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HyperaldosteronismCNAVSNCT06192238

China National Study of Adrenal Venous Sampling

An observational study of Hyperaldosteronism, run by Chinese Academy of Medical Sciences, Fuwai Hospital at 48 sites in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

This multicenter study intends to combine retrospective analysis and prospective registry to evaluate the success rate and safety of adrenal venous sampling (AVS) via antecubital and femoral approach for patients with primary aldosteronism. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Hyperaldosteronism
What is being tested?
adrenal venous sampling
Type of treatment
Surgery or procedure
How many people
1,500 participants
Where
48 sitesChina
Study dates
1 Jan 2024to 30 Dec 2026
How long will I take part?
3 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 to 65 years
  • All sexes
  • Adult, Older adult

Study population: Patients with confirmed primary aldosteronism aged from 18 to 65 with no limits in sex

Who may be able to join

  • Aged from 18 to 65 with no limits in sex;
  • Patients with confirmed primary aldosteronism;
  • Patients or their legal representatives sign written informed consent approved by the ethics committee;

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

48 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Xiongjing Jiang, MD contact

86-010-88322387

jxj103@hotmail.com

48 sites in 1 country

China48 sites
  • Chuiyangliu Hospital affiliated to Tsinghua University

    Beijing, Beijing Municipality, 100022

    Lin Pi, MD, 86-010-87766377, pilindoctor@126.com

    Lei Gao, doctorgaolei@foxmail.com

  • China-Japan Friendship Hospital

    Beijing, Beijing Municipality, 100029

    Wuqiang Che, MD, 86-010-84205136, chemokel@163.com

    Wuqiang Che, MD

  • Peking University First Hospital

    Beijing, Beijing Municipality, 100034

    Wei Ma, MD, kmmawei@sina.com

    Tieci Yi, ytc_bjmu@126.com

  • Fuwai Hospital, National Center for Cardiovascular Disease, Chinese Academy of Medical Sciences and Peking Union Medical College

    Beijing, Beijing Municipality, 100037

    Xiongjing Jiang, MD, 86-010-88322387, jiangxiongjing@163.com

    Hui Dong, MD, 86-10-88322385, donghui666@sina.com

  • Beijing Luhe Hospital, Capital Medical University

    Beijing, Beijing Municipality, 101100

    Dong Zhao, MD,PHD, 86-010-69543901, zhaodong@ccmu.edu.cn

    Bin Cao, dor_caobin666@163.com

  • Jilin Province FAW General ospital

    Changchun, Jilin, 130051

    Wenhai Wang, MM, 86-0431-85904542, 767732002@qq.com

    Wenhai Wang, MM

  • The Affiliated Hospital of Southwest Jiaotong University, The Third People's Hospital of Chengdu, Chengdu, China

    Chengdu, Sichuan, 610031

    Zhen Zhang, MD, 31350377@qq.com

    Hui Jiang, 542392559@qq.com

  • The First Affiliated Hospital of Chengdu Medical College

    Chengdu, Sichuan, 610500

    Peijian Wang, MD, wpjmed@aliyun.com

    Xinquan Wang, 213474962@qq.com

  • Chengdu Fifth People's Hospital

    Chengdu, Sichuan, 611130

    Mingjian Lang, MD, 86-028-82710681, zcl628@163.com

    Congliang Zhou

  • The First Affiliated Hospital of Chongqing Medical University

    Chongqing, Chongqing Municipality, 400000

    Dongying Zhang, MD, zhangdongying@cqmu.edu.cn

    Lei Gao, gl@cqmu.edu.cn

  • Chongqing General Hospital

    Chongqing, Chongqing Municipality, 401147

    Rui He, MM, 86-023-63390560, 253942231@qq.com

    Fangchao Wang, 253942231@qq.com

  • People's Hospital Affiliated to ChongqingThree Gorges Medical college

    Chongqing, Chongqing Municipality, 404100

    Xianhu Luo, MD, 826863635@qq.com

    Xianhu Luo, MD

  • Frist Aiffiliated Hospital of Dalian Medical University

    Dalian, Liaoning, 116011

    Yinong Jiang, MD, 86-0411-83635963, yinongjiang@163.com

    Ying Zhang, zy114129@sina.com

  • The Forth People's Hosptal of Nanhai District of Foshan City

    Foshan, Guangdong, 528211

    Yayan Han, MD, 86-0757-86866918, hyy321521@sohu.com

    Yayan Han, MD

  • Guangdong Provincial People's Hospital (Guangdong Academy of Medical Sciences)

