Renal Artery Stenosis

Researchers are evaluating the safety and initial effectiveness of HyperQureTM, a laparoscopic renal denervation therapy, in adults with resistant hypertension who are taking three or more blood pressure medications including a diuretic. This first-in-human, single-arm study aims to overcome limitations seen with catheter-based renal denervation by using a device that delivers energy around the renal artery from outside the vessel, potentially allowing more complete nerve treatment and reducing procedural risks. The study involves laparoscopic renal denervation using the HyperQure Renal Denervation System, which applies radiofrequency energy around the renal arteries through a minimally invasive approach under general anesthesia. Ten eligible adults will undergo this procedure, targeting specific renal artery areas planned by CT angiography. Participants will be monitored for safety and blood pressure changes over a 12-month period following the procedure. During the study, participants will have assessments including CT angiograms, blood tests, office and 24-hour ambulatory blood pressure measurements, and quality of life questionnaires at multiple time points. Researchers will track changes in systolic and diastolic blood pressure, incidence of adverse events, and heart rate from baseline up to one year. The main outcome is the change in 24-hour ambulatory systolic blood pressure measured three months after the procedure. Safety and blood pressure will continue to be monitored through 12 months post-treatment.

Researchers are evaluating a preventive, multidisciplinary primary care intervention designed around a therapeutic garden to assess its acceptability among patients with cardio-neurovascular diseases. This study focuses on individuals suffering from various vascular conditions, including atrial fibrillation, heart failure (NYHA Class II), cardiomyopathies, ischemic stroke, and resistant hypertension. The main goal is to understand how patients and those involved in their care respond to this novel intervention. The intervention consists of a 6-month program that includes gardening activities, adapted physical exercise, nutritional workshops, and questionnaires to gather feedback. Participants may either take part in this multidisciplinary preventive action or choose not to receive the intervention but still complete questionnaires explaining their reasons. The study compares these two groups to identify acceptance rates and factors influencing participation. Participants will be involved for six months, during which their acceptance of the intervention and any obstacles or facilitators will be recorded. Researchers will assess the impact of the program through questionnaires and follow-up evaluations. The study monitors participants from enrollment through the end of treatment, aiming to gather comprehensive data on the intervention's feasibility and effects on patients with cardio-neurovascular conditions.

Researchers are conducting a prospective national registry in Denmark to observe and collect data on percutaneous transluminal renal angioplasty (PTRA) in patients who have high-risk renovascular hypertension. This registry includes patients selected based on common national criteria and follows a standardized protocol across three Danish centers offering PTRA. The study aims to evaluate changes in blood pressure and other health outcomes after the procedure. The intervention being studied is percutaneous transluminal renal angioplasty, including angioplasty with stenting, especially in patients with fibromuscular dysplasia. Additional treatments such as antiplatelet therapy, cholesterol-lowering drugs, antihypertensive medications, and lifestyle measures like smoking cessation, diet, and physical activity are used according to the physician's discretion. The study monitors patients over time following their PTRA treatment. Participants undergo regular assessments including 24-hour ambulatory blood pressure monitoring and kidney function tests. The primary outcome measured is the change in systolic and diastolic blood pressures 24 months after PTRA in patients with elevated baseline blood pressure. Secondary outcomes include blood pressure changes at multiple time points, adjustments in antihypertensive treatment, kidney function changes, clinical and safety endpoints. Follow-up evaluations occur up to 60 months post-treatment to monitor long-term effects and safety.

Researchers are evaluating the long-term safety and effectiveness of the NOVA intracranial drug-eluting stent system in patients with intracranial atherosclerotic stenosis. This study is a prospective, multi-center, single-arm clinical trial conducted across about 50 centers in China, aiming to include 1000 participants who are suitable candidates for stent angioplasty. The trial will run from December 2022 to December 2030, focusing on patients with significant artery narrowing in the brain. All participants will receive the NOVA drug-eluting stent, which is designed to treat intracranial artery stenosis with a sirolimus-eluting coating and a rapid exchangeable balloon. The study includes ten visits starting from preoperative screening, the operation day, then follow-ups at 30 days, 3 months, 6 months, 1 year, and annually up to 5 years after the procedure. This schedule allows researchers to closely monitor the device's performance and patient outcomes over time. Participants will undergo various assessments during these visits, including evaluations for stroke, death, ischemic events, and revascularization related to the treated artery. Other measures include rates of stroke in different brain regions, transient ischemic attacks, restenosis, bleeding events, and quality of life assessments using tools like the modified Rankin Scale and EuroQol-5D. Safety, device defects, and long-term outcomes will be carefully tracked throughout the study period, which lasts up to five years after the operation.

Researchers are evaluating how people with Spontaneous Coronary Artery Dissection (SCAD) and/or Fibromuscular Dysplasia (FMD) respond to different types and intensities of aerobic and resistance exercise. This study aims to understand the effects on heart and lung function, blood flow, and symptoms during exercise in this group of patients. The trial is a single-center, single-arm prospective clinical trial sponsored by Mayo Clinic. Participants with a history of SCAD and/or FMD will complete three separate exercise tests spaced at least 48 hours apart. These tests include a symptom-limited cardiopulmonary exercise test on a cycle, two stages of submaximal constant power cycling at moderate and heavy intensity, and a series of six resistance exercises involving chest press, lateral raises, abdominal crunches, planks, leg press, and weighted lunges. The exercises are designed to study different intensities and types of physical activity. During the study visits, researchers will measure changes in blood pressure at multiple time points, assess functional status and physical activity levels using questionnaires like the Dartmouth COOP Functional Assessment Chart, Duke Activity Index Status, and International Physical Activity Questionnaire Short Form. They will also track perceived exertion and blood lactate levels before and during exercise. The study includes careful monitoring of participants' responses to exercise and lasts for the duration of the three test sessions.

