation of treatment options. ACHD with an anatomic right ventricle as the systemic ventricle (e.g., atrial switch operation in patients with transposition of the great arteries \\[TGAs\\]) and those with a functional single ventricle (e.g., Fontan circulation) appear to be at higher risk of developing HF. Young age at initial corrective surgery-often in the first 2 years of life-and lack of specific medical therapies can contribute to a high and early demand for heart transplantation in patients with ACHD.",[28,62,63,64,65],"Heart Failure","Transplant; Complication, Failure","Arrythmia","Ventricular Dysfunction","RECRUITING","2026-06-28",{"date":69,"type":39},"2026-07-01",{"date":71,"type":39},"2020-09-02",{"date":73,"type":21},"2030-07-30",{"name":75,"class":46},"Universitätsklinikum Hamburg-Eppendorf",{"id":77,"slug":78,"hasResults":12,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":82,"eligibilityCriteria":83,"healthyVolunteers":12,"sex":17,"minAge":84,"maxAge":85,"enrollmentInfo":86,"targetDuration":4,"studyType":59,"phases":4,"briefSummary":88,"conditions":89,"keywords":93,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":47},"100644448","wearable-assessment-of-thoracic-cardiac-health-and-exercise-performance-trial-prospective-100644448","NCT07663799","Wearable Assessment of Thoracic, Cardiac Health and Exercise Performance Trial Prospective","Wearable Assessment of Thoracic, Cardiac Health and Exercise Performance Trial Prospective (WATCH-XP)","WATCH-XP","Inclusion Criteria:\n\n* Age 20 to 70 years old\n* Ability to provide informed consent\n* History of the following cardiovascular conditions:\n* Adult congenital heart disease\n* Pulmonary hypertension\n* Heart failure\n* Coronary artery disease\n* Athletes undergoing cardiovascular assessment\n\nExclusion Criteria:\n\n* Contraindication for undergoing physical exertion including cardio-pulmonary exercise testing (CPX) and 6-minute walk test (6MWT)\n* Pregnancy\n* Known allergy to components of the investigational product","20 Years","70 Years",{"count":87,"type":21},20,"Wearable health technology, particularly smartwatches, has revolutionized personal health monitoring by enabling continuous, non-invasive tracking of various physiological parameters. The potential applications of these devices in cardiology are extensive, but it is crucial to validate their accuracy against established medical-grade devices.\n\nThe Apple Watch Series 9 (Apple, USA) exemplifies the capabilities of modern smartwatches, offering a wide range of health tracking features. These include heart rate monitoring, detection of irregular heart rhythms suggestive of atrial fibrillation, electrocardiogram recording, blood oxygen level measurement, and comprehensive mobility metrics (including VO2 max, six-minute walk distance, walking speed, step length, double support time, and walking asymmetry). Many of these parameters are highly relevant for cardiovascular patients, potentially aiding in disease progression monitoring and adverse event prediction. However, there is a lack of comprehensive validation studies for these devices in specific cardiovascular disease populations.\n\nThis investigator-initiated, prospective observational study will consist of two phases: a training phase which involves 50 participants and a prospective validation phase which involves 20 participants. The study aims to validate smartwatch-based assessments using medical-grade devices and techniques. The study will focus on adult patients with congenital heart disease, pulmonary hypertension, heart failure, and coronary artery disease, as well as athletes undergoing cardiovascular assessment. By comparing smartwatch data with established clinical measurements, we seek to determine the reliability and potential clinical utility of these wearable devices in diverse cardiovascular contexts. Anonymized smartwatch data collected during the two phases will be published to a publicly registry to facilitate further research. This research will help bridge the gap between consumer-grade wearable technology and clinical practice in cardiology.",[28,90,62,91,92],"Pulmonary Hypertension","Coronary Heart Disease (CHD)","Apple Watch",[94,95,96,97,98],"apple watch","congenital heart disease","heart failure","coronary heart disease","pulmonary hypertension","2026-06-16",{"date":101,"type":39},"2026-06-23",{"date":103,"type":21},"2026-08-01",{"date":105,"type":21},"2028-12-31",{"name":107,"class":46},"The University of Hong Kong",{"id":109,"slug":110,"hasResults":12,"nctId":111,"briefTitle":112,"officialTitle":112,"acronym":4,"eligibilityCriteria":113,"healthyVolunteers":114,"sex":17,"minAge":115,"maxAge":116,"enrollmentInfo":117,"targetDuration":4,"studyType":22,"phases":119,"briefSummary":120,"conditions":121,"keywords":122,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":125,"startDateStruct":127,"completionDateStruct":129,"leadSponsor":131,"locationsCount":133},"100488261","dynamic-critical-congenital-heart-screening-with-addition-of-perfusion-measurements-100488261","NCT05637814","Dynamic Critical Congenital Heart Screening With Addition of Perfusion Measurements","Inclusion Criteria:\n\n* Age \\\u003C 22 days\n* Fetuses suspected to have congenital heart disease\n* Newborns with suspected\u002Fconfirmed critical congenital heart disease\n* Asymptomatic newborn undergoing SpO2 screening for CCHD\n\nExclusion Criteria:\n\n* Echocardiogram completed prior to enrollment as the newborn would then no longer be considered \"asymptomatic undergoing SpO2 screening for CCHD\"\n* For Newborns with confirmed\u002Fsuspected congenital heart disease (CHD): a) Patent ductus arteriosus and\u002For atrial septal defect\u002Fpatent foramen ovale without other defects, b) Corrective cardiac surgical or catheter intervention performed before enrollment or c) Current infusions of vasoactive medications other than prostaglandin therapy.",true,"0 Minutes","21 Days",{"count":118,"type":21},320,[24],"The purpose of this study is to implement and externally validate an inpatient ML algorithm that combines pulse oximetry features for critical congenital heart disease (CCHD) screening.",[28],[123,124],"Machine Learning Algorithm","Pulse Oximetry",{"date":126,"type":39},"2026-06-18",{"date":128,"type":39},"2023-08-17",{"date":130,"type":21},"2027-12-31",{"name":132,"class":46},"University of California, Davis",3,{"id":135,"slug":136,"hasResults":12,"nctId":137,"briefTitle":138,"officialTitle":139,"acronym":4,"eligibilityCriteria":140,"healthyVolunteers":12,"sex":17,"minAge":141,"maxAge":18,"enrollmentInfo":142,"targetDuration":4,"studyType":22,"phases":144,"briefSummary":145,"conditions":146,"keywords":148,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":153,"lastUpdatePostDateStruct":154,"startDateStruct":155,"completionDateStruct":156,"leadSponsor":158,"locationsCount":47},"100559457","tailored-mgso4-supplementation-to-reduce-complications-in-pediatric-heart-surgery-100559457","NCT06564376","Tailored MgSO4 Supplementation to Reduce Complications in Pediatric Heart Surgery","Individually Tailored MgSo4 Supplementation to Reduce Cardiac and Renal Complications in Pediatric Heart Surgery","Inclusion Criteria:\n\n* Children undergoing cardiac surgery utilizing cardiopulmonary bypass\n\nExclusion Criteria:\n\n* Children undergoing cardiac surgery without cardiopulmonary bypass\n* Children with Renal disease\n* Children with pre-existing arrhythmia\n* Children on anti-arrhythmia medication","0 Years",{"count":143,"type":21},96,[24],"Lay Summary\n\nThis study tests two ways of measuring blood magnesium after heart surgery. Children who need heart surgery may have heart and kidney problems after surgery. The right amount of magnesium in blood reduces this risk. This study will test the best way to measure magnesium. This will let doctors choose the right dose of MgSO4. MgSO4 is a magnesium supplement. Taking MgSO4 after heart surgery helps children. For each child, it is best to personalize MgSO4 dose. This is based on the amount of magnesium in blood. This study will test two ways of personalizing MgSO4 dose.\n\nIn the blood, there are two kinds of magnesium. Usually, blood magnesium tests measure both forms together. This does not say anything about active magnesium. This study will measure the two forms separately. Then, MgSO4 will be given based on either the active or whole magnesium. Measuring active magnesium is good. Active magnesium levels change faster than total. That means active magnesium tests may better protect children. Also, active magnesium has more of an impact on heart and kidney function. Focusing on the active form will help these organs stay healthy.