China National Study of Adrenal Venous Sampling (CNAVS)

January 5, 2024 updated by: Xiongjing Jiang, Chinese Academy of Medical Sciences, Fuwai Hospital

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100034
      • Beijing, Beijing, China, 100029
        • China-Japan Friendship Hospital
        • Contact:
        • Principal Investigator:
          • Wuqiang Che, MD
      • Beijing, Beijing, China, 101100
        • Beijing Luhe Hospital, Capital Medical University
        • Contact:
        • Contact:
        • Principal Investigator:
          • Dong Zhao, MD，PHD
      • Beijing, Beijing, China, 100022
        • Chuiyangliu Hospital affiliated to Tsinghua University
        • Contact:
        • Contact:
        • Principal Investigator:
          • Lin Pi, MD
      • Beijing, Beijing, China, 100037
        • Fuwai Hospital, National Center for Cardiovascular Disease, Chinese Academy of Medical Sciences and Peking Union Medical College
        • Principal Investigator:
          • Hui Dong, MD
        • Contact:
        • Contact:
        • Principal Investigator:
          • Xiongjing Jiang, MD
    • Chongqing
      • Chongqing, Chongqing, China, 400000
        • The First Affiliated Hospital of Chongqing Medical University
        • Contact:
        • Contact:
        • Principal Investigator:
          • Dongying Zhang, MD
      • Chongqing, Chongqing, China, 401147
        • Chongqing General Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Rui He, MM
      • Chongqing, Chongqing, China, 404100
        • People's Hospital Affiliated to ChongqingThree Gorges Medical college
        • Contact:
        • Principal Investigator:
          • Xianhu Luo, MD
    • Fujian
      • Xiamen, Fujian, China, 361016
        • Cardiovascular Hospital Xiamen University
        • Contact:
        • Contact:
        • Principal Investigator:
          • Tao Ye, MD
    • Gansu
      • Lanzhou, Gansu, China, 730000
        • Lanzhou University Second Hospital
        • Contact:
        • Contact:
          • Heng Yu
        • Principal Investigator:
          • Wei Liang, MD
    • Guangdong
      • Foshan, Guangdong, China, 528211
        • The Forth People's Hosptal of Nanhai District of Foshan City
        • Contact:
        • Principal Investigator:
          • Yayan Han, MD
      • Guangzhou, Guangdong, China, 510080
        • Guangdong Provincial People's Hospital (Guangdong Academy of Medical Sciences)
        • Principal Investigator:
          • Yingqing Feng, MD
        • Contact:
        • Contact:
      • Shenzhen, Guangdong, China, 518112
        • Shenzhen Third People's Hospital，Shenzhen, Guangdong Province 518112, China
        • Contact:
        • Principal Investigator:
          • Zhenzhong Zheng, MD,PHD
      • Shenzhen, Guangdong, China, 518116
        • Shenzhen Dapeng New District Kuiyong People's Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Tongqing Lu, MD
    • Guangxi
      • Nanning, Guangxi, China, 530000
        • The First Affiliated Hospital of Guangxi Medical University
        • Contact:
        • Contact:
          • Jianling LI
        • Principal Investigator:
          • Jiangnan Huang, MD
      • Nanning, Guangxi, China, 547000
        • Nanning Third People's Hospital
        • Contact:
          • Yongqi Xiao, MS
          • Phone Number: 86-07713394390
        • Contact:
        • Principal Investigator:
          • Yongqi Xiao, MS
    • Guizhou
      • Kaili, Guizhou, China, 556000
        • The Second Affiliated Hospital of Guizhou Medical University
        • Contact:
        • Contact:
        • Principal Investigator:
          • Yumei Xiang, MD
    • Hebei
      • Tangshan, Hebei, China, 063000
    • Heilongjiang
      • Ha'erbin, Heilongjiang, China, 150001
        • The First Affiliated Hospital of Harbin Medical University
        • Contact:
        • Contact:
        • Principal Investigator:
          • Dechao Zhao, MD
    • Henan
      • Zhengzhou, Henan, China, 450003
        • Henan Provincial People's Hospital
        • Principal Investigator:
          • Min Liu, MD
        • Contact:
        • Contact:
      • Zhengzhou, Henan, China, 450000
        • Fuwai Central China Cardiovascular Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Qiuping Zhao, PhD
      • Zhengzhou, Henan, China, 450007
        • Zhengzhou Central Hospital Affiliated to Zhengzhou University
        • Contact:
        • Contact:
        • Principal Investigator:
          • Shuhua Yu, MM
      • Zhengzhou, Henan, China, 450018
        • Zhengzhou Yihe Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Liang An, BD
      • Zhoukou, Henan, China, 466000
        • Zhoukou Central Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Baogong Wang, MD
    • Hubei
      • Xiangyang, Hubei, China, 441021
        • Xiangyang Central Hospital, Affiliated Hospital of Hubei University of Arts and Science
        • Contact:
        • Contact:
          • Luhong Li
        • Principal Investigator:
          • Qing'an Li
      • Yichang, Hubei, China, 443000
        • Yichang Central People's Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Yunbo Lv, MD
    • Jiangxi
      • Nanchang, Jiangxi, China, 330006
        • Second Affiliated Hospital of Nanchang University
        • Contact:
        • Contact:
        • Principal Investigator:
          • Yifei Dong, MD，PhD
      • Nanchang, Jiangxi, China, 330038
        • Jiangxi Provincial People's Hospital (The First Affiliated Hospital of Nanchang Medical College)
        • Contact:
          • Haohang Ruan, MBBS
          • Phone Number: 86-0791-87721036
        • Contact:
        • Principal Investigator:
          • Haohang Ruan, MBBS
    • Jilin
      • Changchun, Jilin, China, 130051
        • Jilin Province FAW General ospital
        • Contact:
        • Principal Investigator:
          • Wenhai Wang, MM
    • Liaoning
      • Dalian, Liaoning, China, 116011
        • Frist Aiffiliated Hospital of Dalian Medical University
        • Contact:
        • Contact:
        • Principal Investigator:
          • Yinong Jiang, MD
    • Ningxia
      • Yinchuan, Ningxia, China, 750000
        • The First People's Hospital of Yinchuan
        • Contact:
        • Contact:
          • Yunhai Ma
        • Principal Investigator:
          • Fang Chen, PD
    • Qinghai
      • Xining, Qinghai, China, 810000
        • Qinghai Province Cardiovascular and Cerebrovascular Disease Specialist Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Xiaozhou Wang
    • Shaanxi
      • Xi'an, Shaanxi, China, 710018
        • Xi'an People's Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Kang Cheng, MD&PhD
    • Shandong
      • Jinan, Shandong, China, 250012
      • Jinan, Shandong, China, 250013
        • Central Hospital Affiliated to Shandong First Medical University
        • Contact:
        • Contact:
        • Principal Investigator:
          • Rui Xu, MD &. PhD
      • Liaocheng, Shandong, China, 252200
        • People's Hospital of Donga County, Shandong Province
        • Contact:
        • Contact:
        • Principal Investigator:
          • Xiaoli Wang, MD
    • Shanghai
      • Shanghai, Shanghai, China, 200062
        • Shanghai Putuo District Central Hospital
        • Contact:
          • Junqing Gao
        • Contact:
        • Principal Investigator:
          • Zongjun Liu, MD
      • Shanghai, Shanghai, China, 200025
        • Shanghai Institute of Hypertension, Ruijin Hospital, Shanghai Jiaotong University School of Medicine
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jianzhong Xu, MD，PhD
    • Shanxi
      • Taiyuan, Shanxi, China, 030001
        • the second hospital of ShanXi medical unversity
        • Principal Investigator:
          • Bin Yang, MD
        • Contact:
        • Contact:
    • Sichuan
      • Chengdu, Sichuan, China, 611130
        • Chengdu Fifth People's Hospital
        • Contact:
          • Mingjian Lang, MD
          • Phone Number: 86-028-82710681
          • Email: zcl628@163.com
        • Contact:
          • Congliang Zhou
        • Principal Investigator:
          • Mingjian Lang, MD
      • Chengdu, Sichuan, China, 610500
        • The First Affiliated Hospital of Chengdu Medical College
        • Contact:
        • Contact:
        • Principal Investigator:
          • Peijian Wang, MD
      • Chengdu, Sichuan, China, 610031
        • The Affiliated Hospital of Southwest Jiaotong University, The Third People's Hospital of Chengdu, Chengdu, China
        • Contact:
        • Contact:
        • Principal Investigator:
          • Zhen Zhang, MD
    • Tianjin
      • Tianjin, Tianjin, China, 300457
        • Teda International Cardiovascular Hospital
        • Contact:
        • Principal Investigator:
          • Weiqiang Chen, MM
      • Tianjin, Tianjin, China, 300211
        • The Second Hospital of Tianjin Medical University
        • Contact:
        • Contact:
        • Principal Investigator:
          • Changle Liu, MD
      • Tianjin, Tianjin, China, 300052
        • Tianjin Medical University General Hospital,
        • Contact:
        • Contact:
        • Principal Investigator:
          • Dianxun Fu, MD
    • Xinjiang
      • Yili Kazak Autonomous Prefecture, Xinjiang, China, 835000
        • Yili Kazak Autonomous Prefecture Friendship Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Wei Li, MB
    • Yunnan
      • Kunming, Yunnan, China, 650102
        • Fuwai Yunnan Cardiovascular Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Zihong Guo, Bachelor
    • Zhejiang

