Coarctation of the Aorta

Researchers are evaluating the effects and mechanism of action of Losartan, an angiotensin-II receptor blocker, in treating patients with repaired coarctation of the aorta who also have high blood pressure. This Phase III trial aims to compare Losartan with Amlodipine and a placebo to better understand cardiovascular remodeling in this population. Participants with coarctation of the aorta and high blood pressure will be randomly assigned to one of three groups: Losartan, Amlodipine, or placebo. Losartan is given as a 50mg oral dose once daily, Amlodipine as 5mg once daily, and the placebo group receives capsules without active ingredients, all for a duration of 52 weeks. The study is double-blind, ensuring neither participants nor researchers know the assigned treatments during the trial. During the 52-week period, participants will undergo assessments including measuring changes in left ventricular fibrosis and exercise capacity. These evaluations occur at the start and end of the treatment period to monitor cardiovascular remodeling and physical fitness. The trial is designed to carefully monitor participants' health and responses to the treatments while aiming to advance understanding of managing repaired coarctation of the aorta with hypertension.

Researchers are investigating whether an integrated prenatal and postnatal treatment model improves outcomes for newborns with critical congenital heart disease (CCHD) compared to traditional care. This study aims to see if early diagnosis during pregnancy, combined with coordinated delivery and surgical planning, can reduce preoperative complications, optimize surgery timing, lower postoperative mortality, and enhance heart healing, especially in cases involving the right heart system. The goal is to improve treatment capacity and create guidelines suited to China's healthcare needs. The integrated model involves diagnosing CCHD by ultrasound at 22 to 26 weeks of pregnancy, transferring the mother within the hospital system before birth, and planning surgical care after multidisciplinary discussion. Newborns are transferred to the pediatric heart center immediately after birth for either urgent or elective surgery depending on their condition. Traditional care involves transferring newborns from outside hospitals with routine interventions. The study compares these two approaches by following patients from birth through surgery and afterward. Participants will be monitored during hospitalization, with evaluations of heart function, metabolic status, and survival rates over up to five years post-discharge. Researchers will assess 30-day postoperative mortality as the primary outcome and also look at heart failure before surgery, the proportion receiving integrated care, and long-term survival and reoperation rates. This real-world study uses hospital data from multiple sites to validate if the integrated prenatal-postnatal model offers better outcomes for newborns with CCHD.

Researchers are investigating the anatomical features of the aortic arch, focusing on a common variant called the common origin of the innominate and left carotid artery (CILCA), which has been linked to thoracic aortic disease (TAD). The study aims to compare these anatomical characteristics in people with and without aneurysms, collecting data from five major European cardiovascular centers. This observational study involves analyzing CT scans of the aortic arch from two groups: individuals without aneurysms requiring treatment and those with aneurysms that do require treatment. No interventions or treatments are administered; instead, the study focuses on imaging data to understand differences in aortic arch anatomy. Participants undergo aortic arch CT scans at participating centers, and researchers measure changes and differences in aortic arch anomalies from baseline within 30 days. The study tracks these anatomical features to better understand their relationship to aortic aneurysms and potential risks. The total study period extends until December 2026.

Researchers are conducting a single-center observational study to evaluate the clinical outcomes of patients who have undergone revascularization of the aorta or peripheral arteries at Asan Medical Center. This study includes both retrospective and prospective data collection on approximately 6,000 patients treated for conditions such as thoracic or abdominal aortic aneurysm, aortic dissection, penetrating aortic ulcer, and peripheral artery occlusive disease including chronic limb-threatening ischemia, claudication, and acute limb ischemia. The study collects data on treatments like EVAR, TEVAR, and PTA used for revascularization. Participants will be followed up through hospital visits or telephone calls at 1, 6, and 12 months, then at 3, 5, and up to 10 years after their procedures. The monitoring includes tracking major adverse limb events and any deaths. During follow-up visits, researchers will gather information on outcomes such as death from any cause, major adverse limb events, stroke, myocardial infarction, vascular complications, bleeding, procedure success, limb amputation, and the need for repeat interventions. The study aims to provide long-term clinical results over a 10-year period to better understand patient outcomes after these vascular procedures.

This research aims to study abdominal aortic diameter specifically in females aged 50 years or older. It evaluates biometric data of the aorta and iliac vessels along with demographic and health history related to reproductive factors such as menarche, pregnancy, infertility, and menopause. The study focuses on understanding the ultrasound measurements of the abdominal aorta and identifying female-specific risk factors for abdominal aortic diseases including aneurysms and atherosclerosis. Measurements of the aorta will be done using ultrasound by placing the probe perpendicular to the aortic axis and recording diameters in both antero-posterior and lateral directions. Both inner-to-inner and outer-to-outer diameters of the infrarenal aortic segment will be measured, along with assessments for the presence of thrombus and calcifications, and measurements of the common iliac arteries. The study follows standard clinical measurement protocols. Participants will provide biometric data and health history related to cardiovascular and reproductive health. Researchers will analyze ultrasound images and collected data to define typical abdominal aortic diameters in women and explore risk factors linked to aortic disease. The main measurement outcome is the ultrasound diameter of the infrarenal aortic segment. This observational study includes safety monitoring and will continue until July 2027, with the total participation duration varying by individual.