\n\nTo test how well the MgSO4 is working, heart and kidneys will be examined. After surgery, certain harmful heart rhythms can occur. The types and number of harmful rhythms will be studied. Kidney problems can also happen after heart surgery. Kidney health will be studied. To help understand how active magnesium works, further tests will be done. These tests will look for evidence of poor health in the cells that make up the heart, kidney, and blood.",[147,64,28],"AKI - Acute Kidney Injury",[149,150,151,152],"Acute Kidney Injury","Arrhythmias","Congenital heart surgery","Cardiopulmonary bypass","2026-06-12",{"date":99,"type":39},{"date":103,"type":21},{"date":157,"type":21},"2029-06",{"name":159,"class":46},"West Virginia University",{"id":161,"slug":162,"hasResults":12,"nctId":163,"briefTitle":164,"officialTitle":165,"acronym":166,"eligibilityCriteria":167,"healthyVolunteers":12,"sex":17,"minAge":168,"maxAge":18,"enrollmentInfo":169,"targetDuration":4,"studyType":22,"phases":171,"briefSummary":172,"conditions":173,"keywords":175,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":185,"lastUpdatePostDateStruct":186,"startDateStruct":188,"completionDateStruct":189,"leadSponsor":191,"locationsCount":47},"100637735","exergame-based-physical-activity-promotion-for-children-and-adolescents-with-congenital-heart-disease-100637735","NCT07593118","Exergame-Based Physical Activity Promotion for Children and Adolescents With Congenital Heart Disease","An Exergame-Based Physical Activity Promotion Intervention for Children and Adolescents With Congenital Heart Disease: A Multiple-Baseline Single-Case Experimental Design Study","ExPACE-CHD","Inclusion Criteria:\n\n1. aged 8-18 years, with a confirmed diagnosis of congenital heart disease and a history of cardiac surgery or catheter-based intervention;\n2. at least 3 months since the most recent surgery or intervention, with a clinically stable condition and no planned reintervention in the near future;\n3. deemed by a pediatric cardiologist to be suitable for regular physical activity or low-to-moderate to moderate-to-vigorous physical activity;\n4. presenting with insufficient physical activity and\u002For impaired exercise capacity, defined by at least one of the following: failure to meet the recommended physical activity level for children and adolescents (ie, an average of 60 minutes of moderate-to-vigorous physical activity per day), objectively impaired exercise capacity (eg, peak oxygen uptake \\\u003C80% of predicted and\u002For anaerobic threshold \\\u003C55% of predicted), or reduced exercise tolerance indicated by the 6-minute walk test, physical fitness assessment, or clinical exercise evaluation;\n5. having basic cognitive and communication abilities sufficient to understand instructions and complete questionnaires, trial sessions, and training tasks;\n6. willingness of both the child and the guardian to participate, with written informed consent obtained;\n7. availability of basic family conditions to support intervention delivery, including access to smart devices and\u002For game equipment, internet access, and at least one caregiver able to provide support.\n\nExclusion Criteria:\n\n1. clear contraindications to exercise, such as uncontrolled arrhythmia, overt heart failure, severe pulmonary hypertension, or recent hemodynamic instability;\n2. severe comorbidities that substantially interfere with exercise performance, such as serious neurological disorders, severe musculoskeletal disorders, or other conditions markedly limiting physical activity;\n3. participation within the previous 3 months in another systematic intervention likely to substantially influence physical activity or exercise capacity;\n4. any condition, as comprehensively judged by the research team, that may affect participant safety, intervention implementation, the quality of physical activity monitoring data, or completion of questionnaires or follow-up, including refusal to wear the monitoring device, refusal to complete follow-up, or evident risk of poor adherence.","8 Years",{"count":170,"type":21},13,[24],"The goal of this clinical trial is to learn whether a Nintendo Switch-based exergame physical activity program can help children and adolescents with congenital heart disease increase their physical activity. It will also learn about the safety, acceptability, and feasibility of this program. The study will include children and adolescents aged 8 to 18 years who have congenital heart disease, have received surgical or interventional treatment, and are clinically stable.\n\nThe main questions it aims to answer are:\n\nDoes the exergame-based program increase the amount of time participants spend in moderate-to-vigorous physical activity each day? Is the exergame-based program safe, acceptable, and feasible for children and adolescents with congenital heart disease?\n\nAll participants will receive the same exergame-based physical activity program. Researchers will use different baseline observation periods to help understand whether changes in physical activity happen after the program starts.\n\nParticipants will:\n\nWear an activity monitor to measure daily physical activity. Complete a baseline observation period lasting 7, 14, or 21 days. Take part in a 12-week Nintendo Switch-based exergame physical activity program with guidance, goal setting, self-monitoring, feedback, and caregiver support.\n\nComplete a 2-week observation period after the program to see whether physical activity changes are maintained.\n\nComplete study assessments at screening, the end of baseline, week 4, week 8, week 12, and the end of the observation period.\n\nResearchers will also collect information on step counts, energy expenditure, self-reported physical activity, exercise capacity, quality of life, adherence, acceptability, and adverse events.",[28,174],"Physical Inactivity",[176,177,178,179,180,181,182,183,28,184],"Exergame","Physical Activity","Moderate-to-Vigorous Physical Activity","Children","Adolescents","Single-Case Experimental Design","Multiple-Baseline Design","Nintendo Switch","Accelerometer","2026-05-15",{"date":187,"type":39},"2026-05-18",{"date":69,"type":21},{"date":190,"type":21},"2027-09-01",{"name":192,"class":46},"The Children's Hospital of Zhejiang University School of Medicine",{"id":194,"slug":195,"hasResults":12,"nctId":196,"briefTitle":197,"officialTitle":198,"acronym":199,"eligibilityCriteria":200,"healthyVolunteers":12,"sex":17,"minAge":201,"maxAge":202,"enrollmentInfo":203,"targetDuration":4,"studyType":22,"phases":205,"briefSummary":206,"conditions":207,"keywords":210,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":213,"lastUpdatePostDateStruct":214,"startDateStruct":216,"completionDateStruct":218,"leadSponsor":220,"locationsCount":47},"100601793","effectiveness-of-high-energy-density-enteral-nutrition-for-enhancing-physical-growth-and-cognitive-brain-development-in-infants-with-congenital-heart-disease-100601793","NCT07115108","Effectiveness of High-Energy Density Enteral Nutrition for Enhancing Physical Growth and Cognitive Brain Development in Infants With Congenital Heart Disease","Effectiveness of High-Energy Density Enteral Nutrition for Enhancing Physical Growth and Cognitive Brain Development in Infants With Congenital Heart Disease: A Randomized Controlled Study","RCT","Inclusion Criteria:\n\n* Diagnosed with congenital heart disease through symptoms, physical signs, imaging, and ultrasound examinations.\n* Age 0-6 months\n* Children with nutritional risks (defined by STRONGkids: Nutritional risk screening tool for children )\n* Artificial or mixed feeding\n* Open heart surgery under cardiopulmonary bypass\n* The guardians of the children voluntarily participate in this study and sign a written informed consent form before the surgery.\n\nExclusion Criteria:\n\n* Diagnosed with major non cardiac diseases leading to nutritional intake disorders, such as congenital gastrointestinal malformations, preoperative diagnosis of gastroesophageal reflux, genetic diseases related to growth restriction, and various syndromes with chromosomal abnormalities (trisomy 21 syndrome, trisomy 18 syndrome)\n* Abnormal immune system function due to congenital or acquired factors, unable to effectively resist pathogens or eliminate abnormal cells, which can be divided into primary and secondary immunodeficiencies.\n* Any pre - operative history of neurological diseases (e.g., encephalitis, epilepsy).\n* Secondary or primary gastrointestinal infection symptoms such as abdominal distension and diarrhea after surgery.