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.
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.
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
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.
- Conditions
- Hyperaldosteronism
- 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 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.
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)
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
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
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.
- First posted5 Jan 2024
- Study start1 Jan 2024 (estimated)
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2026 (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.
- More trials run by Chinese Academy of Medical Sciences, Fuwai HospitalThe sponsor's other registered studies.
- 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
- 1,500 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiongjing Jiang, Chinese Academy of Medical Sciences, Fuwai Hospital
- Investigators
- Xiongjing Jiang, 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
- 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
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A National Multicenter Study of Adrenal Venous Sampling for the Subtype Diagnosis of Primary Aldosteronism in China
- ClinicalTrials.gov ID
- NCT06192238
- Acronym / sponsor ID
- CNAVS / 20231120
- Conditions
- Hyperaldosteronism
- Keywords
- Adrenal venous sampling, Hyperaldosteronism, Antecubital approach, Femoral approach, Pathological results
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Chinese Academy of Medical Sciences, Fuwai HospitalUniversity, hospital or other
- Study start
- 1 Jan 2024 (estimated)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 5 Jan 2024 (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.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 3 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 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with confirmed primary aldosteronism aged from 18 to 65 with no limits in sex
Key inclusion criteria (3 listed)
- 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；
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
The success rate of bilateral adrenal venous sampling
Time frame: At AVS procedure
Successful sampling will be defined by high selectivity index (cortisol in the adrenal vein/cortisol in inferior vena cava >2 without ACTH simulation)
9 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
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
pathological results（If the patient underwent adrenalectomy）
Time frame: 1 week 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 9 Jan 2024.
Related trials for Hyperaldosteronism
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SYH2072 Tablets in Participants With Primary Aldosteronism
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Trial of Aldosterone-hybrid SteRoid for Guiding curablE Treatment of Primary Aldosteronism (TARGET-PA)
Hyperaldosteronism; Primary, Primary Aldosteronism Due to Aldosterone Producing Adenoma
RecruitingObservational study
Adrenal Diseases in the Population of Modena: A Clinical-Epidemiological Database of Patients Referred to the Adrenal Disorders Outpatient Clinic of the Clinical Unit of Endocrinology at the Modena University Hospital (AOU Modena)
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Active, not recruiting
Electronic Alert to Improve Testing For Primary Aldosteronism in Patients With Hypertension
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RecruitingObservational study
Kidney Stiffness Measured by Ultrasound in Patients With High Blood Pressure and Healthy Volunteers
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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.
Xiongjing Jiang, MD principal investigator
Fuwai Hospital, National Center for Cardiovascular Disease, Chinese Academy of Medical Sciences and Peking Union Medical College
48 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, 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; AzTrials last refreshed its copy on 7 Nov 2026.