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Primary aldosteronism (PA) is a major cause of secondary hypertension, yet its optimal diagnosis and management remain challenging. This study comprehensively evaluates adrenal venous sampling (AVS), addressing key clinical, technical, and methodological issues, and aims to clarify the relationship between AVS-guided management and long-term clinical and biochemical outcomes to optimize patient care and prognosis.
Primary aldosteronism (PA) is one of the most common causes of secondary hypertension, yet its optimal diagnostic and therapeutic strategies remain challenging. Adrenal venous sampling (AVS) is regarded as the gold standard for subtype differentiation; however, important clinical, technical, and methodological issues have not been systematically addressed. This study is designed to comprehensively evaluate AVS and its clinical implications, aiming to elucidate the relationship between AVS-guided diagnosis and management of PA and long-term clinical and biochemical outcomes, while refining AVS protocols, standardizing clinical practice, optimizing therapeutic decision-making, and ultimately improving patient management and prognosis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adrenal Venous Sampling | Patients with Primary Aldosteronism (PA) undergoing Adrenal Venous Sampling via antecubital approach or femoral approach to discriminate PA forms with unilateral from bilateral excess aldosterone production. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| adrenal venous sampling | Procedure | Patients with Primary Aldosteronism (PA) undergoing Adrenal Venous Sampling via antecubital approach or femoral approach to discriminate PA forms with unilateral from bilateral excess aldosterone production. |
| Measure | Description | Time Frame |
|---|---|---|
| Major adverse cardiovascular events (MACE) at 1-year follow-up | Incidence of major adverse cardiovascular events (MACE) at 1-year follow-up, including stroke, heart failure, severe arrhythmias, renal failure, myocardial infarction, and death. | 1 year after AVS procedure |
| Measure | Description | Time Frame |
|---|---|---|
| The success rate of left adrenal venous sampling | Successful sampling will be defined by high selectivity index (cortisol in the adrenal vein/cortisol in inferior vena cava >2 without ACTH simulation) | At AVS procedure |
| The success rate of right adrenal venous sampling |
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Inclusion Criteria:
Exclusion Criteria:
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All patients with confirmed primary aldosteronism underwent adrenal venous sampling.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hui Dong, MD | Contact | 86-010-88322385 | donghui666@sina.com | |
| Xiongjing Jiang, MD | Contact | 86-010-88322387 | jiangxiongjing@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Hui Dong, MD | Fuwai Hospital, National Center for Cardiovascular Disease, Chinese Academy of Medical Sciences and Peking Union Medical College | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The first affiliated hospital of USTC | Recruiting | Hefei | Anhui | 230036 | China |
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Successful sampling will be defined by high selectivity index (cortisol in the adrenal vein/cortisol in inferior vena cava >2 without ACTH simulation) |
| At AVS procedure |
| The success rate of bilateral adrenal venous sampling | Successful sampling will be defined by high selectivity index (cortisol in the adrenal vein/cortisol in inferior vena cava >2 without ACTH simulation) | At AVS procedure |
| Selection of intraoperative catheter | Types of catheter at the time of Adrenal Venous Sampling via antecubital approach or femoral approach | At AVS procedure |
| Time of the procedure | Time of the procedure | At AVS procedure |
| Time of fluoroscopy | Time of fluoroscopy | At AVS procedure |
| The contrast agent dosage | The contrast agent dosage | At AVS procedure |
| the incidence of complications | Complications related to adrenal vein cannulations (adrenal vein hematoma, inferior vena cava dissection, puncture site hematoma, etc) | 1 week after AVS procedure |
| the cost of the procedure | the cost of the procedure | At AVS procedure |
| Change in 24-hour ambulatory systolic blood pressure | The difference in average systolic blood pressure measured by 24-hour ambulatory blood pressure monitoring (ABPM) between baseline and each follow-up time point. | At 1, 3, 6, 12, and 18 months; and 2, 3, 4, 5, and 10 years after treatment |
| Change in 24-hour ambulatory diastolic blood pressure | The difference in average diastolic blood pressure measured by 24-hour ambulatory blood pressure monitoring (ABPM) bewteen baseline and each follow-up time point. | At 1, 3, 6, 12, and 18 months; and 2, 3, 4, 5, and 10 years after treatment |
| Change in office systolic blood pressure | The difference in systolic blood pressure measured during clinic visits (office blood pressure) between baseline and each follow-up time point | At 1, 3, 6, 12, and 18 months; and 2, 3, 4, 5, and 10 years after treatment |