\n* Estimated stay time in the postoperative intensive care unit ≤ 2 days","0 Months","6 Months",{"count":204,"type":21},160,[24],"The purpose of this study is to compare the effect of high and ordinary energy density enteral nutrition for improving physical growth and brain cognitive development in infants with congenital heart disease after operation, as well as evaluate the safety of interventions.",[28,208,209],"Enteral Nutrition","Pediatrics",[211,212,209],"Congenital heart disease","Enteral nutrition","2026-05-12",{"date":215,"type":39},"2026-05-13",{"date":217,"type":39},"2025-10-13",{"date":219,"type":21},"2026-12-31",{"name":221,"class":46},"Children's Hospital of Fudan University",{"id":223,"slug":224,"hasResults":12,"nctId":225,"briefTitle":226,"officialTitle":227,"acronym":228,"eligibilityCriteria":229,"healthyVolunteers":12,"sex":17,"minAge":230,"maxAge":231,"enrollmentInfo":232,"targetDuration":4,"studyType":59,"phases":4,"briefSummary":234,"conditions":235,"keywords":237,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":213,"lastUpdatePostDateStruct":239,"startDateStruct":240,"completionDateStruct":242,"leadSponsor":244,"locationsCount":47},"100566693","pda-for-kidneys-study-100566693","NCT06658496","PDA for Kidneys Study","Development of a Novel Kidney-focused Approach to Treatment of a Patent Ductus Arteriosus (PDA) in Vulnerable Preterm Neonates - A Pilot Study","PDA4K","Inclusion Criteria:\n\n* Delivered at \\\u003C32 weeks' gestation\n* ≤72 hours of age\n* Inpatient at Meriter Hospital, Inc. NICU\n* At least one parent\u002Fguardian is able to provide parental permission in English or Spanish\n\nExclusion Criteria:\n\n* Major congenital anomalies of kidney\n* Attending physician's discretion to not place NIRS sensors due to clinical concerns\n* In the PI or Co-I's medical opinion, there is a significant likelihood that the neonate would not survive the first 3 days of life\n* Birth parent aged \\\u003C18","1 Minute","7 Days",{"count":233,"type":21},45,"The goal of this observational study is to gather more information on kidney oxygen levels in babies with a patent ductus arteriosus (PDA), and evaluate the relationships between kidney oxygen levels, PDA status and kidney injury.\n\nResearchers will do this by looking at ultrasound images of the heart, analyzing substances in the urine, and evaluating oxygen levels in the kidneys.",[236,28],"Patent Ductus Arteriosus",[238],"neonate",{"date":185,"type":39},{"date":241,"type":39},"2024-12-19",{"date":243,"type":21},"2027-05",{"name":245,"class":46},"University of Wisconsin, Madison",{"id":247,"slug":248,"hasResults":12,"nctId":249,"briefTitle":250,"officialTitle":251,"acronym":252,"eligibilityCriteria":253,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":254,"enrollmentInfo":255,"targetDuration":4,"studyType":59,"phases":4,"briefSummary":257,"conditions":258,"keywords":262,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":268,"lastUpdatePostDateStruct":269,"startDateStruct":270,"completionDateStruct":272,"leadSponsor":274,"locationsCount":277},"100570778","prenatal-maternal-mental-health-and-neurodevelopment-in-congenital-heart-disease-100570778","NCT06711666","Prenatal Maternal Mental Health and Neurodevelopment in Congenital Heart Disease","Prenatal Maternal Mental Health and Neurodevelopment in Children With an Antenatal Diagnosis of Congenital Heart Disease: The Neuro-Moms CHD Study","Neuro-Moms","Inclusion Criteria for the mother of a child diagnosed with CHD:\n\n1. Age at least 18 years old\n2. Expecting women\n3. Having received a diagnosis of foetal critical cyanotic CHD (i.e., CHD physiology that can compromise blood oxygenation after birth). This type of CHDs corresponds to the highest level of neurological risk as reported by the American Heart Association guidelines(1).\n4. Pregnancy of at least 28 weeks of gestation (third trimester) and up to the 38 weeks of gestation at the time of enrolment and prenatal visit for the study.\n5. Medical maternal and paediatric cardiology follow-up in one of the investigating hospitals (Montpellier, Necker Children's Hospital in Paris and Bordeaux).\n6. A delay of a minimum of 4 weeks between the initial diagnosis of foetal congenital heart disease.\n7. Social security affiliation in France.\n\nInclusion criteria for the father or co-parent:\n\n1. Co-parent of an expecting woman participating in the study\n2. Age at least 18 years old\n3. Social security affiliation in France.\n\nInclusion criteria for the child diagnosed with congenital heart disease:\n\n1. Child with a prenatal diagnosis of isolated complex congenital heart disease, born to a mother already participating in the study\n2. Written consent from both parents\n3. Social security affiliation in France.\n\nNon-inclusion Criteria for mothers:\n\n1. Patient refusal to participate\n2. Participants (i.e., expecting women) who express a wish for medical termination of pregnancy\n3. Diagnosis of a complex CHD associated with another foetal comorbidity with a clinically recognized impact on neurodevelopment (e.g., genetic syndromes such as trisomies, poly-malformation syndromes).\n4. Participants who are not able to understand the instructions and\u002For complete the self-reports\n5. Expecting women who currently have a major psychiatric condition (e.g., untreated major depression, severe anxiety disorders, psychotic disorders) with or without treatment, at the time of the cardiology consultation or at the time of the first psychological evaluation. Patients who will be excluded due to these conditions will be referred for perinatal psychiatric consultation.\n6. Persons under legal or judicial guardianship.\n\nNon-inclusion Criteria for fathers or co-parents:\n\n1. Patient refusal to participate\n2. Participants with a severe psychiatric disorder (severe depression, psychotic disorders) with or without treatment\n3. Persons under legal or judicial guardianship.\n\nExclusion Criteria for the mother of a child diagnosed with CHD:\n\n1\\. The child has not undergone surgery within 60 days of birth.\n\nExclusion Criteria for children with CHD:\n\n1\\. Genetic anomalies, brain malformations that may render difficult the neurodevelopmental assessment.","50 Years",{"count":256,"type":21},174,"Congenital heart disease (CHD) is the leading cause of congenital malformations, representing 1% of live births. Progress in surgical care have led to the dramatic increase in the population of children and adults living with heart disease. As survival is no longer a concern, long-term outcomes have become the major public health issue. Prenatal diagnosis of CHD requiring open-heart surgery can be a traumatic event for expecting mothers and fathers. In the general population, maternal mental health distress is associated with fetal disturbances in the hypothalamic-adrenal-pituitary system axis, restricted intrauterine growth and adverse outcomes in the offspring. It is unknown whether prenatal maternal psychological distress have an impact on neurodevelopmental outcomes in CHD. Our national study seeks to (1) characterize the impact of prenatal maternal psychological distress on neurodevelopmental outcomes at age 1 for children with CHD who undergo neonatal open-heart surgery; (2) investigate the sociodemographic and medical determinants associated with prenatal maternal mental health of women carrying a foetus diagnosed with complex CHD; (3) explore the mediating role of prenatal risk factors (i.e., sociodemographic, medical and maternal coping mechanisms) in the association of prenatal maternal mental health (i.e., distress, anxiety and depression) and neurodevelopment in children with CHD; and (4) explore the impact of paternal or the co-parent's mental health impact on neurodevelopmental outcomes at age 1 in children with CHD. This study is a non-interventional, prospective, and longitudinal study of prenatal maternal mental health and subsequent child's neurodevelopmental and behavioural outcomes. It includes a follow-up period from the 3rd trimester of pregnancy until the child's first year of life. It will include children with a prenatally diagnosed heart defect requiring open-heart surgery within the first weeks of life. Understanding and preventing the neurodevelopmental sequelae of heart disease diagnosed in-utero is a public health priority.",[28,259,260,261],"Cyanotic Congenital Heart Disease","d-Transposition of the Great Arteries","Hypoplastic Left Heart Syndrome",[263,264,265,266,267],"psychological stress","Maternal prenatal mental health","Neurodevelopment","Cyanotic congenital heart disease","Prenatal diagnosis","2026-05-11",{"date":213,"type":39},{"date":271,"type":39},"2025-06-27",{"date":273,"type":21},"2028-01",{"name":275,"class":276},"Institut National de la Santé Et de la Recherche Médicale, France","OTHER_GOV",5,{"id":279,"slug":280,"hasResults":12,"nctId":281,"briefTitle":282,"officialTitle":283,"acronym":4,"eligibilityCriteria":284,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":285,"enrollmentInfo":286,"targetDuration":4,"studyType":59,"phases":4,"briefSummary":288,"conditions":289,"keywords":290,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":293,"lastUpdatePostDateStruct":294,"startDateStruct":295,"completionDateStruct":297,"leadSponsor":299,"locationsCount":47},"100455671","fontan-associated-liver-disease-and-the-evaluation-of-biomarkers-for-disease-severity-assessment-100455671","NCT05213598","Fontan Associated Liver Disease and the Evaluation of Biomarkers for Disease Severity Assessment","Natural History of Fontan Associated Liver Disease and the Evaluation of Biomarkers for Disease Severity Assessment","* INCLUSION CRITERIA:\n\nIn order to be eligible to participate in this study, an individual must meet all of the following criteria:\n\n1. Male and female subjects \\>= 18 years of age.\n2. Past surgical history of Fontan procedure.\n3. Prior enrollment in the Liver Diseases Branch protocol 91DK0214\n4. Underwent cardiac catheterization or transjugular liver biopsy within ten years prior to the date of screening\n5. Approved to proceed by the NIH Cardiology Consult\n6. Approved to proceed by the NIH Cardiac Pre-anesthesia Consult\n\nEXCLUSION CRITERIA:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n1. Evidence of other forms of liver disease that typically result in cirrhosis.