HyperaldosteronismCHAMPIONNCT07252284
CHina Adrenal Venous saMPling InvestigatiON
An observational study of Hyperaldosteronism and Adrenal Venous Sampling, run by Chinese Academy of Medical Sciences, Fuwai Hospital at 76 sites in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hyperaldosteronism, Adrenal Venous Sampling, Adrenalectomy
- What is being tested?
- adrenal venous sampling
- Type of treatment
- Surgery or procedure
- How many people
- 5,000 participants
- Where
- 76 sitesChina
- Study dates
- 1 May 2025to 31 Aug 2029
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients with confirmed primary aldosteronism underwent adrenal venous sampling.
Who may be able to join
- Patients with confirmed primary aldosteronism;
- Patients undergoing adrenal venous sampling for subtype classification of primary aldosteronism.
Who cannot join
- Severe comorbidity, including stroke, myocardial infarction, heart failure, severe valvular heart disease, liver cirrhosis, and metastatic tumor within the previous 3 months;
- An estimated glomerular filtration rate <45 ml/min/1.73 m2, or serum creatinine >176 μmol/L;
- Patients who refuse adrenalectomy;
- Suspected of having an adrenocortical carcinoma;
- Allergy to contrast agent;
- Pregnant, nursing, or planning to become pregnant
Trial locations and contacts
76 sites in 1 country. Contact the study team or a site near you to ask about taking part.
76 sites in 1 country
China76 sites, 76 recruiting
- Recruiting
Chuiyangliu Hospital affiliated to Tsinghua University
Beijing, Beijing Municipality, 100022
Lin Pi, MD, 010-87766377, pilindoctor@126.com
Lin Pi, MD
- Recruiting
China-Japan Friendship Hospital
Beijing, Beijing Municipality, 100029
Wuqiang Che, MD, 010-84205136, chemokel@163.com
Wuqiang Che, MD
- Recruiting
Peking University First Hospital
Beijing, Beijing Municipality, 100034
Wei Ma, MD, 13681050902, kmmawei@sina.com
Wei Ma, MD
- Recruiting
Fuwai Hospital, National Center for Cardiovascular Disease, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, Beijing Municipality, 100037
Hui Dong, MD, 86-010-88322385, donghui666@sina.com
Xiongjing Jiang, MD, 86-010-88322387, jiangxiongjing@163.com
- Recruiting
Peking University People's Hospital
Beijing, Beijing Municipality, 100044
Jing Liu, MD, 010-66583710, heartcenter@163.com
Jing Liu, MD
- Recruiting
Beijing Luhe Hospital, Capital Medical University
Beijing, Beijing Municipality, 101100
Dong Zhao, MD, PhD, 010-69543901, zhaodong@ccmu.edu.cn
Dong Zhao, MD, PhD
- Recruiting
Changdu People's Hospital of Tibet
Chamdo, Tibet, 854000
Rui Xiang, MD, 0895-4821745
Rui Xiang, MD
- Recruiting
The First Hospital of Jilin University
Changchun, Jilin, 130021
Wei Zhao, MD, 0431-88782342, w_zhao@jlu.edu.cn
Wei Zhao, MD
- Recruiting
Jilin Province FAW General Hospital
Changchun, Jilin, 130051
Wenhai Wang, MM, 043185904542, 767732002@qq.com
Wenhai Wang, MM
- Recruiting
The Affiliated Hospital of Southwest Jiaotong University, The Third People's Hospital of Chengdu, Chengdu, China
Chengdu, Sichuan, 610031
Zhen Zhang, MD, 13708042927, 31350377@qq.com
Zhen Zhang, MD
- Recruiting
The First Affiliated Hospital of Chengdu Medical College
Chengdu, Sichuan, 610500
Peijian Wang, MD, 18980718263, wpjmed@aliyun.com
Peijian Wang, MD
- Recruiting
Chengdu Fifth People's Hospital
Chengdu, Sichuan, 611130
Mingjian Lang, (028) 8271 0681, zcl628@163.com
Mingjian Lang, MD
- Recruiting