| Change in office diastolic blood pressure | The difference in diastolic blood pressure measured during clinic visits (office blood pressure) between baseline and each follow-up time point | At 1, 3, 6, 12, and 18 months; and 2, 3, 4, 5, and 10 years after treatment |
| Change in antihypertensive medication burden | The change in the number and/or dosage of antihypertensive medications taken by patients between baseline and each follow-up time point | At 1, 3, 6, 12, and 18 months; and 2, 3, 4, 5, and 10 years after treatment |
| Change in urinary albumin-to-creatinine ratio (UACR) | The difference in urinary albumin-to-creatinine ratio measured at baseline and at each follow-up time point | At 1, 3, 6, 12, and 18 months; and 2, 3, 4, 5, and 10 years after treatment |
| Change in left ventricular mass index (LVMI) | The change in left ventricular mass index, as assessed by echocardiography, from baseline to each follow-up time point. | At 1, 3, 6, 12, and 18 months; and 2, 3, 4, 5, and 10 years after treatment |
| Change in pulse wave velocity (PWV) from baseline | The change in pulse wave velocity measured between baseline and each follow-up time point。 | At 1, 3, 6, 12, and 18 months; and 2, 3, 4, 5, and 10 years after treatment |
| Clinical Outcome According to Primary Aldosteronism Surgical Outcome (PASO) Criteria | Clinical outcomes will be assessed at each follow-up visit afteradrenal surgery according to the PASO consensus criteria. Outcomes will be categorized as: (1)Complete clinical success: normal blood pressure without the need for any antihypertensive medication. (2)Partial clinical success: improvement in blood pressure and/or a reduction in the number or dosage of antihypertensive medications. (3)Absent clinical success: no improvement in blood pressure or antihypertensive medication burden. | At 6, 12, and 18 months; and 2, 3, 4, 5, and 10 years after surgery |
| Biochemical Outcome According to Primary Aldosteronism Surgical Outcome (PASO) Criteria | Biochemical outcomes will be assessed at each follow-up visit after adrenal surgery according to the PASO consensus classification. Outcomes will be categorized as:(1)Complete biochemical success: normal serum potassium levels and a normalized aldosterone-to-renin ratio (ARR) without the need for potassium supplementation.(2)Partial biochemical success: improvement in biochemical parameters without full normalization.(3)Absent biochemical success: no improvement in biochemical markers compared to baseline. | At 6, 12, and 18 months; and 2, 3, 4, 5, and 10 years after surgery |
| Major adverse cardiovascular events (MACE) | Incidence of major adverse cardiovascular events (MACE), including stroke, heart failure, severe arrhythmias, renal failure, myocardial infarction, and death. | At 6 and 18 months; and 2, 3, 4, 5, and 10 years after AVS procedure |
| Chuiyangliu Hospital affiliated to Tsinghua University | Recruiting | Beijing | Beijing Municipality | 100022 | China |
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| China-Japan Friendship Hospital | Recruiting | Beijing | Beijing Municipality | 100029 | China |
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| Peking University First Hospital | Recruiting | Beijing | Beijing Municipality | 100034 | China |
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| Fuwai Hospital, National Center for Cardiovascular Disease, Chinese Academy of Medical Sciences and Peking Union Medical College | Recruiting | Beijing | Beijing Municipality | 100037 | China |
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| Peking University People's Hospital | Recruiting | Beijing | Beijing Municipality | 100044 | China |
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| Beijing Luhe Hospital, Capital Medical University | Recruiting | Beijing | Beijing Municipality | 101100 | China |
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| Chongqing University Central Hospital | Recruiting | Chongqing | Chongqing Municipality | 400000 | China |
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| Chongqing General Hospital | Recruiting | Chongqing | Chongqing Municipality | 401147 | China |
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| People's Hospital Affiliated to ChongqingThree Gorges Medical college | Recruiting | Chongqing | Chongqing Municipality | 404100 | China |
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| First Affiliated Hospital, Fujian Medical University, Fuzhou, China, | Recruiting | Fuzhou | Fujian | 0591-87982222 | China |
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| Cardiovascular Hospital Xiamen University | Recruiting | Xiamen | Fujian | 361016 | China |
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| Lanzhou University Second Hospital | Recruiting | Lanzhou | Gansu | 730000 | China |
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| The Forth People's Hosptal of Nanhai District of Foshan City | Recruiting | Foshan | Guangdong | 528211 | China |