\n2. Evidence of active Chronic Hepatitis B infection as defined by the presence of hepatitis B surface antigen (HBsAg) in serum and elevated HBV DNA (\\>10,000 IU\u002FmL).\n3. Hepatitis C as defined by the presence of hepatitis C RNA in serum.\n4. Evidence of other liver disease such as primary sclerosing cholangitis, primary biliary cirrhosis, Wilson s disease, autoimmune hepatitis as defined by either liver histology or laboratory abnormalities.\n5. Hemochromatosis as defined by presence of 3+ or 4+ stainable iron on liver biopsy or homozygosity for C282Y. Patients with iron saturation indices of \\>45% and serum ferritin levels of \\>300 ng\u002Fml for men and \\>250 ng\u002Fml for women will undergo genetic testing for hemochromatosis.\n6. Bile duct obstruction as suggested by imaging studies done within the previous six months.\n7. Active substance abuse, such as alcohol, inhaled or injection drugs within the previous one year (assessed during patient interviews or by patient self-report).\n8. Evidence of hepatocellular carcinoma; either alpha-fetoprotein (AFP) levels greater than 50 ng\u002Fml (normal \\\u003C6.6 ng\u002Fml) and\u002For ultrasound (or other imaging study) demonstrating a mass suggestive of liver cancer.\n9. Evidence of Cholangiocarcinoma.\n10. A documented or otherwise stated severe allergic reaction to contrast.\n11. Any other severe condition, which in the opinion of the investigators would impede the patient s participation or compliance in the study.\n12. Radiation exposure exceeds 5 rems during the past year.\n13. Inability to comply or give written informed consent as there is no direct benefit from participation in this study.\n14. Female subjects who are currently pregnant will be excluded due to radiation exposure necessary for study completion. In addition, altered hemodynamics may confound the study s results. Following pregnancy, patients may be reconsidered for the study.","100 Years",{"count":287,"type":21},100,"Background:\n\nIn Fontan Associated Liver Disease (FALD), congestion of blood in the liver causes cirrhosis. This condition can cause death. Researchers want to understand what triggers this process and find new treatments for it.\n\nObjective:\n\nTo understand how long-term congestion of blood in the liver causes liver scarring that eventually leads to cirrhosis.\n\nEligibility:\n\nPeople aged 18 and older who are at risk of developing FALD from the Fontan procedure.\n\nDesign:\n\nParticipants will be screened with:\n\nMedical history\n\nPhysical exam\n\nBlood and urine tests\n\nLiver ultrasound. This uses sound waves to take pictures of the body.\n\nParticipants will have an outpatient visit within 12 weeks after screening. Within 24 weeks later, they will have a 3-day hospital stay. About 2 weeks later, they will have a follow-up visit.\n\nVisits will include repeats of the screening tests and:\n\nHeart tests\n\nStool collection\n\nQuestionnaires\n\nMRI of the liver. Participants will lie on a bed that slides in and out of the scanner. They will receive a contrast agent injected into a vein. While in the scanner, they will also have an MRCP to view the bile ducts and the pancreatic duct.\n\nFibroscan exam. This is an ultrasound that uses a special probe to look at the toughness of the liver.\n\nUpper endoscopy. This uses a thin scope to look inside the upper digestive tract.\n\nLiver biopsy. This will be taken through large vein in the neck or through the chest. Just before the biopsy, participants will have pressure measurements inside their liver. For this, a catheter will be inserted into a neck vein and guided into the liver.",[28],[291,292],"Cardiac Hepatopathy","Natural History","2026-05-09",{"date":213,"type":39},{"date":296,"type":39},"2022-09-07",{"date":298,"type":21},"2051-06-30",{"name":300,"class":301},"National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)","NIH",{"id":303,"slug":304,"hasResults":12,"nctId":305,"briefTitle":306,"officialTitle":307,"acronym":4,"eligibilityCriteria":308,"healthyVolunteers":12,"sex":17,"minAge":309,"maxAge":310,"enrollmentInfo":311,"targetDuration":4,"studyType":22,"phases":313,"briefSummary":314,"conditions":315,"keywords":319,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":322,"lastUpdatePostDateStruct":323,"startDateStruct":324,"completionDateStruct":326,"leadSponsor":328,"locationsCount":133},"100639102","empowering-families-in-pediatric-cardiovascular-surgery-a-ram-based-approach-100639102","NCT07575451","Empowering Families in Pediatric Cardiovascular Surgery: A RAM-Based Approach","Evaluation of a Nursing Program Based on Roy's Adaptation Model for Empowering Families of Children Aged 1 to 3 Years Post-Cardiac Surgery","Inclusion Criteria:\n\n* Families who agree to participate in the study and sign the informed consent form.\n* Families of children aged 1-3 years in the preoperative period who are scheduled to undergo cardiac surgery due to congenital heart disease.\n* Families who do not speak or read Turkish but will undergo cardiac surgery due to congenital heart disease will also be included in the study with the assistance of an interpreter.\n* Families who are over 18 years of age and have access to a mobile phone or internet at home.\n\nExclusion Criteria:\n\n* Exclusion criteria include the presence of additional congenital malformations, dysmorphic syndromes, chromosomal or endocrine disorders, severe infection, hypothyroidism, or any similar conditions that could lead to growth and developmental delay in the child, alongside congenital heart disease","1 Year","3 Years",{"count":312,"type":21},80,[24],"The purpose of this clinical trial is to learn about the effects of a nursing support program designed for families of children aged 1 to 3 years who have undergone heart surgery. This program aims to improve parents' caregiving skills and support the healthy growth of their children.\n\nThe primary questions the study aims to answer are:\n\nDoes the nursing program positively affect the physical growth of children, such as their height and weight?\n\nDoes the program improve children's scores on general development tests (Denver II)?\n\nDo parents' attitudes toward child feeding and their confidence in parenting skills increase?\n\nResearchers will divide participants into two groups:\n\nExperimental Group: Families who participate in the nursing education program and receive an informative booklet.\n\nControl Group: Families who only receive an informative booklet and continue with routine hospital follow-ups.\n\nThe researchers will compare these two groups to see if participating in the nursing program leads to better results for the children's development and the families' skills.\n\nParticipants will be asked to:\n\nAttend 5 different education and counseling sessions, starting one week before surgery and continuing until the child reaches 1 year of follow-up.\n\nMeet with the researcher at specific intervals (at 1, 2, 3, 6, 9, and 12 months) for one year to monitor the child's development (height, weight, head circumference) and skills.\n\nComplete surveys regarding child feeding attitudes and parenting skills at the 6th and 12th month follow-ups.",[28,316,317,318],"Postoperative Care","Child Development","Roy Adaptation Model-based Nursing Empowerment Program",[28,320,316,321],"Cardiac Surgery","Nursing Support Program","2026-05-08",{"date":213,"type":39},{"date":325,"type":21},"2026-06-15",{"date":327,"type":21},"2027-06-15",{"name":329,"class":46},"Cukurova University",{"id":331,"slug":332,"hasResults":12,"nctId":333,"briefTitle":334,"officialTitle":335,"acronym":4,"eligibilityCriteria":336,"healthyVolunteers":12,"sex":17,"minAge":337,"maxAge":338,"enrollmentInfo":339,"targetDuration":4,"studyType":59,"phases":4,"briefSummary":341,"conditions":342,"keywords":343,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":348,"lastUpdatePostDateStruct":349,"startDateStruct":350,"completionDateStruct":352,"leadSponsor":354,"locationsCount":47},"100492065","application-of-a-clinical-decision-support-system-to-reduce-mechanical-ventilation-duration-after-cardiac-surgery-in-children-100492065","NCT05687292","Application of a Clinical Decision Support System to Reduce Mechanical Ventilation Duration After Cardiac Surgery in Children","Application of a Clinical Decision Support System to Reduce Mechanical Ventilation Duration After Cardiac Surgery","Inclusion Criteria:\n\n* Children \\\u003C 12 years old\n* Post-cardiac surgery\n* Receiving mechanical ventilation for ≥ 48 hours in the Cardiac Intensive Care Unit at Boston Children's Hospital following surgery\n\nExclusion Criteria:\n\n* Premature infants (\\\u003C37 weeks' gestation)\n* Weight \\\u003C 2kg\n* Baseline ventilator (via tracheostomy) or noninvasive positive pressure dependence","1 Day","12 Years",{"count":340,"type":21},330,"The goal of this study is to evaluate the impact of a clinical decision support system (CDSS) in children receiving mechanical ventilation (MV) after surgery for congenital heart disease (CHD). The main question it aims to answer is:\n\n-What is the impact of a CDSS designed to facilitate weaning and discontinuation of MV on the duration of MV in post-operative congenital cardiac surgery patients?