Chongqing University Central Hospital
Chongqing, Chongqing Municipality, 400000
Dongying Zhang, MD, 13608398395, zhangdongying@cqmu.edu.cn
Dongying Zhang, MD
- Recruiting
Chongqing General Hospital
Chongqing, Chongqing Municipality, 401147
Rui He, MM, 023-63390560, 253942231@qq.com
Rui He, MM
- Recruiting
People's Hospital Affiliated to ChongqingThree Gorges Medical college
Chongqing, Chongqing Municipality, 404100
Xianhu Luo, MD, 15923433929, 826863635@qq.com
Xianhu Luo, MD
- Recruiting
Affilated Zhongshan Hospital of Dalian University
Dalian, Liaoning, 116001
Minglian Gong, MD, 0411-62896223, gongml777@126.com
Minglian Gong, MD
- Recruiting
Frist Aiffiliated Hospital of Dalian Medical University
Dalian, Liaoning, 116011
Yinong Jiang, MD, 0411-83635963, yinongjiang@163.com
Yinong Jiang, MD
- Recruiting
The second hospital of Dalian Medical University
Dalian, Liaoning, 116027
Nan Niu, MD, 17709875885, nn_6581@aliyun.com
Nan Niu, MD
- Recruiting
The Forth People's Hosptal of Nanhai District of Foshan City
Foshan, Guangdong, 528211
Yayan Han, MD, 0757-86866918, hyy321521@sohu.com
Yayan Han, MD
- Recruiting
First Affiliated Hospital, Fujian Medical University, Fuzhou, China,
Fuzhou, Fujian, 0591-87982222
Feng Peng, MD, 0591-87982222, pengfeng@fjmu.edu.cn
Feng Peng, MD
- Recruiting
The First Affiliated Hospital of Gannan Medical University
Ganzhou, Jiangxi, 341000
Jiayuan Ling, MD, 18807972012, 15803152@qq.com
Jiayuan Yuan, MD
- Recruiting
Guangdong Provincial People's Hospital (Guangdong Academy of Medical Sciences)
Guangzhou, Guangdong, 510080
Yingqing Feng, MD, 13602863389, fyq1819@163.com
Yingqing Feng, MD
- Recruiting
Guizhou Provincial People's Hospital, Guiyang, Guizhou 550002, China.
Guiyang, Guizhou, 550002
Fang Song, MD, 18685191199, songfangheart@126.com
Fang Song, MD
- Recruiting
The Affiliated Hospital of Guizhou Medical University
Guiyang, Guizhou, 550004
Zhangrong Chen, MD, 0856-88689263, chenzhangrong71@163.com
Zhangrong Chen, MD
- Recruiting
Hainan General Hospital, Department of Endocrinology
Haikou, Hainan, 570311
Haiyu Zhang, MM, 0898-68622221, yuhai_2013@163.com
Haiyu Zhang, MM
- Recruiting
Hainan General Hospital, Department of Cardiology
Hainan, Hainan, 570311
Wang Liao, MD, 13518827831, crain_lw@163.com
Wang Liao, MD
- Recruiting
Zhejiang Hospital
Hangzhou, Zhejiang, 310000
Yimin Tang, MD, 13758176000, tang5995@aliyun.com
Yimin Tang, MD
- Recruiting
The First Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, 150001
Dechao Zhao, MD, 0451-85555723, drzhaodechao@163.com
Dechao Zhao, MD
- Recruiting
The Second Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, 150086
Shuo Zhang, MD, 18645056661, zhangshuoemail@163.com
Shuo Zhang, MD
- Recruiting
The first affiliated hospital of USTC
Hefei, Anhui, 230036
Xiangyong Kong, PhD, 0551-62284055, kxyong1234@163.com
Xiangyong Kong, PhD
- Recruiting
the Second Hospital, Cheeloo College of Medicine, Shandong University
Jinan, Shandong, 250000
Qinghai Wang, MD, 0543-85875088, sdwqh1005@126.com
Qinghai Wang, MD
- Recruiting
Qilu Hospital of Shandong University
Jinan, Shandong, 250012
Peili Bu, MD, 18560086596, bupeili@medmail.com.cn
Peili Bu, MD
- Recruiting
Central Hospital Affiliated to Shandong First Medical University
Jinan, Shandong, 250013
Rui Xu, MD, PhD, 0531-88653212, xuruicn@hotmail.com
Rui Xu, MD, PhD
- Recruiting
Kai Feng the Peoples Hospital
Kaifeng, Henan, 475002