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| Guangdong Provincial People's Hospital (Guangdong Academy of Medical Sciences) | Recruiting | Guangzhou | Guangdong | 510080 | China |
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| Fuwai Hospital Chinese Academy of Medical Sciences, Shenzhen | Recruiting | Shenzhen | Guangdong | 518000 | China |
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| Shenzhen Third People's Hospital,Shenzhen, Guangdong Province 518112, China | Recruiting | Shenzhen | Guangdong | 518112 | China |
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| Shenzhen Dapeng New District Kuiyong People's Hospital | Recruiting | Shenzhen | Guangdong | 518116 | China |
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| The First Affiliated Hospital of Guangxi Medical University | Recruiting | Nanning | Guangxi | 530000 | China |
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| The Second Affliated Hospital Of GuangXi Medical Univesity | Recruiting | Nanning | Guangxi | 530007 | China |
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| Nanning Third People's Hospital | Recruiting | Nanning | Guangxi | 547000 | China |
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| Guizhou Provincial People's Hospital, Guiyang, Guizhou 550002, China. | Recruiting | Guiyang | Guizhou | 550002 | China |
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| The Affiliated Hospital of Guizhou Medical University | Recruiting | Guiyang | Guizhou | 550004 | China |
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| The Second Affiliated Hospital Of Guizhou Medical University | Recruiting | Kaili | Guizhou | 556000 | China |
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| Hainan General Hospital, Department of Endocrinology | Recruiting | Haikou | Hainan | 570311 | China |
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| Hainan General Hospital, Department of Cardiology | Recruiting | Hainan | Hainan | 570311 | China |
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| Tangshan hongci Hospital | Recruiting | Tangshan | Hebei | 063000 | China |
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| The First Affiliated Hospital of Harbin Medical University | Recruiting | Harbin | Heilongjiang | 150001 | China |
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| The Second Affiliated Hospital of Harbin Medical University | Recruiting | Harbin | Heilongjiang | 150086 | China |
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| Kai Feng the Peoples Hospital | Recruiting | Kaifeng | Henan | 475002 | China |
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| Fuwai Central China Cardiovascular Hospital | Recruiting | Zhengzhou | Henan | 450000 | China |
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| Henan Provincial People's Hospital | Recruiting | Zhengzhou | Henan | 450003 | China |
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| Zhengzhou Central Hospital Affiliated to Zhengzhou University | Recruiting | Zhengzhou | Henan | 450007 | China |
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| Zhengzhou Yihe Hospital | Recruiting | Zhengzhou | Henan | 450018 | China |
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| The First Affiliated Hospital of Zhengzhou University | Recruiting | Zhengzhou | Henan | 450052 | China |
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| Zhoukou Central Hospital | Recruiting | Zhoukou | Henan | 466000 | China |
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| Renmin Hospital of Wuhan University | Recruiting | Wuhan | Hubei | 430060 | China |
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| Xiangyang Central Hospital, Affiliated Hospital of Hubei University of Arts and Science | Recruiting | Xiangyang | Hubei | 441021 | China |
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| Yichang Central People's Hospital | Recruiting | Yichang | Hubei | 43000 | China |
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| Zhuzhou Hospital Affiliated to Xiangya School of Medicine,Central South University | Recruiting | Zhuzhou | Hunan | 412000 | China |
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| Xuzhou Central Hospital, Jiangsu | Recruiting | Xuzhou | Jiangsu | 221009 | China |
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| The First Affiliated Hospital of Gannan Medical University | Recruiting | Ganzhou | Jiangxi | 341000 | China |
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| Second Affiliated Hospital of Nanchang University | Recruiting | Nanchang | Jiangxi | 330006 | China |
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| Jiangxi Provincial People's Hospital (The First Affiliated Hospital of Nanchang Medical College) | Recruiting | Nanchang | Jiangxi | 330038 | China |
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| The First Hospital of Jilin University | Recruiting | Changchun | Jilin | 130021 | China |
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| Jilin Province FAW General Hospital | Recruiting | Changchun | Jilin | 130051 | China |
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| Affilated Zhongshan Hospital of Dalian University | Recruiting | Dalian | Liaoning | 116001 | China |