\n\nParticipants will be identified as eligible to initiate weaning from mechanical ventilation. Providers will decide whether or not to initiate weaning based on recommendations provided by the CDSS. Researchers will compare patients exposed to the CDSS with a historical cohort to see if the CDSS facilitated a decrease in MV duration.",[28],[344,95,345,346,347],"cardiac surgery","critical care","pediatrics","mechanical ventilation","2026-05-07",{"date":213,"type":39},{"date":351,"type":39},"2024-11-18",{"date":353,"type":21},"2027-03-01",{"name":355,"class":46},"Boston Children's Hospital",{"id":357,"slug":358,"hasResults":12,"nctId":359,"briefTitle":360,"officialTitle":361,"acronym":362,"eligibilityCriteria":363,"healthyVolunteers":114,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":364,"targetDuration":84,"studyType":59,"phases":4,"briefSummary":366,"conditions":367,"keywords":376,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":378,"lastUpdatePostDateStruct":379,"startDateStruct":380,"completionDateStruct":382,"leadSponsor":384,"locationsCount":47},"100489526","development-of-circ-technologies-100489526","NCT05654272","Development of CIRC Technologies","Development of Cardiovascular Innovation Research Technologies","CIRC","Inclusion Criteria:\n\n* Age ≥ 18 years of age\n* Provision of written informed consent\n* If not healthy volunteer, must be diagnosed with cardiovascular disease\n\nExclusion Criteria:\n\n* Vulnerable populations will be excluded from this study including Prisoners\n* Other contraindications to CMR imaging to be determined by standard MRI protocols\n* Decisionally impaired (e.g., dementia or cognitive disability)",{"count":365,"type":21},1000,"Cardiovascular disease is the leading cause of death worldwide. Advanced cardiovascular imaging using Magnetic Resonance Imaging (MRI) has proven to be effective in providing gold standard myocardial tissue characterization. Moreover, the intrinsic advantage of MRI's lack of exposure to ionizing radiation is particularly beneficial. At the same time, blood work can be very useful in early detection of certain cardiomyopathy, such as amyloid. However, there is a lack of agreement of on which markers are the most sensitive. This multi-study will allow us the unique opportunity to form a more comprehensive understanding for various cardiovascular diseases.\n\nOur team has developed novel cardiac MRI techniques that leverages endogenous tissue properties to reveal a milieu of deep tissue phenotypes including myocardial inflammation, fibrosis, metabolism, and microstructural defects. Among these phenotypes, myocardial microstructure has proven to be most sensitive to early myocardial tissue damage and is predictive of myocardial regeneration. In this study, the investigators aim to further study the importance of cardiac microstructure revealed by MRI in patient and healthy population and compare this novel technology with conventional clinical biomarkers.",[368,62,369,370,371,372,28,373,374,375],"Cardiovascular Diseases","Ischemic Heart Disease","Non-ischemic Cardiomyopathy","Valvular Heart Disease","Metabolic Cardiomyopathy","Aortic Diseases","Atrial Fibrillation","Ventricular Fibrillation",[377],"MRI","2026-05-06",{"date":322,"type":39},{"date":381,"type":39},"2022-09-09",{"date":383,"type":21},"2042-09-09",{"name":385,"class":46},"The Cleveland Clinic",{"id":387,"slug":388,"hasResults":12,"nctId":389,"briefTitle":390,"officialTitle":390,"acronym":4,"eligibilityCriteria":391,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":84,"enrollmentInfo":392,"targetDuration":4,"studyType":59,"phases":4,"briefSummary":394,"conditions":395,"keywords":4,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":397,"lastUpdatePostDateStruct":398,"startDateStruct":399,"completionDateStruct":401,"leadSponsor":403,"locationsCount":47},"100075986","molecular-and-cellular-characterization-of-cardiac-tissue-in-postnatal-development-100075986","NCT00243776","Molecular and Cellular Characterization of Cardiac Tissue in Postnatal Development","Inclusion Criteria:\n\n* Patients undergoing cardiopulmonary bypass surgery\n* Patients undergoing surgery for repair of congenital heart disease such as ventricular septal defect or defective mitral or aortic valves.\n\nExclusion Criteria:\n\n* Prior cardiac surgery\n* History of atrial fibrillation or other atrial arrhythmias prior to operation\n* History of heart failure",{"count":393,"type":21},600,"The study team will use small pieces of human hearts which are removed as part of a required surgical procedure to study different objectives. One of the objective is how calcium ions pass through the membrane of heart cells in order to tell the heart cell how much force to contract with when the heart beats. Investigators will also study the proteins and RNA of these pieces to determine how the newborn heart cells control their force of contraction differently from adult heart cells. Investigators hypothesize that infant hearts have different regulation of calcium entry than adult hearts. The study team also wants to study combinations of 3D cardiac spheres with multiple environmental cues that can improve functional and metabolic maturation of Human pluripotent stem cell-derived cardiomyocytes (hPSC-CMs) and generate a more clinically relevant cell model.",[28,396],"Tetralogy of Fallot","2026-05-04",{"date":378,"type":39},{"date":400,"type":4},"2005-04",{"date":402,"type":21},"2027-12",{"name":404,"class":46},"Emory University",{"id":406,"slug":407,"hasResults":12,"nctId":408,"briefTitle":409,"officialTitle":409,"acronym":4,"eligibilityCriteria":410,"healthyVolunteers":12,"sex":17,"minAge":338,"maxAge":411,"enrollmentInfo":412,"targetDuration":4,"studyType":22,"phases":414,"briefSummary":415,"conditions":416,"keywords":417,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":423,"lastUpdatePostDateStruct":424,"startDateStruct":426,"completionDateStruct":428,"leadSponsor":430,"locationsCount":47},"100635943","implementation-of-an-accessible-healthcare-model-achd-strong-comparing-nurse-and-physician-lead-healthcare-transition-education-in-a-re-aim-framework-100635943","NCT07559253","Implementation of an Accessible Healthcare Model (ACHD STRONG): Comparing Nurse and Physician Lead Healthcare Transition Education in a RE-AIM Framework","Inclusion Criteria (Patient Participants):\n\n* Diagnosed CHD patients between the ages of 12-26 will be eligible\n* Able to provide assent when seen by a pediatric or adult congenital cardiologist provider.\n* A subset of patients will self-identify as having a disability, and or, be identified with disabilities in their medical or educational records.\n* Participants to provide assent\u002Fconsent and complete all study activities in English or Spanish\n* Participants under the age of 18 must have a legal guardian who is able to provide consent in English or Spanish.\n\nExclusion Criteria:\n\n* Providers may decline participation of any patient at their clinical discretion","26 Years",{"count":413,"type":21},450,[24],"The study includes patients with congenital heart disease (CHD), as well as their support persons and their providers, who are preparing to make the transition from pediatric to adult care for their CHD. The purpose of this study is to improve the tools available to help find doctors as patients enter adulthood. 200 people with CHD and support people will be enrolled.",[28],[418,419,420,421,422],"healthcare","transition to adult care","improve care","pediatric","RE-AIM","2026-04-29",{"date":425,"type":39},"2026-05-05",{"date":427,"type":39},"2025-12-01",{"date":429,"type":21},"2026-11-30",{"name":245,"class":46},{"id":432,"slug":433,"hasResults":12,"nctId":434,"briefTitle":435,"officialTitle":435,"acronym":4,"eligibilityCriteria":436,"healthyVolunteers":12,"sex":17,"minAge":230,"maxAge":202,"enrollmentInfo":437,"targetDuration":4,"studyType":22,"phases":439,"briefSummary":440,"conditions":441,"keywords":443,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":423,"lastUpdatePostDateStruct":447,"startDateStruct":449,"completionDateStruct":451,"leadSponsor":453,"locationsCount":456},"100601763","starlight-cardiovascular-lifeline-ductus-arteriosus-stent-ide-study-100601763","NCT07114718","Starlight Cardiovascular Lifeline Ductus Arteriosus Stent IDE Study","Inclusion Criteria:\n\n1. Parental or legal authorized representative provide consent for study enrollment\n2. Infants \\\u003C 6 months of age\n3. Diagnosis of congenital heart defect with ductal-dependent pulmonary circulation requiring infusion of prostaglandins\n4. Requires ductus arteriosus stent diameters of 3.5mm or 4mm and stent lengths between 16mm and 28mm\n\nExclusion Criteria:\n\n1. Active blood stream infection\n2. Active or history of endocarditis\n3. Body weight \\\u003C2.5kg\n4. Gestational age \\\u003C32 weeks at birth\n5. Complete heart block\n6. Total Anomalous Pulmonary Venous Return\n7. Anatomic variation judged to be inappropriate for ductal stenting per the treating interventionalist\n8. Presence of an aortopulmonary collateral that is expected to require unifocalization\n9. Non-confluent pulmonary arteries (i.e. isolated pulmonary artery of ductal origin) or bilateral patent ductus arteriosus (PDA)\n10. Pulmonary atresia with intact ventricular septum with RV-dependent coronary circulation\n11. Currently participating in an investigational drug study or another device study that would confound the study results\n12. Patient who is on extracorporeal membrane oxygenation (ECMO), ventricular assist device (VAD), or dialysis prior to ductal stenting procedure\n13. Major co-morbidities which, in the opinion of the investigator, would negatively alter expected 1-year survival (e.g., intracranial hemorrhage, renal failure, etc.)