[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100534392":3},{"organization":4,"outcomesModule":7,"designInfo":36,"detailedDescription":44,"studyPopulation":35,"armGroups":45,"interventions":56,"overallOfficials":62,"centralContacts":67,"locations":72,"responsibleParty":93,"collaborators":97,"id":116,"slug":35,"hasResults":117,"nctId":118,"briefTitle":119,"officialTitle":120,"acronym":121,"eligibilityCriteria":122,"healthyVolunteers":117,"sex":123,"minAge":124,"maxAge":125,"enrollmentInfo":126,"targetDuration":35,"studyType":129,"phases":130,"briefSummary":132,"conditions":133,"keywords":135,"overallStatus":75,"whyStopped":35,"lastUpdateSubmitDate":140,"lastUpdatePostDateStruct":141,"startDateStruct":144,"completionDateStruct":146,"leadSponsor":148,"locationsCount":149},{"fullName":5,"class":6},"Chongqing Medical University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":35},[9],{"measure":10,"description":11,"timeFrame":12},"The proportion of complete biochemical remission","Blood was drawn to measure aldosterone, renin and potassium.According to PASO criteria, outcomes of adrenalectomy for unilateral primary aldosteronism were classified into complete, partial, and absent success, for both clinical and biochemical outcomes.The proportion of complete biochemical remission according to PASO consensus criteria.","At 6 months of follow-up.",[14,16,18,20,24,28,31],{"measure":15,"description":11,"timeFrame":12},"The proportion of complete clinical remission",{"measure":17,"description":11,"timeFrame":12},"In surgical population, the proportion of complete biochemical remission",{"measure":19,"description":11,"timeFrame":12},"In surgical population, the proportion of complete clinical remission",{"measure":21,"description":22,"timeFrame":23},"Daily defined doses (DDD) of antihypertensive agents","Prescribed daily dose (DDD) of antihypertensive drugs (including MRA) in each group after 6-12 months of follow-up.","At 6-12 months of follow-up.",{"measure":25,"description":26,"timeFrame":27},"Total cost of diagnosis and treatment","After patients are determined to be enrolled, treatment costs incurred for the diagnostic process will be calculated for each subject. This includes CT,AVS or PET\u002FCT, surgery, medications, etc.","At baseline and 6 months of follow-up.",{"measure":29,"description":30,"timeFrame":27},"Health Related Quality of Life","The quality of life in our patients may be influenced in different ways.AVS is an invasive test, PET\u002FCT does not require any preparation of the patient before the test. Questionnaires of QOL-BREF will be conducted by patients before treatment and at 6-12 months follow-up in each group.This will allow for a detailed analysis of the impact of the two strategies on the quality of life of the patients.",{"measure":32,"description":33,"timeFrame":34},"Comparison of adverse events","The occurrence of adverse events was recorded, including PET\u002FCT contrast agent allergy, adrenal vein hemorrhage and related adrenal insufficiency, hypertensive emergency, anaphylactic shock, venous thrombosis, pulmonary embolism, etc.","At baseline and 6 month of follow-up.",null,{"allocation":37,"interventionModel":38,"interventionModelDescription":35,"primaryPurpose":39,"observationalModel":35,"timePerspective":35,"maskingInfo":40},"RANDOMIZED","PARALLEL","DIAGNOSTIC",{"masking":41,"maskingDescription":35,"whoMasked":42},"SINGLE",[43],"PARTICIPANT","This is a randomized study involving patients with primary aldosteronism (PA) patients with adrenal nodule (≥1cm) who completed AVS or 68Ga-Pentixafor PET\u002FCT.We will enroll 320 PA patients with adrenal nodule (≥1cm) .All paticipants will be randomized into 68Ga-Pentixafor PET\u002FCT group(Intervention group) and AVS group(Control group) to compare the long-term outcomes of patients with PA.",[46,52],{"label":47,"type":48,"description":49,"interventionNames":50},"68Ga-Pentixafor PET\u002FCT group","EXPERIMENTAL","Patients divided into 68Ga-Pentixafor PET\u002FCT group need to undergo 68Ga-Pentixafor PET\u002FCT examination and guide subsequent treatment based on the results",[51],"Diagnostic Test: 68Ga-Pentixafor PET\u002FCT",{"label":53,"type":54,"description":55,"interventionNames":35},"AVS group","NO_INTERVENTION","Patients divided into AVS group need to undergo AVS to guide subsequent treatment based on the results",[57],{"type":58,"name":59,"description":60,"armGroupLabels":61,"otherNames":35},"DIAGNOSTIC_TEST","68Ga-Pentixafor PET\u002FCT","The patients had a normal diet with no special preparation before 68Ga-Pentixafor PET\u002FCT imaging. The dosage of intravenously injected 