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| Frist Aiffiliated Hospital of Dalian Medical University | Recruiting | Dalian | Liaoning | 116011 | China |
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| The second hospital of Dalian Medical University | Recruiting | Dalian | Liaoning | 116027 | China |
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| Inner Mongolia Xing'an League People's Hospital | Recruiting | Ulanhot | Neimenggu | 137400 | China |
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| The First People's Hospital of Yinchuan | Recruiting | Yinchuan | Ningxia | 750000 | China |
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| Qinghai Province Cardiovascular and Cerebrovascular Disease Specialist Hospital | Recruiting | Xining | Qinghai | 810000 | China |
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| Qinghai University Affiliated Hospital | Recruiting | Xining | Qinghai | 810001 | China |
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| the Second Hospital, Cheeloo College of Medicine, Shandong University | Recruiting | Jinan | Shandong | 250000 | China |
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| Qilu Hospital of Shandong University | Recruiting | Jinan | Shandong | 250012 | China |
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| Central Hospital Affiliated to Shandong First Medical University | Recruiting | Jinan | Shandong | 250013 | China |
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| People's Hospital of Donga County, Shandong Province | Recruiting | Liaocheng | Shandong | 252200 | China |
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| Qingdao Hospital University of Health and Rehabilitation Sciences (Qingdao Municipal Hospital) | Recruiting | Qingdao | Shandong | 266000 | China |
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| Shanghai Institute of Hypertension, Ruijin Hospital, Shanghai Jiaotong University School of Medicine | Recruiting | Shanghai | Shanghai Municipality | 200025 | China |
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| Shanghai Putuo District Central Hospital | Recruiting | Shanghai | Shanghai Municipality | 200062 | China |
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| Shanghai General Hospital ( originally named Shanghai First People's Hospital), Shanghai Jiao Tong University School of Medicine | Recruiting | Shanghai | Shanghai Municipality | 200080 | China |
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| the second hospital of ShanXi medical unversity | Recruiting | Taiyuan | Shanxi | 030001 | China |
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| Xi'an People's Hospital | Recruiting | Xi’an | Shanxi | 710018 | China |
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| The Affiliated Hospital of Southwest Jiaotong University, The Third People's Hospital of Chengdu, Chengdu, China | Recruiting | Chengdu | Sichuan | 610031 | China |
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| The First Affiliated Hospital of Chengdu Medical College | Recruiting | Chengdu | Sichuan | 610500 | China |
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| Chengdu Fifth People's Hospital | Recruiting | Chengdu | Sichuan | 611130 | China |
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| Tianjin Medical University General Hospital | Recruiting | Tianjin | Tianjin Municipality | 300052 | China |
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| The Second Hospital of Tianjin Medical University | Recruiting | Tianjin | Tianjin Municipality | 300211 | China |
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| TEDA International Cardiovascular Hospital | Recruiting | Tianjin | Tianjin Municipality | 300457 | China |
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| Changdu People's Hospital of Tibet | Recruiting | Chamdo | Tibet | 854000 | China |
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| Xinjiang Uygur Autonomous Region People's Hospital | Recruiting | Ürümqi | Xinjiang | 830001 | China |
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| Yili Kazak Autonomous Prefecture Friendship Hospital | Recruiting | Yining | Xinjiang | 835000 | China |
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| The First Affiliated Hospital of Kunming Medical University | Recruiting | Kunming | Yunnan | 650031 | China |
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| Yan'an Affiliated Hospital of Kunming Medical University | Recruiting | Kunming | Yunnan | 650051 | China |
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| Fuwai Yunnan Cardiovascular Hospital | Recruiting | Kunming | Yunnan | 650102 | China |
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| Zhejiang Hospital | Recruiting | Hangzhou | Zhejiang | 310000 | China |
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| ID | Term |
|---|---|
| D006929 | Hyperaldosteronism |
| ID | Term |
|---|---|
| D000308 | Adrenocortical Hyperfunction |
| D000307 | Adrenal Gland Diseases |
| D004700 | Endocrine System Diseases |
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