\n14. Patient who is undergoing another transcatheter procedure (e.g., atrial septostomy, aortic arch intervention, or right ventricular outflow tract intervention) during or within 24 hours prior to the ductus arteriosus stenting procedure\n15. Patient who, at the time of enrollment, is deemed not to be a candidate for eventual stage II palliation of single ventricle heart disease, complete surgical repair, nor transcatheter treatment with resultant biventricular circulation\n16. Patient who does not plan to return to the enrolling center or another participating center for stage II palliation, complete surgical repair, or definitive catheterization procedure\n17. Contraindications to peri-procedural anticoagulation\n18. Known to be non-responsive to aspirin or other antiplatelet therapies\n19. Known hypersensitivity or allergy to Nickel\n20. Known hypersensitivity to contrast media that cannot be adequately pre-medicated",{"count":438,"type":21},35,[24],"Starlight Cardiovascular, Inc. is sponsoring a prospective, multi-center, study to evaluate safety and effectiveness of the Lifeline Ductus Arteriosus Stent System. The study device is a stent that is designed to maintain patency of the Ductus Arteriosus for children who need blood flow through that part of the heart.",[28,442],"Congenital Heart Disease (CHD)",[444,445,446],"Ductus Arteriosus Stent","pediatric stent","Lifeline Stent",{"date":448,"type":39},"2026-05-01",{"date":450,"type":39},"2026-01-16",{"date":452,"type":21},"2028-04",{"name":454,"class":455},"Starlight Cardiovascular Inc","INDUSTRY",8,{"id":458,"slug":459,"hasResults":12,"nctId":460,"briefTitle":461,"officialTitle":462,"acronym":4,"eligibilityCriteria":463,"healthyVolunteers":114,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":464,"targetDuration":4,"studyType":59,"phases":4,"briefSummary":466,"conditions":467,"keywords":4,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":423,"lastUpdatePostDateStruct":469,"startDateStruct":470,"completionDateStruct":472,"leadSponsor":473,"locationsCount":47},"100504491","a-study-of-invasive-hemodynamic-for-machd-registry-100504491","NCT05849025","A Study of Invasive Hemodynamic for MACHD Registry","Invasive Hemodynamic Control Cohort for The Mayo Clinic Adult Congenital Heart Disease (MACHD) Registry","Inclusion Criteria:\n\n* Capacity to Consent\n* BMI \\\u003C\u002F= 30\n* Systolic BP \\\u003C\u002F= 140mmHg\n* Diastolic BP \\\u003C\u002F= 90\n* eGFR \\> 30 (within prior 3 months) to confirm kidney function\n* Able to undergo an MRI\n\nExclusion Criteria:\n\n* History of Cardiovascular disease that may affect the results of the testing performed.\n* Any Current orthopedic limitations\n* Currently taking any cardiac medication\n* Pregnancy",{"count":465,"type":21},50,"This research study is being done to provide comparative data to the Mayo Clinic Adult Congenital Heart Disease Registry.",[468,28],"Healthy",{"date":425,"type":39},{"date":471,"type":39},"2023-10-16",{"date":43,"type":21},{"name":474,"class":46},"Mayo Clinic",{"id":476,"slug":477,"hasResults":12,"nctId":478,"briefTitle":479,"officialTitle":480,"acronym":481,"eligibilityCriteria":482,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":483,"targetDuration":84,"studyType":59,"phases":4,"briefSummary":485,"conditions":486,"keywords":488,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":492,"lastUpdatePostDateStruct":493,"startDateStruct":494,"completionDateStruct":496,"leadSponsor":498,"locationsCount":500},"100228988","swiss-national-registry-of-adults-with-congenital-heart-disease-100228988","NCT02258724","Swiss National Registry of Adults With Congenital Heart Disease","Nationales Register Zur Erfassung Von Erwachsenen Mit Angeborenen Herzfehlern","SACHER","Inclusion Criteria:\n\nAdult (above 18 years of age) with congenital heart disease, treated in one of the Swiss centre with specialized organisation for GUCH patients.\n\nSigned informed consent. Patients with trisomy 21: the parents or legal guardian will have to give the consent.\n\nExclusion Criteria:\n\nNone",{"count":484,"type":21},5000,"Due to successes in the last decades in pediatric heart surgery and cardiology, 90-95% of the children with congenital heart disease reach adult age.This results in an increasing number of adults or \"grown-ups\" with congenital heart disease (ACHD or GUCH patients) that require special health care organization and training programmes. Long term complications of these GUCH patients and optimum treatment strategies are still poorly known. The aim of this registry is to collect quantitative and qualitative data regarding GUCH patients treated in specialised centres in Switzerland.",[28,487],"Congenital Heart Defect",[489,490,491],"Adult","Registry","Grown-up congenital heart disease","2026-04-28",{"date":397,"type":39},{"date":495,"type":4},"2013-09",{"date":497,"type":21},"2033-12",{"name":499,"class":46},"University Hospital, Basel, Switzerland",6,{"id":502,"slug":503,"hasResults":12,"nctId":504,"briefTitle":505,"officialTitle":506,"acronym":507,"eligibilityCriteria":508,"healthyVolunteers":12,"sex":17,"minAge":509,"maxAge":18,"enrollmentInfo":510,"targetDuration":4,"studyType":22,"phases":511,"briefSummary":514,"conditions":515,"keywords":523,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":528,"lastUpdatePostDateStruct":529,"startDateStruct":531,"completionDateStruct":533,"leadSponsor":534,"locationsCount":47},"100630322","phase-1-influence-of-lung-volume-optimization-maneuver-on-cardiac-output-and-lung-compliance-in-ventilated-children-with-congenital-heart-disease-undergoing-surgical-repair-100630322","NCT07486167","Influence of Lung Volume Optimization Maneuver on Cardiac Output and Lung Compliance in Ventilated Children With Congenital Heart Disease Undergoing Surgical Repair","Influence of Lung Volume Optimization Maneuver on Cardiac Output and Lung Mechanics in Children With Congenital Heart Disease","ILOCO-CHD","Inclusion Criteria:\n\n* Inclusion Criteria\n* congenital heart disease\n* surgery with cardiopulmonary bypass\n\nExclusion Criteria:\n\n* single ventricle physiology\n* ECMO\u002FVAD\n* \\\u003C36weeks of gestational age\n* chronic lung disease\n* Endotracheal tube leak \\> 15%\n* lack of informed consent from parents.","0 Days",{"count":312,"type":21},[512,513],"PHASE1","PHASE2","The aim of this randomized interventional multi-center clinical trial is to determine whether a standardized lung volume optimization maneuver (LVOM), including PEEP titration, improves outcomes in children undergoing biventricular repair for congenital heart disease (CHD) with cardiopulmonary bypass.\n\nThe primary hypothesis is that optimizing end-expiratory lung volume through a standardized PEEP titration maneuver improves cardiac performance and lung function.\n\nSecondary objectives are to evaluate whether this strategy reduces duration of mechanical ventilation, improves hemodynamics and ventilation-perfusion matching, and decreases the need for vasopressor support.",[28,516,517,518,519,520,521,179,522,320],"Cardiopulmonary Bypass","Mechanical Ventilation","Peep Titration in Lung Protective Ventilation","Positive End-expiratory Pressure (PEEP)","Lung Volume","Lung Mechanics","Hemodynamic Changes",[524,525,526,527],"cardiopulmonary interactions","end-expiratory lung volume","electrical impedance tomography","PEEP titration","2026-04-26",{"date":530,"type":39},"2026-04-30",{"date":532,"type":21},"2026-09-01",{"date":105,"type":21},{"name":535,"class":46},"Charite University, Berlin, Germany",{"id":537,"slug":538,"hasResults":12,"nctId":539,"briefTitle":540,"officialTitle":541,"acronym":4,"eligibilityCriteria":542,"healthyVolunteers":12,"sex":17,"minAge":309,"maxAge":543,"enrollmentInfo":544,"targetDuration":4,"studyType":22,"phases":546,"briefSummary":547,"conditions":548,"keywords":553,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":558,"lastUpdatePostDateStruct":559,"startDateStruct":560,"completionDateStruct":562,"leadSponsor":564,"locationsCount":566},"100635438","effects-of-high-calorie-diets-vs-high-calorie-formulas-on-weight-gain-in-children-with-congenital-heart-disease--100635438","NCT07552688","\"Effects of High-Calorie Diets VS High-Calorie Formulas on Weight Gain in Children With Congenital Heart Disease \"","\"Effects of High-Calorie Diet vs High-Calorie Formula on Weight Gain and Clinical Outcomes Among Children With Congenital Heart Disease\"","Inclusion Criteria:\n\n* Children aged 1 to 5 years.