    Guangzhou, Guangdong, 510080

    Yingqing Feng, MD, fyq1819@163.com

    Songyuan Luo, water6459531@foxmail.com

  • Zhejiang Hospital

    Hangzhou, Zhejiang, 310000

    Yimin Tang, MD, tang5995@aliyun.com

    Yingzheng Weng, wyz1101140217@163.com

  • The First Affiliated Hospital of Harbin Medical University

    Harbin, Heilongjiang, 150001

    Dechao Zhao, MD, 86-0451-85555723, drzhaodechao@163.com

    Chunnan Liu, 416058320@qq.com

  • Qilu Hospital of Shandong University

    Jinan, Shandong, 250012

    Peili Bu, MD, bupeili@medmail.com.cn

    Yun Ti, tiyun0820@163.com

  • Central Hospital Affiliated to Shandong First Medical University

    Jinan, Shandong, 250013

    Rui Xu, MD &. PhD, 86-0531-88653212, xuruicn@hotmail.com

    Lin Wang, wanglin54202003@163.com

  • The Second Affiliated Hospital Of Guizhou Medical University

    Kaili, Guizhou, 556000

    Yumei Xiang, MD, 86-0855-3833103, 1016313267@qq.com

    Jing Zhang, 183515314@qq.com

  • Fuwai Yunnan Cardiovascular Hospital

    Kunming, Yunnan, 650102

    Zihong Guo, Bachelor, 86-0871-68515973, guozihong1962@163.com

    Yajing Zhao, zhaoyajing@kmmu.edu.cn

  • Lanzhou University Second Hospital

    Lanzhou, Gansu, 730000

    Wei Liang, MD, 86-0931-5190690, 758099072@qq.com

    Heng Yu

  • People's Hospital of Donga County, Shandong Province

    Liaocheng, Shandong, 252200

    Xiaoli Wang, MD, w15865751121@126.com

    Huaiting Ren, rht-yt@163.com

  • Second Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi, 330006

    Yifei Dong, MD,PhD, 86-0791-8735-7354, yf_dong66@126.com

    Hongliang Xiong, xhlcmu@163.com

  • Jiangxi Provincial People's Hospital (The First Affiliated Hospital of Nanchang Medical College)

    Nanchang, Jiangxi, 330038

    Haohang Ruan, MBBS, 86-0791-87721036

    Zhihong Dai, daizhihong319@163.com

  • The First Affiliated Hospital of Guangxi Medical University

    Nanning, Guangxi, 530000

    Jiangnan Huang, MD, 86-07715359553, huangjn1998@163.com

    Jianling LI

  • Nanning Third People's Hospital

    Nanning, Guangxi, 547000

    Yongqi Xiao, MS, 86-07713394390

    Xuenuo Wu, 515655344@qq.com

  • Shanghai Institute of Hypertension, Ruijin Hospital, Shanghai Jiaotong University School of Medicine

    Shanghai, Shanghai Municipality, 200025

    Jianzhong Xu, MD,PhD, jianzhongxv@outlook.com

    Yuanyuan Kang, kangyuanyuan@163.com

  • Shanghai Putuo District Central Hospital

    Shanghai, Shanghai Municipality, 200062

    Zongjun Liu, MD, 86-021-22233222, liuzongjun1548@shutcm.edu.cn

    Junqing Gao

  • Shenzhen Third People's Hospital,Shenzhen, Guangdong Province 518112, China

    Shenzhen, Guangdong, 518112

    Zhenzhong Zheng, MD,PHD, 86-0755-61222333, greateful@163.com

    Zhenzhong Zheng, MD,PHD

  • Shenzhen Dapeng New District Kuiyong People's Hospital

    Shenzhen, Guangdong, 518116

    Tongqing Lu, MD, 86-0755-84204067, lutongqing@hotmail.com

    Xianglin Wang, 1010720607@qq.com

  • The second hospital of Shanxi medical unversity

    Taiyuan, Shanxi, 030001

    Bin Yang, MD, yangbxys@163.com

    Huili Cao, xdzhang7946@163.com

  • Tangshan hongci Hospital

    Tangshan, Hebei, 063000

    Guijuan Zhang, MD, 86-0315-6272993, zhangguijun1212@63.com

    Guoyan Zhang, 13472986773@139.con

  • Tianjin Medical University General Hospital,

    Tianjin, Tianjin Municipality, 300052

    Dianxun Fu, MD, 86-022-60814078, cmufudx1@126.com

    Boyu Liu, whisper_liu@163.com

  • The Second Hospital of Tianjin Medical University

    Tianjin, Tianjin Municipality, 300211

    Changle Liu, MD, lcl1979_2001@163.com

    Yuanyuan Wang, wangyy3819@126.com

  • TEDA International Cardiovascular Hospital

    Tianjin, Tianjin Municipality, 300457

    Weiqiang Chen, MM, 86-022-65209995, 13821205212@163.com

    Weiqiang Chen, MM

  • Xi'an People's Hospital

    Xi'an, Shaanxi, 710018

    Kang Cheng, MD&PhD, 86-029-61199240, chengkang75@126.com

    Xiangrong Gong, qyz1271922954@163.com

  • Cardiovascular Hospital Xiamen University

    Xiamen, Fujian, 361016

    Tao Ye, MD, 86-029-2292337, yetao@xmu.edu.cn

    Jingzhou Li, storm7993@126.com

  • Xiangyang Central Hospital, Affiliated Hospital of Hubei University of Arts and Science

    Xiangyang, Hubei, 441021

    Qing'an Li, 86-0710-2811051, 2145439882@qq.com

    Luhong Li

  • Qinghai Province Cardiovascular and Cerebrovascular Disease Specialist Hospital