Researchers are evaluating the safety and early effectiveness of a new surgical technique called Branched Stented Anastomosis Frozen Elephant Trunk Repair (B-SAFER) for treating complex thoracic aortic diseases. This technique uses a specially modified endovascular stentgraft to repair multiple damaged areas of the aorta, particularly where the aortic arch is involved. The study aims to assess how well this hybrid repair method works and how safe it is for patients with conditions like thoracic aortic aneurysm, aortic dissection, or congenital aortic anomalies. The treatment involves implanting a physician-modified endovascular stentgraft designed for the proximal aorta. This simplified hybrid frozen elephant trunk repair technique is performed as part of the surgical procedure. The study focuses on device performance, including the functionality of multiple components used during the operation. Participants will undergo this device implantation as the experimental intervention. During the study, participants will be closely monitored for outcomes such as survival, stroke, paralysis, and technical success shortly after treatment. Follow-up assessments will include checking the patency and sealing of the graft components at hospital discharge or one month. Longer-term monitoring up to three years will evaluate complications like device failures, re-operations, infections, and other adverse events. This comprehensive follow-up helps to understand both the safety and durability of the B-SAFER repair over time.

Children with chronic health conditions have a higher chance of developing heart and blood vessel diseases earlier than their peers due to faster aging of these organs. Experts recommend careful monitoring and early care, but the exact causes of this increased risk are not well understood. This research seeks to better understand why these children face greater cardiovascular risks and to support future prevention efforts. The study observes children and young adults aged 6 to 25 who have chronic conditions linked to higher cardiovascular risk. It uses non-invasive methods to check the health of large blood vessels like the carotid artery and small vessels in the retina. These assessments include measuring arterial stiffness, endothelial function of the brachial artery, and retinal vessel features, all done at the start and during yearly follow-ups. Participants will undergo regular evaluations including scans of blood vessels and retinal imaging to monitor changes over time. The study measures key indicators such as arterial stiffness and retinal vessel diameter to track early signs of vascular aging. This ongoing observation helps researchers identify those at risk before obvious heart or vascular disease appears. The study is sponsored by Semmelweis University and runs until 2029, involving close monitoring without intervention.

Researchers are studying the use of Cereset Research (CR), a device-based intervention, to improve autonomic cardiovascular regulation in people aged 11 and older who have symptoms of stress, anxiety, or insomnia. This exploratory, open-label study aims to assess how CR affects heart rate variability, baroreflex sensitivity, and blood pressure variability. Secondary goals include evaluating changes in self-reported symptoms such as insomnia, depression, anxiety, and stress, along with exploring impacts in subgroups with other conditions like traumatic brain injury or PTSD. Participants will receive between 4 and 12 sessions of CR, which delivers audible tones echoing brainwave activity through sensors placed on the scalp with eyes closed. The device uses a 64-bit processing system and switches between sensor pairs during sessions to reduce interruptions and session length. This single-arm trial does not use a control group, and participants continue their usual care throughout the study. Participants will be evaluated at enrollment and through follow-up visits up to 4 to 6 weeks after the final session. Assessments include physiological measures such as blood pressure and heart rate variability, plus questionnaires on sleep, mood, anxiety, stress, traumatic stress, and quality of life. Data will be analyzed to measure changes from baseline and to explore effects in participants with coexisting symptoms or conditions. The total study duration for each participant varies depending on the number of sessions and follow-up timing.

Researchers are analyzing clinical and echocardiographic features of infants with prenatal or neonatal diagnosis of suspected aortic coarctation (CoAo). The study aims to identify signs that predict the risk of developing CoAo during the newborn period. This will help distinguish high-risk infants needing intensive care from those who may be safely discharged early. The study is observational and includes both retrospective and prospective data collection from 2000 to 2026. The study involves observing infants diagnosed with suspected or confirmed CoAo who are admitted to the Pediatric Cardiology and Cardiac Surgery Center at Policlinico di Sant'Orsola. No experimental treatments or interventions are applied; instead, researchers gather clinical data and echocardiographic results routinely collected during standard care. This approach allows the study of real-world clinical practice without altering patient management. Participants undergo routine clinical and echocardiographic evaluations. The research team collects and analyzes these data to identify predictive features of CoAo development over an average follow-up of five years. The study continues through December 2026, focusing on improving early identification of infants at risk for CoAo and informing care decisions.

This research evaluates the Renata Minima Stent System in neonates, infants, and small children with vascular narrowing conditions like pulmonary artery stenosis or aortic coarctation. It is a post-approval, multi-center, open-label study conducted in the United States to monitor the device's performance and collect real-world outcome data. Participants will receive treatment with the Renata Minima Stent System. The study involves one group of patients who have been implanted with this device. Follow-up visits will occur immediately after implantation, during any re-dilation procedures, annually, and at other standard care visits as determined by the implanting physician. The study will track key data related to the device and the procedure over a period of up to 5 years post-implant. During the study, researchers will collect information at each follow-up to analyze the device's success rate at implantation and monitor for serious adverse events related to the procedure or device. They will also track outcomes like stent re-dilation success, pressure gradients, stent migration, embolization, and any need for unplanned stent removal. Participants will be observed and assessed over several years to gather comprehensive safety and performance data.