\n* Diagnosed with congenital heart disease (confirmed by echocardiography).\n* Underweight (weight-for-age below the 10th percentile).\n* Medically stable and eligible for oral or enteral feeding.\n* Informed consent obtained from a parent.\n\nExclusion Criteria:\n\n* Children with genetic syndromes known to affect growth (e.g., Down syndrome).\n* Children with gastrointestinal conditions impairing nutrient absorption.\n* Children who had cardiac surgery within the last 4 weeks.\n* Presence of severe organ failure (renal, hepatic, etc.).\n* Children on parenteral nutrition.\n* Families unlikely to adhere to follow-up or dietary instructions.","5 Years",{"count":545,"type":21},75,[24],"This study is a randomized controlled trial designed to evaluate the effects of high-calorie diets and specialized nutritional formulas on weight gain and clinical outcomes in underweight children aged 1 to 5 years with congenital heart disease (CHD). Children with CHD often experience growth failure due to increased energy needs and feeding difficulties, which can negatively impact their recovery, development, and overall health.\n\nSeventy-five children will be randomly assigned to one of three groups: a control group receiving a standard diet, a group receiving a high-calorie diet made from energy-dense foods, and a third group receiving both the high-calorie diet and a specialized high-calorie pediatric formula. The study will measure changes in weight, appetite, feeding tolerance, and other growth indicators over an 8-week period. The goal is to determine whether enhanced nutritional support can improve weight gain and health outcomes in this high-risk population.",[549,550,551,28,552],"Weight Gain","Body Mass Index","Pediatric Nutrition","Undernutrition",[554,555,556,557],"BMI","Nutritional Status","Growth and Development","Pediatric Nursing","2026-04-24",{"date":423,"type":39},{"date":561,"type":21},"2026-04-17",{"date":563,"type":21},"2026-06-01",{"name":565,"class":46},"Aryan Najmadin Nasradin",2,{"id":568,"slug":569,"hasResults":12,"nctId":570,"briefTitle":571,"officialTitle":572,"acronym":4,"eligibilityCriteria":573,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":309,"enrollmentInfo":574,"targetDuration":4,"studyType":22,"phases":576,"briefSummary":577,"conditions":578,"keywords":579,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":582,"lastUpdatePostDateStruct":583,"startDateStruct":584,"completionDateStruct":586,"leadSponsor":588,"locationsCount":47},"100506087","hfnc-vs-nippv-following-extubation-100506087","NCT05869825","HFNC vs NIPPV Following Extubation","High Flow Nasal Cannula and Non-Invasive Positive Pressure Ventilation Following Extubation in Infants After Cardiac Surgery for Congenital Heart Disease: A Randomized Clinical Trial","Inclusion Criteria:\n\n* All patients admitted to the CICU following cardiac surgery for CHD who are \\\u003C\u002F= 1 year of age and\u002For weight \\\u003C\u002F= 10 kg\n\nExclusion Criteria:\n\n* Patients who remain intubated for \\>\u002F= 4 weeks\n* Patients who have a tracheostomy prior to their cardiac surgery\n* Patient enrolled in a competing research study\n* Patients requiring extracorporeal membrane oxygenation (ECMO) support preoperatively\n* Patients with birth weight \\\u003C 2 Kg.\n* Gestational age \\\u003C 35 weeks at birth.\n* Patients with extracardiac anomalies more than minor severity.",{"count":575,"type":21},200,[24],"This study has the goal to determine the best method of respiratory support following extubation after cardiac surgery (CS). After cardiac surgery for Congenital Heart Disease (CHD), patients remain intubated until the cardiac team determines it is safe for the patient to undergo a trial of extubation. Two common methods of respiratory support following extubation are High Flow Nasal Cannula (HFNC) and Non Invasive Positive Pressure Ventilation (NIPPV). There is currently a gap in data comparing High Flow Nasal Cannula and Non-Invasive Positive Pressure Ventilation in infants (age 0-1) in regard to extubation failure and overall outcomes.\n\nThis study will monitor the health outcomes of 200 infants (0 - 1 year) with CHD following cardiac surgery in the Cardiac Intensive Care Unit (CICU) at Children's Healthcare of Atlanta (CHOA). This will be done by assigning the respiratory support method each child will receive following extubation after cardiac surgery. Health outcomes will be monitored until discharge or until the second instance of extubation failure.\n\nBoth study arms are standard-of-care respiratory support methods in the CHOA CICU. The investigators aim to determine which of these two methods has fewer risk factors when used with infants.",[28],[580,581],"Cardiac surgery for CHD","Cardiac Intensive Care Unit","2026-04-23",{"date":423,"type":39},{"date":585,"type":39},"2025-02-27",{"date":587,"type":21},"2026-05",{"name":404,"class":46},{"id":590,"slug":591,"hasResults":12,"nctId":592,"briefTitle":593,"officialTitle":594,"acronym":595,"eligibilityCriteria":596,"healthyVolunteers":114,"sex":17,"minAge":115,"maxAge":597,"enrollmentInfo":598,"targetDuration":4,"studyType":59,"phases":4,"briefSummary":600,"conditions":601,"keywords":606,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":611,"lastUpdatePostDateStruct":612,"startDateStruct":613,"completionDateStruct":615,"leadSponsor":617,"locationsCount":47},"100565751","neodoppler-new-ultrasound-technology-for-continuous-monitoring-of-cerebral-circulation-pilot-100565751","NCT06646250","NeoDoppler: New Ultrasound Technology for Continuous Monitoring of Cerebral Circulation Pilot","NeoDoppler: New Ultrasound Technology for Continuous Monitoring of Cerebral Blood Flow in Infants","CE-NeoDoppler","Inclusion Criteria:\n\n* Open fontanelle\n* Healthy preterm or term born neonates\n* Neonates with a medical condition of interest according to the different cohort studies: patent ductus arteriosus, perinatal asphyxia, stroke, pulmonary hypertension, congenital heart condition or infection\u002Fsepsis\u002Fmeningitis\n* Neonates in need of procedures\n\nExclusion Criteria:\n\n* Caregivers not understanding\u002Fspeaking Norwegian or English\n* Caregivers not giving their consent","12 Months",{"count":599,"type":21},180,"Non-invasive tools for monitoring of course of disease are important and necessary in the treatment of pre-term\u002Fpremature infants and sick neonates. For many years, the ultrasound group in Trondheim has been at the forefront in the development of new ultrasound technology for the diagnosis and monitoring of disease. Several methods previously developed in this research group are today widely used in hospitals around the world. In this project the investigators aim to test a new ultrasound technology that allows continuous monitoring of cerebral blood flow in sick neonates and pre-term children. This technology was CE-certified in October 2022, and in this project the investigators will test the CE-certified version with the newest available approved software.",[602,236,603,604,605,90,28],"Preterm","Sepsis","Asphyxia","Stroke",[607,608,609,610],"Cerebral Doppler","Monitoring","Continuous","Neonate","2026-04-22",{"date":582,"type":39},{"date":614,"type":39},"2024-10-20",{"date":616,"type":21},"2029-12-31",{"name":618,"class":46},"St. Olavs Hospital",{"id":620,"slug":621,"hasResults":12,"nctId":622,"briefTitle":623,"officialTitle":624,"acronym":4,"eligibilityCriteria":625,"healthyVolunteers":12,"sex":17,"minAge":310,"maxAge":626,"enrollmentInfo":627,"targetDuration":4,"studyType":22,"phases":629,"briefSummary":630,"conditions":631,"keywords":4,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":632,"lastUpdatePostDateStruct":633,"startDateStruct":634,"completionDateStruct":636,"leadSponsor":637,"locationsCount":47},"100521873","online-support-4-chd-kids--caregivers-100521873","NCT06075251","Online Support 4 CHD Kids & Caregivers","Stepped-Care Online Parent Support Following Congenital Heart Disease: A Randomized Control Trial","Inclusion Criteria:\n\n* Parent of a child aged 3 to 9 years with history of congenital heart disease\n* Parent of a patient at The Hospital for Sick Children (SickKids)\n* Resident of Ontario, Canada\n\nExclusion Criteria:\n\n* Significant major medical issues requiring ongoing inpatient care (e.g., children participating in significant surgical or inpatient treatment)\n* Current participation in an equivalent family\u002Fparent therapy program (e.g., Incredible Years Parenting Program (IYPP), Positive Parenting Program (Triple P))\n* Previous participation in an I-InTERACT-North pilot study","9 Years",{"count":628,"type":21},382,[24],"This study will evaluate a virtual mental health parenting stepped-care intervention (I-InTERACT-North) to determine if the program works to improve positive parenting