    Xining, Qinghai, 810000

    Xiaozhou Wang, 86-0971-6288407, wxz_1978@163.com

    Zhanqing Ma, 86-0971-6288407, 67099363@qq.com

  • Yichang Central People's Hospital

    Yichang, Hubei, 443000

    Yunbo Lv, MD, 86-0717-6229791, 362435582@qq.com

    Ling Fang, 417867518@qq.com

  • Yili Kazak Autonomous Prefecture Friendship Hospital

    Yili Kazak Autonomous Prefecture, Xinjiang, 835000

    Wei Li, MB, 18935778517@163.com

    Gangqiang Zhang, 2060635767@qq.com

  • The First People's Hospital of Yinchuan

    Yinchuan, Ningxia, 750000

    Fang Chen, PD, cf720302@126.com

    Yunhai Ma

  • Fuwai Central China Cardiovascular Hospital

    Zhengzhou, Henan, 450000

    Qiuping Zhao, PhD, 86-0371-58681170, qiupingzhao@zzu.edu.cn

    Minfu Bai, baiminfu@126.com

  • Henan Provincial People's Hospital

    Zhengzhou, Henan, 450003

    Min Liu, MD, 86-0371-65586642, liumin136@126.com

    Xiaojian Zhao, 2120251@qq.com

  • Zhengzhou Central Hospital Affiliated to Zhengzhou University

    Zhengzhou, Henan, 450007

    Shuhua Yu, MM, 86-0371-67690941, 13613716677@139.com

    Xiaobin Zhao, zhaoxiaobin2019@126.com

  • Zhengzhou Yihe Hospital

    Zhengzhou, Henan, 450018

    Liang An, BD, 86-0371-56570913, 184530063@qq.com

    Wenquan Zhou, 1033572271@qq.com

  • Zhoukou Central Hospital

    Zhoukou, Henan, 466000

    Baogong Wang, MD, 86-0394-8521613, 598634874@qq.com

    Yonghua Song, roar06@163.com

Other trials in China

About this study

Official title: A National Multicenter Study of Adrenal Venous Sampling for the Subtype Diagnosis of Primary Aldosteronism in China

This multicenter study intends to combine retrospective analysis and prospective registry to evaluate the success rate and safety of adrenal venous sampling (AVS) via antecubital and femoral approach for patients with primary aldosteronism. The consistency of AVS with pathological results and clinical outcomes, the factors affecting the success of AVS, and the optimal population for AVS will be aslo analyzed in this study.

Read the detailed description

Primary aldosteronism (PA) is one of the most common causes of secondary hypertension, and its most common subtypes are aldosterone-producing adenoma and idiopathic hyperaldosteronism, which account for 95% to 98% of PA. Subtype diagnosis is crucial for the treatment of primary aldosteronism, which conducts the appropriate treatment strategy. Currently, adrenal venous sampling (AVS) serves as the gold standard for subtyping of PA. How to improve the success rate of AVS has been a hot topic in the field of primary aldosteronism. This multicenter registry study intends to combine retrospective analysis and prospective registry to evaluate the success rate and safety of AVS via antecubital and femoral approach for patients with primary aldosteronism. The consistency of AVS with pathological results and clinical outcomes, the factors affecting the success of AVS, and the optimal population for AVS will be also analyzed in this study.

Being tested
adrenal venous sampling
Keywords
Adrenal venous sampling, Hyperaldosteronism, Antecubital approach, Femoral approach, Pathological results
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 groups in NCT06192238
Study groupRoleWhat they receive
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.
Receives: Procedure: adrenal venous sampling

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

Secondary outcomes (9)
  1. 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

  2. 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

  3. Selection of intraoperative catheter

    Types of catheter at the time of Adrenal Venous Sampling via antecubital approach or femoral approach

    Measured: At AVS procedure

  4. Time of the procedure

    Time of the procedure

    Measured: At AVS procedure

  5. Time of fluoroscopy

    Time of fluoroscopy

    Measured: At AVS procedure

  6. The contrast agent dosage

    The contrast agent dosage

    Measured: At AVS procedure

  7. 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

  8. the cost of the procedure

    the cost of the procedure

    Measured: At AVS procedure

  9. pathological results(If the patient underwent adrenalectomy)

    Pathological types of primary aldosteronism(to compare the consistency between adrenal venous sampling results and histopathological results if the patients underwent adrenalectomy.)

    Measured: 1 week After AVS procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jan 2024
  2. Study start1 Jan 2024 (estimated)
  3. Primary completion30 Dec 2026 (estimated)
  4. Study completion30 Dec 2026 (estimated)

Resources

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
1,500 participants (estimated)
Target duration
3 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT06192238
Sponsor's protocol ID
20231120
Acronym
CNAVS
Status last verified
Jan 2024
First submitted
21 Dec 2023
Last updated
9 Jan 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Hyperaldosteronism, run by Chinese Academy of Medical Sciences, Fuwai Hospital at 48 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 3 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: opening soon, as of the sponsor's last update on 9 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 48 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 Xiongjing Jiang, MD (86-010-88322387, jxj103@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The success rate of bilateral adrenal venous sampling (time frame: At 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 9 Jan 2024.

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