68Ga-Pentixafor was calculated based on the patient's weight (1.85 MBq \\[0.05mCi\\]\u002Fkg). Local PET\u002FCT scanning of the upper abdomen was performed on a hybrid PET\u002FCT scanner at 10 minutes after the injection of the intravenous tracer, respectively.",[47],[63],{"name":64,"affiliation":65,"role":66},"Qifu Li, PhD","the Chongqing Primary Aldosteronism Study (CONPASS) Group","STUDY_CHAIR",[68],{"name":64,"role":69,"phone":70,"phoneExt":35,"email":71},"CONTACT","+86 023-89011552","liqifu@yeah.net",[73],{"facility":74,"status":75,"city":76,"state":77,"zip":78,"country":79,"countryCode":80,"cosmosGeoPoint":81,"geoPoint":86,"contacts":87},"The First Affilated Hospital of Chongqing Medical University","RECRUITING","Chongqing","Chongqing Municipality","400016","China","CN",{"type":82,"coordinates":83},"Point",[84,85],106.55771,29.56026,{"lat":85,"lon":84},[88,90],{"name":64,"role":69,"phone":89,"phoneExt":35,"email":71},"023-89011552",{"name":91,"role":69,"phone":89,"phoneExt":35,"email":92},"Ying Song, M.D.","shuiyunying@126.com",{"type":94,"investigatorFullName":95,"investigatorTitle":96,"investigatorAffiliation":5,"oldNameTitle":35,"oldOrganization":35},"SPONSOR_INVESTIGATOR","Qifu Li","Primary investigator",[98,100,102,104,106,108,110,112,114],{"name":99,"class":6},"The Affiliated Hospital Of Southwest Medical University",{"name":101,"class":6},"West China Hospital",{"name":103,"class":6},"Tongji Hospital",{"name":105,"class":6},"The First Affiliated Hospital of Zhengzhou University",{"name":107,"class":6},"The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School",{"name":109,"class":6},"The Third Xiangya Hospital of Central South University",{"name":111,"class":6},"Second Affiliated Hospital, School of Medicine, Zhejiang University",{"name":113,"class":6},"Changzhi Medical College",{"name":115,"class":6},"Xiangya Hospital of Central South University","100534392",false,"NCT06238232","Outcome of 68Ga-Pentixafor PET\u002FCT Versus Adrenal Vein Sampling in Primary Aldosteronism","68Ga-Pentixafor PET\u002FCT Versus Adrenal Vein Sampling to Determine Treatment in Primary Aldosteronism: A Multicenter Randomized Clinical Trial","GAPA","Inclusion Criteria:\n\n(1)Getting the written informed consent (2)ARR ≥20 (pg\u002Fml)\u002F (μIU\u002Fml) or ARR ≥ 30(ng\u002FdL)\u002F(ng\u002Fml\u002Fhr) plus at least one positive PA confirmatory test (CCT, SSIT).\n\n(3)Patients who are willing to undergo surgery. (4)Patients with hypertension aged 18-70 years. (5)CT or MRI scan of the adrenal glands with nodule (≥1cm). Exclusion criteria\n\n1. Combined with autonomous cortisol secretion, cortisol after 1mg dexamethasone suppression test (DST) ≥50 nmol\u002Fl.\n2. PA patients who meet the by-passing AVS criteria \\[i.e., younger than 35 years old, spontaneous hypokalemia, adrenal CT indicated unilateral low-density adenoma (≥1cm), plasma aldosterone \\>300pg\u002Fml\\]\n3. Suspicion of familial hyperaldosteronism or Liddle syndrome. \\[i.e., age \\\u003C20 years, hypertension and hypokalemia, or with family history\\]\n4. Suspicion of pheochromocytoma or adrenal carcinoma.\n5. Patients with actively malignant tumor.\n6. Patients who have adrenalectomy history or with adrenocortical insufficiency.\n7. Long-term use of glucocorticoids.\n8. Pregnant or lactating women; with alcohol or drug abuse and mental disorders.\n9. Congestive heart failure with New York Heart Association (NYHA) Functional Classification III or IV; History of serious cardiovascular or cerebrovascular disease (angina, myocardial infarction or stroke) in the past 3 months; Severe anemia (Hb\\\u003C60g\u002FL); Serious liver dysfunction or chronic kidney disease aspartate aminotransferase (AST) or alanine transaminase (ALT) \\>3 times the upper limit of normal, or estimated glomerular filtration rate (eGFR) \\\u003C 30 ml\u002Fmin\u002F1.73 m2); Systemic Inflammatory Response Syndrome (SIRS); Uncontrolled diabetes (FBG≥13.3 mmol\u002FL); Obesity (BMI≥35 kg\u002Fm²) or Underweight (BMI≤18 kg\u002Fm²); Untreated aneurysm; Other comorbidity potentially interfering with treatment","ALL","18 Years","70 Years",{"count":127,"type":128},320,"ESTIMATED","INTERVENTIONAL",[131],"NA","To compare the 68Ga-Pentixafor PET\u002FCT and adrenal vein sampling on the long-term outcomes of primary aldosteronism (PA) patients with adrenal nodule (≥1cm)",[134],"Primary Aldosteronism",[136,137,59,138,139],"Primary aldosteronism;","Adrenal venous sampling","outcome","multicenter randomized","2024-04-27",{"date":142,"type":143},"2024-04-30","ACTUAL",{"date":145,"type":143},"2024-01-09",{"date":147,"type":128},"2027-12-31",{"name":95,"class":6},1]