Qingli Pan, MD, 0371-22730719, 742642136@qq.com
Qingli Pan, MD
- Recruiting
The Second Affiliated Hospital Of Guizhou Medical University
Kaili, Guizhou, 556000
Yumei Xiang, MD, 0855-3833103, 1016313267@qq.com
Yumei Xiang, MD
- Recruiting
The First Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, 650031
Lihua Zhang, PhD, 0871-65324888-6133, lihuazhang772002@163.com
Lihua Zhang, PhD
- Recruiting
Yan'an Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, 650051
Yan He, MD, 0871-63211375, 1349561462@qq.com
Yan He, MD
- Recruiting
Fuwai Yunnan Cardiovascular Hospital
Kunming, Yunnan, 650102
Zihong Guo, MD, 0871-68515973, guozihong1962@163.com
Zihong Guo, MD
- Recruiting
Lanzhou University Second Hospital
Lanzhou, Gansu, 730000
Wei Liang, MD, 0931-5190690, 758099072@qq.com
Wei Liang, MD
- Recruiting
People's Hospital of Donga County, Shandong Province
Liaocheng, Shandong, 252200
Xiaoli Wang, MD, 15865751121, w15865751121@126.com
Xiaoli Wang, MD
- Recruiting
Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330006
Yifei Dong, MD, PhD, 0791-8735-7354, yf_dong66@126.com
Yifei Dong, MD, PhD
- Recruiting
Jiangxi Provincial People's Hospital (The First Affiliated Hospital of Nanchang Medical College)
Nanchang, Jiangxi, 330038
Haohang Ruan, MBBS, 0791-87721036
Haohang Ruan, MBBS
- Recruiting
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, 530000
Jiangnan Huang, MD, 07715359553, huangjn1998@163.com
Jiangnan Huang, MD
- Recruiting
The Second Affliated Hospital Of GuangXi Medical Univesity
Nanning, Guangxi, 530007
Houfa Ning, MM, 0771-3277215, houfa.ning@foxmail.com
Houfa Ning, MM
- Recruiting
Nanning Third People's Hospital
Nanning, Guangxi, 547000
Yongqi Xiao, MBBS, 07713394390
Yongqi Xiao, MBBS
- Recruiting
Qingdao Hospital University of Health and Rehabilitation Sciences (Qingdao Municipal Hospital)
Qingdao, Shandong, 266000
Nan Jia, MD, 17669783012, jiananchina@qq.com
Nan Jia, MD
- Recruiting
Shanghai Institute of Hypertension, Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, 200025
Jiangzhong Xu, MD, PhD, 13761452329, jianzhongxv@outlook.com
Jianzhong Xu, MD, PhD
- Recruiting
Shanghai Putuo District Central Hospital
Shanghai, Shanghai Municipality, 200062
Zongjun Liu, MD, 021-22233222, liuzongjun1548@shutcm.edu.cn
Zongjun Liu, MD
- Recruiting
Shanghai General Hospital ( originally named Shanghai First People's Hospital), Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200080
Zhi Zhang, MD, 13621759762, 16683890@qq.com
Zhi Zhang, MD
- Recruiting
Fuwai Hospital Chinese Academy of Medical Sciences, Shenzhen
Shenzhen, Guangdong, 518000
Jianqiong Kong, MD, 13510568376, 2653290915@qq.com
Jianqiong Kong, MD
- Recruiting
Shenzhen Third People's Hospital,Shenzhen, Guangdong Province 518112, China
Shenzhen, Guangdong, 518112
Zhenzhong Zheng, MD, PhD, 0755-61222333, greateful@163.com
Zhenzhong Zheng, MD, PhD
- Recruiting
Shenzhen Dapeng New District Kuiyong People's Hospital
Shenzhen, Guangdong, 518116
Tongqing Lu, MD, 0755-84204067, lutongqing@hotmail.com
Tongqing Lu, MD
- Recruiting
the second hospital of ShanXi medical unversity
Taiyuan, Shanxi, 030001
Bin Yang, MD, 13546355355, yangbxys@163.com
Bin Yang, MD
- Recruiting
Tangshan hongci Hospital
Tangshan, Hebei, 063000
Guijuan Zhang, MD, 0315-6272993, zhangguijun1212@63.com
Guijuan Zhang, MD
- Recruiting
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, 300052
Dianxun Fu, MD, 022-60814078, cmufudx1@126.com
