Hyperaldosteronism

Researchers are evaluating the accuracy of two diagnostic methods, 68Ga-Pentixafor PET/CT and adrenal venous sampling (AVS), in identifying the subtype of primary aldosteronism (PA) concurrent with autonomous cortisol secretion (ACS) in patients with adrenal nodules. This prospective, multicenter, randomized crossover trial aims to compare the diagnostic performance of these methods based on biochemical and clinical remission outcomes, focusing on whether 68Ga-Pentixafor PET/CT is not less accurate than AVS. The main goal is to guide treatment decisions effectively based on these diagnostic results. Participants are randomly assigned to one of two groups: one group undergoes 68Ga-Pentixafor PET/CT first followed by AVS, and the other group undergoes AVS first followed by 68Ga-Pentixafor PET/CT. Treatment strategies are then guided by the diagnostic findings. Both interventions are diagnostic tests used to determine unilateral primary aldosteronism, with specific criteria for diagnosis based on imaging and sampling results. This crossover design allows each patient to receive both diagnostic methods in different orders. During the study, participants will be monitored with a primary focus on the proportion of complete biochemical remission at 6 months postoperatively. Additional assessments include clinical remission rates and diagnostic accuracy in the surgical population. The study includes follow-up visits at 6 months after treatment to evaluate outcomes. Safety and treatment effectiveness are monitored throughout the trial, which is expected to last until the end of 2029.

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 investigating the gut microbiome in people with various serious chronic diseases such as liver cancer, gastric cancer, pancreatic cancer, lung cancer, nasopharyngeal cancer, hypertension, acute coronary syndrome, primary aldosteronism, epilepsy, chronic kidney disease, and subclinical hypothyroidism. The study aims to better understand how the gut microbiota differs across these diseases and regions and to explore the impact of these differences on microbiota-based diagnostic models. This multicenter observational study addresses the challenges caused by variability in previous research and seeks to validate microbial biomarkers in large population-based groups. Participants include patients diagnosed with one of the target diseases and age- and sex-matched healthy controls. Each participant will provide information on demographics, body measurements, lifestyle, diet, medications, diseases, and biochemistry. Samples of feces, saliva, urine, and blood will be collected from all participants. No treatments or interventions are administered, as this is an observational study. The study is designed to enroll 500 patients and 500 controls for each disease group. Participants will be involved in a one-time assessment where researchers will collect biological samples and detailed health and lifestyle information. The main outcome measure is the baseline microbiome profile, with additional assessments including baseline biochemistry, metabonomics, and proteomics. The study includes adults aged 18 to 75 years living in the hospital's province for at least three years. The entire study aims to improve understanding of gut microbiota patterns across critical chronic diseases and their diagnostic potential.

Researchers are conducting a multicenter, randomized, double-blind, placebo-controlled phase II clinical trial to evaluate the efficacy and safety of HRS-1780 in adults diagnosed with primary aldosteronism. The study aims to compare HRS-1780 against a placebo in 60 participants to better understand its effects on blood pressure and related health measures. Participants will be randomly assigned to receive either HRS-1780 tablets or a placebo. The treatment period lasts up to 8 weeks, during which changes in systolic and diastolic blood pressure, both in the office and via 24-hour ambulatory monitoring, will be assessed. The study also monitors serum potassium and sodium levels, potassium supplementation needs, and kidney function during this time. During the trial, participants will undergo regular blood pressure measurements, laboratory tests for electrolytes and kidney function at weeks 2, 4, and 8, and monitoring of any adverse effects. The primary measure is the change from baseline in office systolic blood pressure by week 8. Safety and efficacy will be closely followed throughout the study, which is scheduled to complete by November 2026.