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

  1. Severe comorbidity, including stroke, myocardial infarction, heart failure, severe valvular heart disease, liver cirrhosis, and metastatic tumor within the previous 3 months；
  2. An estimated glomerular filtration rate <45 ml/min/1.73 m2, or serum creatinine >176 μmol/L；
  3. Patients who refuse adrenalectomy;
  4. Suspected of having an adrenocortical carcinoma;
  5. Allergy to contrast agent;
  6. Pregnant, nursing, or planning to become pregnant

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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)
At AVS procedure

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The success rate of left 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)
At AVS procedure
The success rate of right 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)
At AVS procedure
Time of the procedure
Time Frame: At AVS procedure
Time of the procedure
At AVS procedure
Time of fluoroscopy
Time Frame: At AVS procedure
Time of fluoroscopy
At AVS procedure
The contrast agent dosage
Time Frame: At AVS procedure
The contrast agent dosage
At AVS procedure
the incidence of complications
Time Frame: 1 week after AVS procedure
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
Time Frame: At AVS procedure
the cost of the procedure
At AVS procedure
Selection of intraoperative catheter
Time Frame: At AVS procedure
Types of catheter at the time of Adrenal Venous Sampling via antecubital approach or femoral approach
At AVS procedure
pathological results（If the patient underwent adrenalectomy）
Time Frame: 1 week After AVS procedure
Pathological types of primary aldosteronism（to compare the consistency between adrenal venous sampling results and histopathological results if the patients underwent adrenalectomy.）
1 week After AVS procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Chinese Academy of Medical Sciences, Fuwai Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Xiongjing Jiang, MD, Fuwai Hospital, National Center for Cardiovascular Disease, Chinese Academy of Medical Sciences and Peking Union Medical College

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 30, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 21, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 4, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 5, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 9, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 5, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 20231120

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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