Dianxun Fu, MD
- Recruiting
The Second Hospital of Tianjin Medical University
Tianjin, Tianjin Municipality, 300211
Changle Liu, MD, 15522133881, lcl1979_2001@163.com
Changle Liu, MD
- Recruiting
TEDA International Cardiovascular Hospital
Tianjin, Tianjin Municipality, 300457
Weiqiang Chen, MM, 022-65209995, 13821205212@163.com
Weiqiang Wang, MM
- Recruiting
Inner Mongolia Xing'an League People's Hospital
Ulanhot, Neimenggu, 137400
Tao Guo, MM, 0482-8282080, guot18@lzu.edu.cn
Tao Guo, MM
- Recruiting
Xinjiang Uygur Autonomous Region People's Hospital
Ürümqi, Xinjiang, 830001
Guoliang Wang, PhD, 0991-8563065, 908022751@qq.com
Guoliang Wang, PhD
- Recruiting
Renmin Hospital of Wuhan University
Wuhan, Hubei, 430060
Hongxin Xu, MD, 18908640597, 303876340@qq.com
Hongxin Xu, MD
- Recruiting
Xi'an People's Hospital
Xi’an, Shanxi, 710018
Kang Cheng, MD, PhD, 029-61199240, chengkang75@126.com
Kang Cheng, MD, PhD
- Recruiting
Cardiovascular Hospital Xiamen University
Xiamen, Fujian, 361016
Tao Ye, MD, 029-2292337, yetao@xmu.edu.cn
Tao Ye, MD
- Recruiting
Xiangyang Central Hospital, Affiliated Hospital of Hubei University of Arts and Science
Xiangyang, Hubei, 441021
Qingan Li, MD, 0710-2811051, 2145439882@qq.com
Qingan Li, MD
- Recruiting
Qinghai Province Cardiovascular and Cerebrovascular Disease Specialist Hospital
Xining, Qinghai, 810000
Xiaozhou Wang, MD, 0971-6288407, wxz_1978@163.com
Xiaozhou Wang, MD
- Recruiting
Qinghai University Affiliated Hospital
Xining, Qinghai, 810001
Ming Ren, MM, 13709788862, qhrm-0971@163.com
Ming Ren, MM
- Recruiting
Xuzhou Central Hospital, Jiangsu
Xuzhou, Jiangsu, 221009
Hongyun Ruan, MD, 0516-83985031, hongyunruan@163.com
Hongyun Ruan, MD
- Recruiting
Yichang Central People's Hospital
Yichang, Hubei, 43000
Yunbo Lv, MD, 0717-6229791, 362435582@qq.com
Yunbo Lv, MD
- Recruiting
The First People's Hospital of Yinchuan
Yinchuan, Ningxia, 750000
Fang Chen, PhD, 13895008699, cf720302@126.com
Fang Chen, PhD
- Recruiting
Yili Kazak Autonomous Prefecture Friendship Hospital
Yining, Xinjiang, 835000
Wei Li, MBBS, 18935778517, 18935778517@163.com
Wei Li, MBBS
- Recruiting
Fuwai Central China Cardiovascular Hospital
Zhengzhou, Henan, 450000
Qiuping Zhao, PhD, 0371-58681170, qiupingzhao@zzu.edu.cn
Qiuping Zhao, PhD
- Recruiting
Henan Provincial People's Hospital
Zhengzhou, Henan, 450003
Min Liu, MD, 0371-65586642, liumin136@126.com
Min Liu, MD
- Recruiting
Zhengzhou Central Hospital Affiliated to Zhengzhou University
Zhengzhou, Henan, 450007
Shuhua Yu, MM, 0371-67690941, 13613716677@139.com
Shuhua Yu, MM
- Recruiting
Zhengzhou Yihe Hospital
Zhengzhou, Henan, 450018
Liang An, MD, 0371-56570913, 184530063@qq.com
Liang An, MD
- Recruiting
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052
Youyou Du, MD, 0371-67966613, duyouyou_008@163.com
Youyou Du, MD
- Recruiting
Zhoukou Central Hospital
Zhoukou, Henan, 466000
Baogong Wang, MD, 0394-8521613, 598634874@qq.com
Baogong Wang, MD
- Recruiting
Zhuzhou Hospital Affiliated to Xiangya School of Medicine,Central South University
Zhuzhou, Hunan, 412000
Liang Tang, MBBS, 0733-28561703
Liang Tang, MBBS
About this study
Official title: China Adrenal Venous Sampling Investigation: A National Multicenter Study
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.
Read the detailed description
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.
- Conditions
- Hyperaldosteronism, Adrenal Venous Sampling, Adrenalectomy