This clinical trial investigates the safety and recovery benefits of tubeless laparoscopic adrenalectomy in patients undergoing adrenal gland removal surgery. The study aims to answer whether avoiding drainage tubes after surgery helps patients recover more quickly, focusing on pain, the time to first get out of bed, and the recovery of intestinal function. It is a prospective, single-center, randomized controlled study enrolling 200 patients who need laparoscopic adrenalectomy. Participants are randomly assigned to one of two groups: one group receives surgery without drainage tubes (tubeless group), and the other group has drainage tubes placed after surgery (drainage group). The study compares outcomes such as pain scores, blood tests, and recovery indicators between these groups. Follow-up includes adrenal ultrasounds at one and six months post-surgery to monitor recovery and safety. During the study, participants will have blood tests and assessments of pain, time to mobilization, and intestinal function for the first three days after surgery. Researchers will also monitor for complications like fever and wound infections. Follow-up ultrasound exams at one and six months will help evaluate longer-term recovery. The trial uses block randomization and collects data to assess whether tubeless surgery promotes faster and safer recovery after adrenalectomy.

Researchers are evaluating the safety, tolerability, and effectiveness of baxdrostat compared to a placebo in adults aged 18 years and older with Primary Aldosteronism (PA). This Phase III, multicenter, randomized, double-blind, placebo-controlled study aims to assess how baxdrostat affects seated blood pressure and the normalization of the Renin Angiotensin Aldosterone System (RAAS). The trial includes participants with or without prior treatment using Mineralocorticoid Receptor Antagonists (MRAs) or potassium-sparing diuretics. Participants will receive either baxdrostat or a matching placebo tablet taken orally once daily. The dose may be increased after two weeks depending on how the participant responds and tolerates the treatment. The study is planned to take place globally across about 90 centers in 12 countries. Treatments will be compared over the course of the study to evaluate their effects on blood pressure and RAAS normalization. During the study, participants will have regular assessments including measurements of seated systolic blood pressure and monitoring of RAAS system function at week 8 and week 52. Blood potassium and aldosterone levels will also be tracked. Safety and tolerability will be monitored throughout the study. The total participation period includes initial treatment and follow-up assessments to observe changes and any side effects over time.

Researchers are investigating the causes and development of adrenal tumors, which include adrenocortical carcinoma, Cushing syndrome, Conn syndrome, and pheochromocytoma. The study aims to better understand how these tumors form and to evaluate new treatment options for patients with malignant adrenal tumors, addressing the limited current therapies available. This observational research is sponsored by the University of Wuerzburg and has been ongoing since 2002. Participants in the study may provide tumor material and related biological samples if they have adrenal tumors. Additionally, biological samples are collected from patients without adrenal tumors to serve as comparison controls. The research does not involve experimental treatments but focuses on collecting and analyzing biospecimens to explore tumor biology and potential therapies. Throughout the study, participants contribute by providing tumor and biosample materials. Researchers analyze these samples to study tumor characteristics and evaluate possible new treatments. There are no specific outcome measures listed. The study is observational, with no assigned treatments, and aims to gather information to support future therapeutic developments. Participants' involvement duration varies, and the study is expected to continue until December 2032.

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.

Primary aldosteronism (PA) is a leading cause of secondary hypertension and affects millions worldwide. This study evaluates a new imaging method, Al18F-NOTA-Pentixafor PET/CT, which targets a receptor called CXCR4 found on aldosterone-producing adenomas. Researchers aim to assess how this imaging works, its safety, and how well it helps guide surgery decisions for patients with PA in a prospective, single-center trial. Participants will receive an intravenous injection of the Al18F-NOTA-Pentixafor tracer. After injection, PET and CT scans will be performed within 45-90 minutes to visualize CXCR4-positive lesions. The study will monitor tracer distribution and radiation dose and track diagnostic accuracy and surgical outcomes guided by this imaging over 1 to 1.5 years, including a 6-month follow-up after surgery. Throughout the study, participants will undergo safety assessments from the time of tracer injection up to 24 hours afterward. Researchers will also evaluate diagnostic accuracy based on clinical or pathological diagnoses at 6 months post-imaging and surgical results. Additional measurements include organ uptake of the tracer and radiation dose, monitored up to 6 months after study completion. Participation involves imaging procedures, follow-up visits, and adherence to contraception requirements when applicable.

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.