skills and child behaviour among families with children born with Congenital Heart Disease (CHD). Recruitment will target children ages 3-9 years old from SickKids. We will also evaluate the acceptability and feasibility of the program among children and families to inform future delivery and multi-site trials. Results will evaluate whether I-InTERACT-North can improve parenting and child behaviour in these families and inform future best clinical practices for this population.",[28],"2026-04-21",{"date":558,"type":39},{"date":635,"type":39},"2024-02-15",{"date":105,"type":21},{"name":638,"class":46},"The Hospital for Sick Children",{"id":640,"slug":641,"hasResults":12,"nctId":642,"briefTitle":643,"officialTitle":644,"acronym":4,"eligibilityCriteria":645,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":646,"targetDuration":309,"studyType":59,"phases":4,"briefSummary":648,"conditions":649,"keywords":4,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":655,"lastUpdatePostDateStruct":656,"startDateStruct":658,"completionDateStruct":660,"leadSponsor":662,"locationsCount":47},"100633308","a-chinese-multicenter-study-on-surgical-techniques-and-outcomes-across-the-lifespan-in-congenital-heart-disease-100633308","NCT07524998","A Chinese Multicenter Study on Surgical Techniques and Outcomes Across the Lifespan in Congenital Heart Disease","Evaluation of Surgical Techniques and Outcomes Across the Lifespan in Congenital Heart Disease Based on a Chinese Multicenter Database","Inclusion Criteria:\n\n* Clinical diagnosis of Complex Congenital Heart Disease (CCHD) who underwent surgical intervention and were enrolled in the 13th Five-Year Plan National Congenital Heart Disease Surgery Database\n* Clinical diagnosis of CCHD requiring surgical\u002Fintrauterine intervention or cardiac rehabilitation\n* Willing to sign informed consent and complete follow-up\n\nExclusion Criteria:\n\n* Lost to follow-up\n* \\>30% missing core clinical data\n* Severe extracardiac malformations, systemic dysfunction, or other conditions precluding study participation, per sub-study specific exclusion criteria",{"count":647,"type":21},3000,"The goal of this observational study is to learn about recovery after heart surgery for people with Complex Congenital Heart Disease (CCHD), build a comprehensive data platform for CCHD care across a person's whole life, and create a China-specific quality control system to improve CCHD surgical care.\n\nThe main questions it aims to answer are:\n\nWhat are the main risk factors that affect how well people with CCHD recover after heart surgery? Can a whole life course, multi-dimensional data platform for CCHD care be built to support better clinical quality control? Can a China-specific system to evaluate and control the quality of CCHD heart surgery be developed to guide national health policies and improve patient outcomes?\n\nParticipants in this study are people with CCHD who have had or will have heart surgery at participating medical centers. This includes two groups:\n\nA retrospective group: People who already had CCHD heart surgery and were included in the existing National Congenital Heart Disease Surgery Database.\n\nA prospective group: People who are scheduled to have CCHD heart surgery as part of related sub-studies of this project.\n\nPeople who are lost to follow-up or have more than 30% missing data will not be included.\n\nParticipants will:\n\nFor the retrospective group: Have their past medical records (from surgery and follow-up) analyzed by researchers to find risk factors linked to recovery after CCHD heart surgery.\n\nFor the prospective group: Have their pre-surgery tests, surgery details, care during and after surgery, and follow-up data (including up to 1 year after surgery) collected as part of their regular medical care.\n\nResearchers will combine data from both groups into a new registry, work with a third-party committee to check data quality, and use this combined data to build a quality control and evaluation system for CCHD heart surgery. This system will help show the current state of CCHD care in China and guide national health decisions.",[28,650,651,652,653,654],"Complex Congenital Heart Disease","Surgery (Cardiac)","Perioperative Care","Quality Control","Health Care","2026-04-10",{"date":657,"type":39},"2026-04-13",{"date":659,"type":39},"2025-02-01",{"date":661,"type":21},"2029-01-31",{"name":663,"class":276},"China National Center for Cardiovascular Diseases",{"id":665,"slug":666,"hasResults":12,"nctId":667,"briefTitle":668,"officialTitle":669,"acronym":670,"eligibilityCriteria":671,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":672,"targetDuration":4,"studyType":22,"phases":674,"briefSummary":675,"conditions":676,"keywords":682,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":692,"lastUpdatePostDateStruct":693,"startDateStruct":694,"completionDateStruct":695,"leadSponsor":696,"locationsCount":47},"100633038","llm-based-intelligent-health-management-assistant-in-life-cycle-health-management-of-cardiac-surgery-patients-100633038","NCT07521488","LLM-Based Intelligent Health Management Assistant in Life-Cycle Health Management of Cardiac Surgery Patients","Application of Large Language Model-Based Intelligent Health Management Assistant in Life-Cycle Health Management of Patients After Cardiac Surgery: A Prospective Randomized Controlled Study","cFT-LLM","Inclusion Criteria:\n\n1. Aged 18 years or older, any sex\n2. Underwent cardiac surgery at the Department of Cardiac Surgery, Beijing Anzhen Hospital, Capital Medical University, including but not limited to: coronary artery bypass grafting (CABG), heart valve replacement or repair (aortic valve, mitral valve, or tricuspid valve surgery), great vessel surgery (aortic dissection or aortic aneurysm repair), congenital heart disease correction, or cardiac assist device implantation\n3. Clinically stable after surgery and eligible for hospital discharge\n4. Has access to a smartphone and is capable of independently operating a mobile application, or has a family member available to assist with operation\n5. Voluntarily participates in the study, understands and signs the informed consent form, and is able to comply with the study protocol requirements\n\nExclusion Criteria:\n\n1. Postoperative intensive care unit (ICU) stay exceeding 30 days, or presence of severe uncontrolled postoperative complications such as persistent infection or multi-organ failure\n2. Life expectancy less than 12 months due to advanced malignancy or end-stage organ failure\n3. Severe cognitive impairment, psychiatric disorder, or inability to understand and use a mobile application without available caregiver assistance\n4. Heart transplant recipient\n5. Currently participating in another interventional clinical study\n6. Anticipated inability to complete 12-month follow-up",{"count":673,"type":21},500,[24],"This is a single-center, prospective, randomized, open-label, parallel-controlled clinical study to evaluate the effectiveness of a large language model (LLM)-based intelligent health management assistant in the life-cycle health management of patients after cardiac surgery. A total of 500 adult patients who undergo cardiac surgery (including coronary artery bypass grafting, heart valve surgery, great vessel surgery, congenital heart disease correction, and other cardiac procedures) at Beijing Anzhen Hospital will be randomly assigned in a 1:1 ratio to an intervention group or a control group, stratified by age (\\\u003C65 vs ≥65 years) and surgery type. The intervention group will use the LLM-based mobile health management application in addition to standard postoperative care, while the control group will receive standard postoperative care alone. The application integrates multimodal clinical data into a personalized health profile and provides surgery-type-specific postoperative management recommendations, medication adherence reminders, complication early warning, and cardiac rehabilitation guidance. The primary outcome is the composite endpoint of major adverse cardiac and cerebrovascular events (MACCE), defined as all-cause death, non-fatal myocardial infarction, non-fatal stroke, or unplanned cardiovascular reoperation\u002Freintervention, within 12 months after randomization. Secondary outcomes include health-related quality of life (EQ-5D-5L), cardiovascular rehospitalization rate, medication adherence (MMAS-8), postoperative complication rate, and cardiac rehabilitation achievement rate. Follow-up visits are scheduled at 1, 3, 6, 9, and 12 months post-randomization.",[677,678,679,680,28,681],"Coronary Artery Bypass Grafting","Heart Valve Disease","Aortic Aneurysm","Aortic Dissection","Cardiac Surgical Procedures",[683,684,320,685,686,687,688,689,690,691],"Large Language Model","Artificial Intelligence","Postoperative Health Management","Digital Health","Medication Adherence","Cardiac Rehabilitation","MACCE","Mobile Health Application","Personalized Health Management","2026-04-08",{"date":657,"type":39},{"date":448,"type":21},{"date":130,"type":21},{"name":697,"class":46},"Beijing Anzhen Hospital"]