- Being tested
- adrenal venous sampling
- Keywords
- Adrenal venous sampling, Hyperaldosteronism, Antecubital approach, Femoral approach, Main adverse cardiovascular events
- Medical subject headings
- Hyperaldosteronism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
adrenal venous samplingProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: adrenal venous sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year after AVS procedure
Secondary outcomes (20)
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)
Measured: At AVS procedure
The success rate of right 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)
Measured: 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)
Measured: At AVS procedure
Selection of intraoperative catheter
Types of catheter at the time of Adrenal Venous Sampling via antecubital approach or femoral approach
Measured: At AVS procedure
Time of the procedure
Time of the procedure
Measured: At AVS procedure
Time of fluoroscopy
Time of fluoroscopy
Measured: At AVS procedure
The contrast agent dosage
The contrast agent dosage
Measured: At AVS procedure
the incidence of complications
Complications related to adrenal vein cannulations (adrenal vein hematoma, inferior vena cava dissection, puncture site hematoma, etc)
Measured: 1 week after AVS procedure
the cost of the procedure
the cost of the procedure
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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。
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At 6 and 18 months; and 2, 3, 4, 5, and 10 years after AVS procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2025
- Study start1 May 2025
- Primary completion31 Aug 2029 (estimated)
- Study completion31 Aug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperaldosteronismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 5,000 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Chinese Academy of Medical Sciences, Fuwai Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hui DONG, Chinese Academy of Medical Sciences, Fuwai Hospital
- Investigators
- Hui Dong, MD, Principal investigator, Fuwai Hospital, National Center for Cardiovascular Disease, Chinese Academy of Medical Sciences and Peking Union Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07252284
- Sponsor's protocol ID
- 2024-2484
- Acronym
- CHAMPION
- Status last verified
- Nov 2025
- First submitted
- 19 Nov 2025
- Last updated
- 26 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- China Adrenal Venous Sampling Investigation: A National Multicenter Study
- ClinicalTrials.gov ID
- NCT07252284
- Acronym / sponsor ID
- CHAMPION / 2024-2484
- Conditions
- Hyperaldosteronism, Adrenal Venous Sampling, Adrenalectomy
- Keywords
- Adrenal venous sampling, Hyperaldosteronism, Antecubital approach, Femoral approach, Main adverse cardiovascular events
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Chinese Academy of Medical Sciences, Fuwai HospitalUniversity, hospital or other
- Study start
- 1 May 2025 (actual)
- Primary completion
- 31 Aug 2029 (estimated)
- Study completion
- 31 Aug 2029 (estimated)
- First posted
- 26 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adrenal Venous Sampling | – | Procedure: adrenal venous samplingPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients with confirmed primary aldosteronism underwent adrenal venous sampling.