Researchers are investigating how minocycline affects blood pressure in adults with treatment-resistant hypertension. The study aims to determine to what degree minocycline lowers blood pressure and whether these effects involve changes in the gut microbiota, gut leakiness, systemic inflammation, neuroinflammation, or a combination of these factors. This phase 4 clinical trial includes a neuroimaging substudy to explore brain-related impacts. Participants will be randomly assigned to receive either minocycline hydrochloride 100 mg twice daily or a matching placebo, both given for 3 months. The study includes three visits: screening, randomization, and a 3-month follow-up. Those in the neuroimaging substudy will undergo PET/MR imaging at each visit. Throughout the study, participants will undergo medical exams, behavioral questionnaires, blood tests for various biomarkers, urine and saliva tests to assess adherence, stool sample analysis for gut microbiota, and blood pressure monitoring including unattended office and 24-hour ambulatory measurements. At the final visit, blood will also be tested for drug concentration to confirm treatment adherence. The main outcomes measured include 24-hour systolic blood pressure, gut microbiome changes, gut inflammation and leakiness, and neuroinflammation.

Researchers are evaluating the baroloop system, a device implanted to stimulate the vagus nerve, for treating adults with hypertension that does not respond well to medication. The study aims to find out if the baroloop is safe, including checking for serious medical problems or death, and if it effectively lowers blood pressure in participants. This is a multicenter clinical trial sponsored by neuroloop GmbH. Participants will have the baroloop device implanted and will attend follow-up visits at 14 days, 3 months, 6 months, 12 months, 18 months, and 24 months after implantation. During these visits, device settings may be adjusted, and various assessments related to the study will be performed. Participants will also answer questions about their quality of life throughout the study period. During the trial, researchers will monitor safety and performance outcomes, especially focusing on safety and blood pressure changes 6 months after stimulation begins. Participants will undergo regular clinical evaluations and provide feedback on their well-being. The total duration of participation includes multiple visits over two years, ensuring close monitoring and adjustment of the device as needed.

Researchers are conducting a large, international observational study called the Canadian SCAD Study to understand spontaneous coronary artery dissection (SCAD), a condition that mainly affects young women without usual heart risk factors and can lead to heart attacks or death. SCAD is often misdiagnosed due to limits of current tests, so this study aims to better understand the condition's natural history, predisposing factors, and treatments over time. The study will enroll about 3,000 patients diagnosed with SCAD from multiple centers in Canada, the United States, and other countries. Participants will be followed for up to 10 years to track cardiovascular events. A genetic sub-study involves a one-time saliva sample collection. The study uses electronic consent for wide geographic participation and collects detailed health history and investigations related to SCAD. Participants will undergo detailed baseline assessments, including history and diagnostic testing, and will be monitored regularly for heart-related outcomes both during hospitalization and over the long term. The main outcomes measured include cardiovascular events during hospital stay and up to 10 years later. Secondary outcomes include arterial healing and success of coronary procedures. This long-term follow-up aims to improve knowledge of SCAD and guide future treatment trials.

Researchers are studying patients with atherosclerotic carotid stenosis, including both symptomatic patients with stenosis over 50% and asymptomatic patients with stenosis 80% or greater. This trial compares early neurological outcomes using two different embolic protection devices combined with the CGuard microNet covered stent. The purpose is to evaluate whether distal or proximal embolic protection device placement offers better results, expanding on previous findings that showed CGuard stent implantation had advantages over classical stents using distal protection. Participants will undergo carotid artery stenting with one of two devices: the Emboshield NAV6 distal embolic protection system plus the CGuard stent, or the Mo.Ma proximal cerebral protection device plus the CGuard stent. The study groups are randomized and unblinded, and both devices aim to reduce embolic events during the stenting procedure. The trial began in November 2021 and will continue until January 2027. During the study, participants will receive neurological assessments and brain imaging to detect ischemic lesions within 24 to 48 hours after the procedure. The primary outcome is the determination of these ischemic lesions, while secondary outcomes include monitoring major adverse cardiac and cerebrovascular events during and shortly after the procedure. Participants must consent to follow-up visits and procedures as part of the trial involvement.

Researchers are investigating the relationship between blood pressure changes and catecholamine levels in the adrenal venous and peripheral venous blood of patients with primary aldosteronism (PA) who have high blood pressure and undergo percutaneous selective adrenal artery embolization (SAAE). This study aims to understand why some patients experience large blood pressure spikes during SAAE while others do not, and to explore the possible mechanisms behind these blood pressure fluctuations caused by the treatment. The study involves collecting blood samples from two groups: one from the adrenal vein and another from the peripheral vein in patients with PA undergoing SAAE. This minimally invasive procedure blocks blood flow to the affected adrenal gland to reduce excess aldosterone production. Blood pressure and hormone levels including norepinephrine, adrenaline, dopamine, renin, aldosterone, sodium, and potassium will be measured immediately and at intervals up to 30 minutes after embolization. The study will capture detailed blood pressure readings before and after the procedure using invasive and 24-hour monitoring. Participants will be monitored closely during the procedure with multiple blood and blood pressure measurements taken at specific times. Researchers will analyze changes in blood pressure and hormone levels to better understand the physiological effects of SAAE. The study is observational, following patients who meet strict diagnostic and blood pressure criteria for PA. Participants will provide informed consent and be observed until the study concludes at the end of 2026. The findings aim to improve knowledge about blood pressure control during this minimally invasive treatment for PA.