Key inclusion criteria (2 listed)
- Patients with confirmed primary aldosteronism;
- Patients undergoing adrenal venous sampling for subtype classification of primary aldosteronism.
Key exclusion criteria (6 listed)
- Severe comorbidity, including stroke, myocardial infarction, heart failure, severe valvular heart disease, liver cirrhosis, and metastatic tumor within the previous 3 months;
- An estimated glomerular filtration rate <45 ml/min/1.73 m2, or serum creatinine >176 μmol/L;
- Patients who refuse adrenalectomy;
- Suspected of having an adrenocortical carcinoma;
- Allergy to contrast agent;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| adrenal venous samplingPatients 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. | Procedure or surgery | Adrenal Venous Sampling |
Primary outcome
Major adverse cardiovascular events (MACE) at 1-year follow-up
Time frame: 1 year after AVS procedure
Incidence of major adverse cardiovascular events (MACE) at 1-year follow-up, including stroke, heart failure, severe arrhythmias, renal failure, myocardial infarction, and death.
20 secondary outcomes
The success rate of left adrenal venous sampling
Time frame: At AVS procedure
The success rate of right adrenal venous sampling
Time frame: At AVS procedure
The success rate of bilateral adrenal venous sampling
Time frame: At AVS procedure
Selection of intraoperative catheter
Time frame: At AVS procedure
Time of the procedure
Time frame: At AVS procedure
Time of fluoroscopy
Time frame: At AVS procedure
The contrast agent dosage
Time frame: At AVS procedure
the incidence of complications
Time frame: 1 week after AVS procedure
the cost of the procedure
Time frame: At AVS procedure
Change in 24-hour ambulatory systolic blood pressure
Time frame: 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
Time frame: At 1, 3, 6, 12, and 18 months; and 2, 3, 4, 5, and 10 years after treatment
Change in office systolic blood pressure
Time frame: At 1, 3, 6, 12, and 18 months; and 2, 3, 4, 5, and 10 years after treatment
Change in office diastolic blood pressure
Time frame: At 1, 3, 6, 12, and 18 months; and 2, 3, 4, 5, and 10 years after treatment
Change in antihypertensive medication burden
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: At 6, 12, and 18 months; and 2, 3, 4, 5, and 10 years after surgery
Major adverse cardiovascular events (MACE)
Time frame: At 6 and 18 months; and 2, 3, 4, 5, and 10 years after AVS procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hui Dong, MD principal investigator
Fuwai Hospital, National Center for Cardiovascular Disease, Chinese Academy of Medical Sciences and Peking Union Medical College
76 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hyperaldosteronism and Adrenal Venous Sampling, run by Chinese Academy of Medical Sciences, Fuwai Hospital at 76 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 76 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hui Dong, MD (86-010-88322385, donghui666@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major adverse cardiovascular events (MACE) at 1-year follow-up (time frame: 1 year after AVS procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2025.